OCTOBER 2008
WEEK ENDING OCTOBER 4
PRODUCT
a) Medtronic INDURA 1P Intrathecal Catheter, model 8709SC. 81.4 cm catheter
with length markers and guide wire, 15 T-gauge introducer needle, Sutureless
pump connector with attached 7.6 cm catheter and connector pin, Transparent
Strain-relief sleeves (2), Anchors (4),
b)
Medtronic Intrathecal Catheter, model 8731SC. 38.1 cm spinal segment with length
markers and guide wire, 66 cm pump segment, separate connector pin, 15T
gauge introducer needles (2) (11.4 cm and 9.3 cm), Transparent strain-relief
sleeves (2), Opaque Strain-relief sleeves (2), V-wing Anchors (2),
c) Medtronic Sutureless Pump Connector Revision Kit, model
8578.
Contents: Catheter interface with attached sutureless pump connector,
catheter, connector pin, and strain-relief sleeve, Strain-relief Sleeves
(2),
d) Medtronic Intrathecal Catheter Pump Segment
Revision Kit, model 8596SC. Contents: 66-cm pump segment with attached
sutureless pump connector, spinal segment strain-relief sleeves (2), Pump
segment strain-relief sleeves (2), Connector pin,
CODE All SC Catheter Pump Revision
Kits
RECALLING FIRM/MANUFACTURER Medtronic Neuromodulation, Minneapolis, MN,
REASON
Disconnection of the Medtronic
sutureless connector (SC) catheters from the catheter port on the pump, or
occlusion between the sutureless pump connector and the catheter port on the
pump.
VOLUME OF PRODUCT IN COMMERCE 21,674
devices
DISTRIBUTION Nationwide and Internationally
PRODUCT Xmatrx FISH (fluorescent in situ hybridization) Automated Staining System,
Catalog number AS4010B, CODE Serial
numbers: AS40211, AS40226, AS40230, AS40231, AS40232, AS40233, AS40234, AS40235,
AS40236, AS40237
RECALLING FIRM/MANUFACTURER Biogenex
Laboratories, San Ramon, CA,
REASON Bulk reagent dispensing
mechanism may break resulting in reagent spill and possible exposure to
chemicals.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION Nationwide
PRODUCT
a) GE Definium 8000, model 5135678, Digital Radiographic Systems,
b) GE Precision 500D, model 2403790-3, Radiographic and
Fluoroscopic Systems,
CODE
a)
Serial numbers: 0000000002772E, 00000001191M36, 00000002065M31, 00000002650M30,
00000002753EN2, 00000002767EN2, 00000002968M36, 00000003505M35, 00000003806M37,
00000004101M32, 00000004547M36, 00000005487M34, 00000096383DP5, 00000097656DP3,
00000100740WK6, 00000114297VE5, 00000989905WK5, 00000992237WK8, 00000992321WK0,
00000992949WK8, 00000992952WK2, 00000993284WK9, 00000993807WK7, 00000994376WK2,
00000994685WK6, 00000994845WK6, 00000995791WK1, 00000995797WK8, 00000995798WK6,
00000995799WK4, 00000996181WK4, 00000996289WK5, 00000996290WK3, 00000996629WK2,
00000996739WK9, 00000996745WK6, 00000996977WK5, 00000997197WK9, 00000997198WK7,
00000997265WK4, 00000997333WK0, 00000997803WK2, 00000997808WK1, 00000997809WK9,
00000997885WK9, 00000997887WK5, 00000998455WK0, 00000998632WK4, 00000TA42184-1,
00001001026WK2, 00001001592WK3, 00001003410WK6, 00001003576WK4, 00001003925WK3,
00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004158WK0, 00001004163WK0,
00001004330WK5, 00001004331WK3, 00001004332WK1, 00001004504WK5, 00001004770WK2,
00001004771WK0, 00001004772WK8, 00001004884WK1, 00001005016WK9, 00001005017WK7,
00001005018WK5, 00001005019WK3, 00001005020WK1, 00001005021WK9, 00001005022WK7,
00001005023WK5, 00001005024WK3, 00001005026WK8, 00001005027WK6, 00001005029WK2,
00001005030WK0, 00001005031WK8, 00001005033WK4, 00001005034WK2, 00001005179WK5,
00001005181WK1, 00001005184WK5, 00001005188WK6, 00001005260WK3, 00001005698WK4,
00001005757WK8, 00001005762WK8, 00001005764WK4, 00001005841WK0, 00001005912WK9,
00001006015WK0, 00001006040WK8, 00001006043WK2, 00001006044WK0, 00001006178WK6,
00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5, 00001006474WK9,
00001006475WK6, 00001006476WK4, 00001006633WK0, 00001006637WK1, 00001006664WK5,
00001006666WK0, 00001006668WK6, 00001006822WK9, 00001006833WK6, 00001006871WK6,
00001006872WK4, 00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006878WK1,
00001006880WK7, 00001007160WK3, 00001007161WK1, 00001007162WK9, 00001007165WK2,
00001007166WK0, 00001007192WK6, 00001007476WK3, 00001007478WK9, 00001007498WK7,
00001007499WK5, 00001007517WK4, 00001007525WK7, 00001007528WK1, 00001007529WK9,
00001007530WK7, 00001007531WK5, 00001007532WK3, 00001007534WK9, 00001007535WK6,
00001007536WK4, 00001007563WK8, 00001007642WK0, 00001007643WK8, 00001007644WK6,
00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007651WK1, 00001007715WK4,
00001007716WK2, 00001007717WK0, 00001007718WK8, 00001007719WK6, 00001007720WK4,
00001007776WK6, 00001007781WK6, 00001007785WK7, 00001007786WK5, 00001007787WK3,
00001007788WK1, 00001007903WK6, 00001007904WK4, 00001007905WK1, 00001007906WK9,
00001007907WK7, 00001007908WK5, 00001007909WK3, 00001007910WK1, 00001007911WK9,
00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5, 00001008311WK1,
00001008312WK9, 00001008313WK7, 00001008314WK5, 00001008315WK2, 00001008316WK0,
00001008498WK6, 00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008684WK1,
00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8,
00001008691WK6, 00001008811WK0, 00001008813WK6, 00001008814WK4, 00001008840WK9,
00001008995WK1, 00001009057WK9, 00001009059WK5, 00001009062WK9, 00001009063WK7,
00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009140WK3, 00001009142WK9,
00001009144WK5, 00001009145WK2, 00001009147WK8, 00001009213WK8, 00001009217WK9,
00001009218WK7, 00001009219WK5, 00001009220WK3, 00001009222WK9, 00001009252WK6,
00001009264WK1, 00001009265WK8, 00001009267WK4, 00001009269WK0, 00001009271WK6,
00001009273WK2, 00001009374WK8, 00001009375WK5, 00001009376WK3, 00001009377WK1,
00001009378WK9, 00001009380WK5, 00001009381WK3, 00001009382WK1, 00001009528WK9,
00001009529WK7, 00001009530WK5, 00001009533WK9, 00001009534WK7, 00001009536WK2,
00001009537WK0, 00001009592WK5, 00001009604WK8, 00001009605WK5, 00001009606WK3,
00001009609WK7, 00001009707WK9, 00001009708WK7, 00001009709WK5, 00001009710WK3,
00001009712WK9, 00001009713WK7, 00001009716WK0, 00001009816WK8, 00001009817WK6,
00001009819WK2, 00001009821WK8, 00001009823WK4, 00001009876WK2, 00001009930WK7,
00001009931WK5, 00001009938WK0, 00001009976WK0, 00001009977WK8, 00001009979WK4,
00001010086WK5, 00001010098WK0, 00001010101WK2, 00001010102WK0, 00001010106WK1,
00001010107WK9, 00001010157WK4, 00001010159WK0, 00001010161WK6, 00001010162WK4,
00001010169WK9, 00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010240WK8,
00001010243WK2, 00001010291WK1, 00001010292WK9, 00001010293WK7, 00001010295WK2,
00001010296WK0, 00001010297WK8, 00001010298WK6, 00001010299WK4, 00001010300WK0,
00001010348WK9, 00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7,
00001010356WK2, 00001010357WK0, 00001010431WK3, 00001010432WK1, 00001010433WK9,
00001010488WK3, 00001010489WK1, 00001010490WK9, 00001010521WK1, 00001010523WK7,
00001010524WK5, 00001010526WK0, 00001010527WK8, 00001010528WK6, 00001010530WK2,
00001010625WK0, 00001010626WK8, 00001010627WK6, 00001010629WK2, 00001010631WK8,
00001010632WK6, 00001010633WK4, 00001010695WK3, 00001010696WK1, 00001010723WK3,
00001010804WK1, 00001010904WK9, 00001010906WK4, 00001010907WK2, 00001010908WK0,
00001010962WK7, 00001011079WK9, 00001011081WK5, 00001011085WK6, 00001011086WK4,
00001011088WK0, 00001011091WK4, 00001011092WK2, 00001011210WK0, 00001011211WK8,
00001011212WK6, 00001011213WK4, 00001011215WK9, 00001011218WK3, 00001011219WK1,
00001011283WK7, 00001011284WK5, 00001011285WK2, 00001011286WK0, 00001011287WK8,
00001011288WK6, 00001011289WK4, 00001011290WK2, 00001011291WK0, 00001011292WK8,
00001011330WK6, 00001011380WK1, 00001011382WK7, 00001011383WK5, 00001011387WK6,
00001011388WK4, 00001011389WK2, 00001011449WK4, 00001011452WK8, 00001011454WK4,
00001011485WK8, 00001011486WK6, 00001011488WK2, 00001011489WK0, 00001011490WK8,
00001011491WK6, 00001011494WK0, 00001011495WK7, 00001011496WK5, 00001011630WK9,
00001011631WK7, 00001011632WK5, 00001011633WK3, 00001011634WK1, 00001011635WK8,
00001011643WK2, 00001011648WK1, 00001011654WK9, 00001011697WK8, 00001011700WK0,
00001011703WK4, 00001011715WK8, 00001011716WK6, 00001011821WK4, 00001011822WK2,
00001011824WK8, 00001011825WK5, 00001011826WK3, 00001011827WK1, 00001011828WK9,
00001011829WK7, 00001011830WK5, 00001011831WK3, 00001011832WK1, 00001011926WK1,
00001011928WK7, 00001011962WK6, 00001012011WK1, 00001012012WK9, 00001012013WK7,
00001012014WK5, 00001012015WK2, 00001012117WK6, 00001012118WK4, 00001012119WK2,
00001012120WK0, 00001012121WK8, 00001012122WK6, 00001012164WK8, 00001012165WK5,
00001012173WK9, 00001012278WK6, 00001012280WK2, 00001012284WK4, 00001012285WK1,
00001012299WK2, 00001012428WK7, 00001012429WK5, 00001012430WK3, 00001012450WK1,
00001012452WK7, 00001012593WK8, 00001012594WK6, 00001012622WK5, 00001012923WK7,
00001012925WK2, 00001012927WK8, 00001012928WK6, 00001012929WK4, 00001012930WK2,
00001012931WK0, 00001013005WK2, 00001013025WK0, 00001013064WK9, 00001013100WK1,
00001013101WK9, 00001013136WK5, 00001013143WK1, 00001013145WK6, 00001013222WK3,
00001013223WK1, 00001013224WK9, 00001013225WK6, 00001013305WK6, 00001013306WK4 ,
00001013334WK6, 00001013335WK3, 00001013336WK1, 00001013337WK9, 00001013621WK6,
00001013622WK4, 00001015809WK5, 00002UA5040SGX, 00002UA52707GV;
b) Serial
numbers: 00001014958WK1, 100963570, 00000086203DP7, 00000086475DP1,
00000086507DP1, 00000089131DP7, 00000993365WK6, 00000994505WK6, 00000995353WK0,
00000996209WK3, 00000996212WK7, 00000996789WK4, 00001000009WK9, 00001002273WK9,
00001002491WK7, 00001009077WK7, 00001009774WK9, 00001009986WK9, 00001010013WK9,
00001010015WK4, 00001010016WK2, 00001010017WK0, 00001010018WK8, 00001010020WK4,
00001010021WK2, 00001010059WK2, 00001010060WK0, 00001010061WK8, 00001010062WK6,
00001010063WK4, 00001010064WK2, 00001010065WK9, 00001010066WK7, 00001010068WK3,
00001010091WK5, 00001010120WK2, 00001010208WK5, 00001010209WK3, 00001010210WK1,
00001010212WK7, 00001010213WK5, 00001010214WK3, 00001010216WK8, 00001010217WK6,
00001010287WK9, 00001010328WK1, 00001010329WK9, 00001010330WK7, 00001010333WK1,
00001010334WK9, 00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0,
00001010551WK8, 00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9,
00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010746WK4,
00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3, 00001010856WK1,
00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9, 00001010863WK7,
00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8, 00001011014WK6,
00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1,
00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7,
00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6,
00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 00001011327WK2,
00001011328WK0, 00001011341WK3, 00001011342WK1, 00001011343WK9, 00001011344WK7,
00001011345WK4, 00001011346WK2, 00001011347WK0, 00001011348WK8, 00001011349WK6,
00001011513WK7, 00001011514WK5, 00001011515WK2, 00001011516WK0, 00001011517WK8,
00001011518WK6, 00001011519WK4, 00001011520WK2, 00001011521WK0, 00001011657WK2,
00001011762WK0, 00001011763WK8, 00001011764WK6, 00001011765WK3, 00001011766WK1,
00001011767WK9, 00001011768WK7, 00001011769WK5, 00001011770WK3, 00001011875WK0,
00001011876WK8, 00001011877WK6, 00001011878WK4, 00001011879WK2, 00001011887WK5,
00001011888WK3, 00001011889WK1, 00001011890WK9, 00001011891WK7, 00001012024WK4,
00001012025WK1, 00001012026WK9, 00001012027WK7, 00001012028WK5, 00001012029WK3,
00001012030WK1, 00001012031WK9, 00001012032WK7, 00001012033WK5, 00001012176WK2,
00001012177WK0, 00001012178WK8, 00001012179WK6, 00001012180WK4, 00001012181WK2,
00001012182WK0, 00001012183WK8, 00001012186WK1, 00001012187WK9, 00001012188WK7,
00001012189WK5, 00001012190WK3, 00001012191WK1, 00001012192WK9, 00001012193WK7,
00001012194WK5, 00001012195WK2, 00001012432WK9, 00001012434WK5, 00001012435WK2,
00001012499WK8, 00001012500WK3, 00001012501WK1, 00001012502WK9, 00001012503WK7,
00001012505WK2, 00001012506WK0, 00001012508WK6, 00001012541WK7, 00001012542WK5,
00001012543WK3, 00001012546WK6, 00001012547WK4, 00001012548WK2, 00001012549WK0,
00001012881WK7, 00001012883WK3, 00001012884WK1, 00001012885WK8, 00001012888WK2,
00001012889WK0, 00001012991WK4, 00001012992WK2, 00001012993WK0, 00001012995WK5,
00001012996WK3, 00001012997WK1, 00001013087WK0, 00001013088WK8, 00001013089WK6,
00001013090WK4, 00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7,
00001013179WK5, 00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5,
00001013185WK2, 00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1,
00001013302WK3, 00001013576WK2, 00001013577WK0, 00001013578WK8, 00001013579WK6,
00001013580WK4, 00001013581WK2, 00001013582WK0, 00001013583WK8, 00001013584WK6,
00001013585WK3, 00001013726WK3, 00001013728WK9, 00001013729WK7, 00001013731WK3,
00001013732WK1, 00001013733WK9, 00001013734WK7, 00001013735WK4, 00001013968WK1,
00001013969WK9, 00001013970WK7, 00001013974WK9, 00001013976WK4, 00001013977WK2,
00001014092WK9, 00001014093WK7, 00001014095WK2, 00001014097WK8, 00001014098WK6,
00001014099WK4, 00001014279WK2, 00001014280WK0, 00001014392WK3, 00001014394WK9,
00001014395WK6, 00001014397WK2, 00001014398WK0, 00001014549WK8, 00001014550WK6,
00001014551WK4, 00001014553WK0, 00001014556WK3, 00001014702WK3, 00001014703WK1,
00001014704WK9, 00001014705WK6, 00001014706WK4, 00001014707WK2, 00001014710WK6,
00001014711WK4, 00001014866WK6, 00001014953WK2, 00001014959WK9, 00001014960WK7,
00001014961WK5, 00001014962WK3, 00001015088WK6, 00001015092WK8, 00001015093WK6,
00001015096WK9, 00001015219WK7, 00001015220WK5, 00001015292WK4, 00001015293WK2,
00001015295WK7, 00001015297WK3, 00001015298WK1, 00001015559WK6, 00001015563WK8,
00001015689WK1, 00002AU53105K0, 00002UA4490WQG, 00002UA4490WQM, 00002UA4490WQV,
00002UA4510C3B, 00002UA4510C3J, 00002UA45200NH, 00002UA45200NM, 00002UA45200NR,
00002UA45200QY, 00002UA50306KL, 00002UA50306KT, 00002UA50306KW, 00002UA50306L6,
00002UA50306L7, 00002UA50306L8, 00002UA50306LD, 00002UA5030PTY, 00002UA5030PTZ,
00002UA5030PV2, 00002UA5040SH5, 00002UA504DSH3, 00002UA504OSH5, 00002UA5050FP7,
00002UA5080W88, 00002UA5080W89, 00002UA5100TCV, 00002UA510147Y, 00002UA51411JC,
00002UA51411JF, 00002UA51411JG, 00002UA51411JM, 00002UA51411JN, 00002UA51411JT,
00002UA51411JY, 00002UA51411JZ, 00002UA51604QS, 00002UA51604QV, 00002UA51604QY,
00002UA51604R2, 00002UA51604R3, 00002UA51604R4, 00002UA51604R6, 00002UA51604R9,
00002UA51604RH, 00002UA51701BZ, 00002UA51701C2, 00002UA51701C5, 00002UA51701C6,
00002UA51701C8, 00002UA51701CH, 00002UA52111XQ, 00002UA52111XR, 00002UA52111XS,
00002UA52111XT, 00002UA52111XV, 00002UA52111XW, 00002UA52111XX, 00002UA5220564,
00002UA5220BKM, 00002UA5220BKP, 00002UA5220BKV, 00002UA5220S5X, 00002UA5220S5Y,
00002UA5220S5Z, 00002UA5220S62, 00002UA5220S63, 00002UA52606Q5, 00002UA52606QC,
00002UA52606QD, 00002UA52707GY, 00002UA52707GZ, 00002UA527115R, 00002UA527115V,
00002UA527115Z, 00002UA5290DD1, 00002UA5290DD2, 00002UA53006LM, 00002UA53006LN,
00002UA53006LP, 00002UA53006LR, 00002UA53006LS, 00002UA53006LT, 00002UA53006LV,
00002UA5320FKJ, 00002UA5320FKM, 00002UA5320FKN, 00002UA5320FKR, 00002UA53405P5,
00002UA53405P7, 00002UA53405P9, 00002UA53405PG, 00002UA5340LCV, 00002UA5340LCY,
00002UA5340VDC, 00002UA5340VDG, 00002UA5340VDK, 00002UA5340VDL, 00002UA535112H,
00002UA5360CBD, 00002UA5360CBG, 00002UA5360CBM, 00002UA5360CBN, 00002UA53707WM,
00002UA53707WQ, 00002UA53707WR, 00002UA53802GP, 00002UA5400VB7, 00002UA5400VB8,
00002UA541113W, 00002UA541113X, 00002UA5411140, 00002UA5411142, 00002UA5411143,
00002UA5411144, 00002UA5411146, 00002UA5411147, 00002UA5411148, 00002UA5411149,
00002UA541114B, 00002UA541114H, 00002UA542046N, 00002UA542046P, 00002UA542046Q,
00002UA542046R, 00002UA542046T, 00002UA542046V, 00002UA5420VPK, 00002UA5420VPM,
00002UA5420VPP, 00002UA5430X4Y, 00002UA5440B2V, 00002UA5440B2W, 00002UA5450SNN,
00002UA5450SNR, 00002UA5450SNY, 00002UA60200GH, 00002UA606KJH4, 00002UA606KJH7,
00002UA615JV3C, 0000USU4350N51, 0000USU4400NXF, 0000USU4400NXJ, 0000USU4400NXQ,
0000USU4400NXV, 0000USU4400NXW, 0000USU4400NXY, 0000USU4400NY0, 00010103324WK3,
0UNK2289299-01, , 00000114134VE0
RECALLING
FIRM/MANUFACTURER GE Healthcare, Waukesha, WI,
REASON
Necessary
certification labels are missing from the x-ray control.
VOLUME OF
PRODUCT IN COMMERCE 885
systems
DISTRIBUTION Nationwide, Italy, Japan, Spain and
Turkey
PRODUCT
1)
Zimmer H.A.S. Autotransfusion System, H.A.S. Kit with 1/8" Drain , 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only; REF 00-2555-020-05,
2) Zimmer
H.A.S. Autotransfusion System, H.A.S. Kit with
3/16" Soft Drain , 4,8mm, 15Fr, PVC, 107cm, firm, sterile, latex free, Rx
only; REF 00-2555-030-05,
3) Zimmer H.A.S.
Autotransfusion System, H.A.S. Kit with 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm,
large, sterile, latex free, Rx only; REF 00-2555-040-05,
4) Zimmer
H.A.S. Autotransfusion System, H.A.S. Replacement
Kit, sterile, latex free, Rx only; REF 00-2555-050-05,
5) Zimmer H.A.S. Autotransfusion System,
H.A.S. Kit without
Drain, sterile, latex free, Rx only; REF 00-2555-060-05,
6) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 1/8"
PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium, sterile, latex free, Rx only;
REF 00-2500-000-10,
7) Zimmer Hemovac Wound
Drainage Device, 400ml Comp Bonded Evac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC,
107cm, medium, sterile, latex free, Rx only; REF 00-
2500-700-10,
8) Zimmer Hemovac Wound Drainage Device, 400ml Comp Evac 3/16"
PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only;
REF 00-2505-000-10,
9) Zimmer Hemovac Wound Drainage
Device, 400ml Comp Bonded Evac 3/16" PVC w/trocar, 4,8mm, 15Fr, PVC, 107cm,
soft, sterile, latex free, Rx only; REF 00-2505-
700-10,
10) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, 400ml Infection Control Kit w/ 3/32" Drain, 2,4mm, 7Fr, PVC, 107cm,
small, sterile, latex free, Rx
only; REF 00-2550-001-10,
11) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, 400ml Infection Control Kit w/ 1/8" Drain, 3,2mm, 10Fr, PVC, 107cm,
medium, sterile, latex free,
Rx only; REF 00-2550-002-10,
12) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, 400ml Infection Control Kit w/ 3/16" Drain, 4,8mm, 15Fr, PVC, 107cm,
soft, sterile, latex free,
Rx only; REF 00-2550-003-10,
13) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, 400ml Infection Control Kit w/ 1/4" Drain, 6,4mm, 19Fr, PVC, 107cm,
large, sterile, latex free,
Rx only; REF 00-2550-004-10,
14) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, 400ml Infection Control Kit w/ 1/8" Drain Spec., 3,2mm, 10Fr, PVC,
107cm, medium, sterile, latex
free, Rx only; REF 00-2550-702-10,
15) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, 400ml Infection Control Kit w/ 3/16" Drain Spec., 4,8mm, 15Fr, PVC,
107cm, soft, sterile, latex
free, Rx only; REF 00-2550-703-10,
16) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, 400ml Infection Control Kit w/ 1/4" Drain Spec, 6,4mm, 19Fr, PVC,
107cm, large, sterile, latex free, Rx only; REF 00-2550-704-10,
17) Zimmer Hemovac Wound Drainage Device, Infection Control
Kits, Mini-Hemovac I.C. Kit, sterile, latex free, Rx only; REF
00-2557-000-10,
18) Zimmer Hemovac Wound Drainage
Device, 100 ml Hemovac Mini Evacuator, sterile, latex free, Rx only; REF
00-2568-000-10,
19) immer Hemovac Wound Drainage
Device, 400 ml COMP EVAC 1/4" PVC w/trocar (4"), 6,4mm, 19Fr, PVC, 107cm,
large, sterile, latex free, Rx only; REF 00-2590-000-
10,
20) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 1/4"
PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large, sterile, latex free, Rx only;
REF 00-2590-
040-10,
21) Zimmer Hemovac Wound
Drainage Device, 400 ml EVAC 1/4" DR w/troc spec., 6,4mm, 19Fr, PVC, 107cm,
large, sterile, latex free, Rx only; REF 00-2590-700-10,
22) Zimmer Hemovac Wound Drainage Device, 400 ml COMP EVAC 3/32"
PVC w/trocar, 2,4mm, 7Fr, PVC, 107cm, small, sterile, latex free, Rx only;
REF 00-2595-
000-10,
23) Zimmer Hemovac Wound
Drainage Device with O.P. Adapter, 400 ml COMP EVAC w/O.P. Adapter Component
Kit, to be used with OrthoPAT post op suction set, sterile, latex free, Rx
only; REF 00-2696-000-10,
24) Surgivac Wound Drainage
Device, 400 ml Surgivac 1/8" PVC w/trocar, 3,2mm, 10Fr, PVC, 107cm, medium,
sterile, latex free, Rx only; REF 00-5300-000-05 and
00-5300-000-10,
25) Surgivac Wound Drainage Device, 400 ml Surgivac Component
Kit, sterile, latex free, Rx only; REF 00-5300-004-10;
26) Surgivac Wound Drainage Device, 400 ml Surgivac 3/16" PVC
w/trocar, 4,8mm, 15Fr, PVC, 107cm, soft, sterile, latex free, Rx only; REF
00-5305-000-05 and
00-5305-000-10,
27) Surgivac
Wound Drainage Device, 400 ml Surgivac 1/8" MP Sil w/trocar, 3,2mm, 10Fr, Si, 107cm, medium, sterile, latex free, Rx only; REF 00-5340-000-05 and
00-5340-000-10,
28) Surgivac Wound Drainage Device,
400 ml Surgivac 3/16" MP SIL w/trocar, 4, 8mm, 15Fr, Si, 107cm, soft,
sterile, latex free, Rx only; REF 00-5341-000-05 and
00-5341-000-10,
29) Surgivac Wound Drainage Device, 400 ml Surgivac 1/4" MP
SIL w/trocar, 6,4mm, 19Fr, Si, 107cm, large, sterile, latex free, Rx only;
REF 00-5345-000-10,
30) Surgivac Wound Drainage
Device, 400 ml Surgivac 1/4" PVC w/trocar, 6,4mm, 19Fr, PVC, 107cm, large,
sterile, latex free, Rx only; REF 00-5390-040-10,
CODE All lots manufactured on or before
1/18/08. Product has a 5 year expiration period.
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Zimmer, Inc., Warsaw, IN,
Manufacturer: Zimmer
Orthopedic Surgical Products, Dover, OH.
REASON The sterility of the device may be
compromised due to the possible presence of slits or pinholes in the
packaging.
VOLUME OF PRODUCT IN COMMERCE 377,707
packages
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Stryker Medical Secure II Med/Surg Bed, 115 V, Model 3002,
b) Stryker Medical Epic II Critical Care Bed, 115 V, Model 2030,
c) Stryker Medical Epic II Critical Care Bed with Zoom
Drive System, 115 V, Model 2040,
d) Stryker
Medical Secure II Med/Surg Bed, 230 V, Model 3221 (not sold in the
U.S.),
e) Stryker Medical Epic II Critical Care
Bed, 230 V, Model 2031, (not sold in the U.S.),
CODE
a) Serial numbers 040915077 through
071116347;
b) Serial numbers 0409060501 through 0711096119;
c) Serial
numbers 0409060516 through 0711096116;
d) Serial numbers 040915077 through
071116347;
e) Serial numbers 0409060501 through
0711096119
RECALLING FIRM/MANUFACTURER Stryker Medical
Division of Stryker Corp., Portage, MI,
REASON The brakes may not
have adequate holding power to lock the bed in place.
VOLUME OF
PRODUCT IN COMMERCE 66,558
beds
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Universal Notch Preparation Guide, Size #3; Non Sterile; Catalog Number
7650-3363,
b) X-Celerate Universal Block Pegless
Size #3, Non Sterile; Catalog Number 8000-3303,
CODE All lot codes since
1998
RECALLING FIRM/MANUFACTURER Stryker Howmedica Osteonics, Corp., Mahwah, NJ,
REASON
Discovery of the potential for
Pin and Punch interference of the Size 3 Scorpio Notch Preparation Guide that
may result in damage to bone if a user aggressively attempts to seat an
obstructed punch.
VOLUME OF PRODUCT IN COMMERCE 2,580
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT iLab Ultrasound Imaging System, Models 120INS and 240INS; UPN’s:
H74900036130, H749FG000940, H749ILAB120INS0, H749ILAB120INSR0, H749ILAB220INS0,
H749240INS0, M004EPIL120INS0,
CODE
Serial numbers 0000004082, 0000004385,
0000004386, 0000004387, 0000004388, 0000004389, 0000004390, 0000004391,
0000004392, 0000004393, 0000004396, 0000004397, 0000004398, 0000004399,
0000004416, 0000004417, 0000004418, 0000004419, 0000004420, 0000004421,
0000004422, 0000004423, 0000004424, 0000004425, 0000004426, 0000004427,
0000004428, 0000004429, 0000004430, 0000004431, 0000004432, 0000004433,
0000004434, 0000004435, 0000004436, 0000004439, 0000004441, 0000004442,
0000004443, 0000004444, 0000004445, 0000004446, 0000004447, 0000004448,
0000004453, 0000004454, 0000004455, 0000004456, 0000004468, 0000004469,
0000004472, 0000004473, 0000004480, 0000004487, 0000004488, 0000004489,
0000004490, 0000004491, 0000004494, 0000004495, 0000004496, 0000004497,
0000004498, 0000004505, 0000004506, 0000004507, 0000004512, 0000004513,
0000004514, 0000004515, 0000004516, 0000004520, 0000004521, 0000004522,
0000004523, 0000004524, 0000004525, 0000004526, 0000004529, 0000004538,
0000004539, 0000004548, 0000004549, 0000004550, 0000004551, 0000004556,
0000004557, 0000004558, 0000004559, 0000004564, 0000004565, 0000004566,
0000004567, 0000004572, 0000004573, 0000004574, 0000004575, 0000004580,
0000004581, 0000004582, 0000004583, 0000004584, 0000004585, 0000004586,
0000004587, 0000004610, 0000004702, 0000004703, 0000004704, 0000004705,
0000004717, 0000004718, 0000004719, 0000004720, 0000004726, 0000004728,
0000004729, 0000004730, 0000004731, 0000004732, 0000004737, 0000004738,
0000004751, 0000035228, 0000035229, 0000035390, 0000035391, 0000036314,
0000094718, 0009430893, 0009503458, 0009543381, 0009565345, 0009902558,
0009602559, 0009626567, 0009640091, 0009828054, 0009828055, 0009828344,
0011008866
RECALLING FIRM/MANUFACTURER Boston Scientific
Corp., Fremont, CA,
REASON Improperly terminated wires on a
component of the iLab Acquisition processor power supply could cause the
processor to lock-up or stop, and prolong the patient’s
procedure.
VOLUME OF PRODUCT IN COMMERCE 120
units
DISTRIBUTION Nationwide, Hong Kong, Great Britain,
Austria and
France
PRODUCT GE OEC 9600 C-arm Fluoroscopy System,
CODE
Serial numbers: 69-1484, 69-3633,
69-3707, 69-1266-RC, 6C-0009-S, 62-0134, 69-1332, 69-3582, 69-3324, 69-2816,
62-0117, 69-2154, 65-0221, 69-2620, 69-2556, 69-0150, 69-3741, 62-0082, 62-0367,
62-0110-RC, 69-2574, 69-0313, 69-3774, 69-0108, 69-2878, 69-0195, 69-0028,
69-3580, 62-0473, 69-2035, 69-2881, 69-2775, 69-2234, 62-0261, 6S-0093-C,
69-2639-C, 69-2615, 69-2882, 62-0154, 69-1075, 69-1440, 6S-0044, 69-0357,
69-3130, 69-2699, 69-3876, 62-0086, 69-2716, 6S-0213, 69-2891, 62-0222, 69-2046,
69-2127, 69-2297, 69-2760, 69-2999-RC1, 69-3245, 6S-0137-C, 6S-0051C, 69-1022,
69-3026, 62-0087, 6S-0079-C, 69-0343, 62-0159, 69-0216, 62-0611, 69-2904,
69-3875, 69-3769, 6S-0199, 69-2767, 69-1087, 69-1401, 62-0239, 69-3519, 69-2592,
69-0282, 69-3776, 69-0436, 69-3145, 69-2320, 69-3577, 69-2621, 69-2553,
69-1188-RC, 69-0082, 6S-0228, 69-3833, 69-1009, 69-3668, 6S-0233, 69-0397,
69-2884, 69-1341, 69-0429, 69-3157, 69-0041, 69-3486, 69-1040, 69-2642, 62-0203,
69-3808, 69-0432, 69-3792, 62-0132, 62-0350, 69-2814, 65-0087-C, 6S-0086-C,
6S-0170, 66-0046, 69-0482, 69-2983, 69-335C, 69-2542, 69-2436-RC, 69-2634,
69-2879, 69-3866, 62-0481-C, 62-0600, 69-2916, 69-3368, 69-0304, 69-2781,
69-3409, 69-0243, 69-3258, 62-0100, 69-1348, 69-2222, 69-2126, 69-2293, 69-3512,
69-3888, 69-2545, 69-0094, 69-2873, 69-2870, 69-2874, 6S-0251, 69-3467-C,
69-2702, 69-1391, 69-3811, 6S-0156, 6S-0063, 69-1461, 69-3260, 69-3716, 69-3084,
69-2539, 69-3907, 62-0127, 6C-0042-RF, 69-3113, 69-3766, 69-0479, 62-0365,
69-2227, 69-3835-RC, 69-0066, 6S-0283, 69-1306, 69-2562, 69-1001, 69-1437,
69-3202, 69-0119, 69-2617, 6C-0017-RC, 69-1020, 69-2263, 69-0086, 69-3397,
62-0347, 69-0042, 62-0429, 69-3476, 69-0452, 69-0382, 6C-0015, 62-0126, 62-0596,
69-1454, 69-0360-RC, 69-2913, 69-1416, 69-2567, 69-2675, 62-0051, 69-2885,
6S-0197, 69-2268, 69-2269, 69-0068, 69-3232, 69-2348, 69-3312, 69-2611-C,
69-2591, 69-3837, 69-3618, 69-0130, 69-2405, 62-0604, 69-2828, 69-0289, 69-3740,
69-1227, 69-2968, 69-0135, 69-2654-C, 69-2941, 69-2142, 62-0054, 69-3705,
6S-0217, 69-1189, 69-2271, 69-0093, 6S-0301, 69-2521, 69-0205-RC, 69-2706,
69-3481, 69-2031, 62-0223, 69-1280, 69-1427-RC, 69-2773-RC, 6S-0128, 69-2725,
69-3804, 69-1472-RC, 69-0098, 69-3162, 69-0156, 62-0468, 69-3899, 69-2684,
69-0414, 69-1508, 69-0283, 69-2299-RC, 69-2079, 69-3654, 69-1413, 69-2285,
62-0560, 69-0183, 69-1027-RM, 62-0337, 69-0026, 69-3755, 69-3856, 69-2748,
69-2746, 65-0297, 69-3821, 69-2533, 69-3585, 69-3564, 69-2756, 69-0021, 69-2616,
69-1411, 69-0384, 69-3191, 69-3639-RC, 69-1011, 69-3807, 69-3470, 69-1173,
69-3253, 69-3541, 69-2623, 69-2625-C, 69-2758, 62-0073, 69-0081, 6S-0208,
6S-0209-C, 69-0020, 69-1486, 69-3640, 6S-0141, 69-2061-RC, 6S-0144, 69-3719,
69-2479, 69-3361, 69-2792, 62-0274, 69-2368, 69-2059, 69-2963-RC, 6S-0161-C,
69-1324, 69-1433, 69-2548, 69-3438, 62-0155, 62-0377, 6S-0184-C, 62-0016,
69-2589, 62-0340, 62-0040, 6S-0101-C, 69-2194, 69-2024, 69-3077, 69-0427,
69-3190, 69-0097, 69-2581, 69-2550, 69-3608, 6S-0114, 69-0402, 62-0081, 69-1405,
6S-0250, 69-3032, 69-1449, 69-2583, 69-2544, 69-1383, 6S,0106, 69-2053, 6S-0050,
69-2391, 69-3878, 69-0474, 69-3902, 69-1404, 69-2943, 69-0060, 6S-0055-C-RC,
62-0092, 69-2549, 62-0441, 62-0161, 69-3223, 69-3212, 69-1006, 62-0108, 69-3471,
6S-0256, 69-1496, 69-2025, 6S-0004, 69-3686, 69-3388, 69-1032, 69-3053, 69-3441,
62-0068, 69-1386, 69-3905, 69-2596-C, 69-2338, 69-2115, 69-0337, 69-2034,
69-2686, 69-3429, 69-2764, 62-0385, 69-3777-RC, 69-3088, 69-2701, 69-3767,
62-0474, 69-2692, 69-2555, 6S-0002, 6S-0133, 69-0234, 69-2375, 6C-0004, 69-0100,
69-3612, 69-0172, 69-3183, 69-2597-C, 69-0027, 69-1264, 62-0076, 6C-0005,
69-2441, 62-0047, 62-0136, 69-1334, 69-2413, 69-3198, 69-3259, 69-2323, 69-1392,
69-3657, 69-3825, 69-1441, 62-0085, 69-2033, 62-0578, 69-2653-C, 69-0386,
62-0069, 69-2783, 69-1381, 6S-0131, 62-0160, 69-3841, 69-2543, 69-2485, 69-1477,
69-2278, 69-3242, 69-0069, 69-2827-RC, 69-3733-RC, 69-2203, 69-0087, 62-0518,
69-1473, 69-3854, 69-1042, 69-0101, 69-0139, 69-0155, 69-0453, 6S-0132, 69-2613,
69-2851, 6S-0181, 6S-0082-C, 62-0496, 69-1390, 69-3892, 69-3166, 69-2063,
69-3020, 6S-0061-RC, 6C-0023-RC, and 6S-0187
RECALLING
FIRM/MANUFACTURER OEC Medical Systems, Inc., Salt Lake City, UT
REASON
Secondary collimator filters may be
missing on certain x-ray units. It was discovered that the secondary collimator
filter on some OEC 9600 C-arms was omitted when a collimator assembly was
replaced. This would reduce the filtration and therefore the Half-Value-Layer (HVL) of the X-ray beam, and may result in non-compliance with respect to
Maximum Entrance Exposure Rate (EER) unless the maximum EER verification and/or
calibration were performed after collimator replacement.
VOLUME OF
PRODUCT IN COMMERCE 700
units
DISTRIBUTION Nationwide
PRODUCT
a) Arnot-Ogden Med Ctr Hip Pack, REF: K12T-02160A, Sterile. A combination of
legally marketed medical devices placed into one container for the
convenience of the user and used within the limits of the products' intended
uses,
b) Arnot-Ogden Med Ctr Hip Pack, REF:
K12T-02159A, Sterile. A combination of legally marketed medical devices
placed into one container for the convenience of the user and used within
the limits of the products' intended uses,
CODE
a) Lot: V477096;
b) Lot:
V477095
RECALLING FIRM/MANUFACTURER
Recalling Firm: Merit
Medical Systems, Inc., South Jordan, UT,
Manufacturer: Zimmer, Inc., Warsaw, IN.
REASON
Sterility Compromised: Component of
convenience kit was recalled by its manufacturer for
non-sterility.
VOLUME OF PRODUCT IN COMMERCE 60
kits
DISTRIBUTION Nationwide
PRODUCT GE Healthcare Definium 8000 Digital Radiographic System. Formerly GE
Healthcare Revolution XR/d with Tomosynthesis,
CODE
00000002047M39, 00000005487M34,
00000096986DP%, 00000100740WK6, 00000TA41882-7, 00000TA41972-3, 00000TA41984-4,
00000TA41984-6, 00000TA42274-8, 00000TA42869-6, 00001004330WK5, 00001004332WK1,
00001004504WK5, 00001004505WK2, 00001004510WK2, 00001004513WK6, 00001004764WK5,
00001004765WK2, 00001004766WK0, 00001004768WK6, 00001004770WK2, 00001004772WK8,
00001005020WK1, 00001005022WK7, 00001005024WK3, 00001005030WK0, 00001005031WK8,
00001005035WK9, 00001005181WK1, 00001005182WK9, 00001005188WK6, 00001005260WK3,
00001005339WK5, 00001005758WK6, 00001005914WK5, 00001006042WK4, 00001006474WK9,
00001006635WK5, 00001006637WK1, 00001006638WK9, 00001006668WK6, 00001006871WK6,
00001007161WK1, 00001007166WK0, 00001007403WK7, 00001007404WK5, 00001007480WK5,
00001007536WK4, 00001007644WK6, 00001007650WK3, 00001007907WK7, 00001008312WK9,
00001008314WK5, 00001008497WK8, 00001008684WK1, 00001008807WK8, 00001008813WK6,
00001009140WK3, 00001009143WK7, 00001009145WK2, 00001009216WK1, 00001009268WK2,
00001009375WK5, 00001009380WK5, 00001009382WK1, 00001009709WK5, 00001009818WK4,
00001009875WK4, 00001009934WK9, 00001009976WK0, 00001010085WK7, 00001010099WK8,
00001010161WK6, 00001010239WK0, 00001010294WK5, 00001010295WK2, 00001010297WK8,
00001010431WK3, 00001010488WK3, 00001010524WK5, 00001010628WK4, 00001010629WK2,
00001010687WK0, 00001010693WK8, 00001010695WK3, 00001010906WK4, 00001010907WK2,
00001010964WK3, 00001011084WK9, 00001011085WK6, 00001011092WK2, 00001011215WK9,
00001011285WK2, 00001011289WK4, 00001011386WK8, 00001011455WK1, 00001011488WK2,
00001011490WK8, 00001011647WK3, 00001011654WK9, 00001011700WK0, 00001011712WK5,
00001011822WK2, 00001011825WK5, 00001011827WK1, 00001011828WK9, 00001011829WK7,
00001011832WK1, 00001012012WK9, 00001012119WK2, 00001012286WK9, 00001012449WK3,
00001012450WK1, 00001012453WK5, 00001012923WK7, 00001013064WK9, 00001013067WK2,
00001013100WK1, 00001013101WK9, 00001013134WK0, 00001013136WK5, 00001013223WK1,
00001013334WK6, 00001013336WK1, 00001013622WK4, 00001014310WK5, 00001014936WK7,
00001016147WK9
RECALLING FIRM/MANUFACTURER GE Healthcare,
Waukesha, WI,
REASON Loss of image data: Software anomaly in
the Processing Software on the Definium 8000 system may impact patient safety
when using the VolumeRAD advanced application (option). The slice visualization
of VolumeRAD exams acquired on the wallstand receptor will be offset by 17mm.
This prevents the visualization of anatomy WITHIN a distance of 17mm from the
wallstand patient barrier (receptor cover). This lost anatomy cannot be
recovered or visualized by retrospective reconstruction
processing.
VOLUME OF PRODUCT IN COMMERCE 127
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT GE Healthcare Definium 8000 Digital Radiographic System,
CODE
0000000002772E, 00000001191M36,
00000001561M30, 00000001895M32, 00000002041M32, 00000002051M31, 00000002052M39,
00000002065M31, 00000002364M38, 00000002439M38, 00000002441M34, 00000002650M30,
00000002767EN2, 00000002771M34, 00000002968M36, 00000003468M36, 00000003505M35,
00000003806M37, 00000004101M32, 00000004105M33, 00000004199M36, 00000004442M30,
00000096383DP5, 00000096401DP5, 00000097412DP1, 00000097656DP3, 00000097918DP7,
00000114134VE0, 00000114297VE5, 00000114452VE6, 00000TA41711-6, 00000TA41732-3,
00000TA41827-4, 00000TA41867-8, 00000TA41882-7, 00000TA41896Ë4, 00000TA41972-3,
00000TA41984-4, 00000TA41984-6, 00000TA41995-7, 00000TA42004Ë5, 00000TA42007-4,
00000TA42020-3, 00000TA42025Ë4, 00000TA42274-8, 00000TA42869-6, 00001003925WK3,
00001003974WK1, 00001004022WK8, 00001004138WK2, 00001004163WK0, 00001004319WK8,
00001004331WK3, 00001004508WK6, 00001004509WK4, 00001004512WK8, 00001004763WK7,
00001004767WK8, 00001004769WK4, 00001004771WK0, 00001005016WK9, 00001005017WK7,
00001005018WK5, 00001005019WK3, 00001005021WK9, 00001005023WK5, 00001005025WK0,
00001005026WK8, 00001005027WK6, 00001005029WK2, 00001005032WK6, 00001005033WK4,
00001005034WK2, 00001005179WK5, 00001005180WK3, 00001005183WK7, 00001005184WK5,
00001005185WK2, 00001005186WK0, 00001005187WK8, 00001005319WK7, 00001005669WK5,
00001005698WK4, 00001005699WK2, 00001005701WK6, 00001005702WK4, 00001005705WK7,
00001005706WK5, 00001005707WK3, 00001005755WK2, 00001005757WK8, 00001005759WK4,
00001005761WK0, 00001005762WK8, 00001005763WK6, 00001005764WK4, 00001005841WK0,
00001005911WK1, 00001005912WK9, 00001005913WK7, 00001005915WK2, 00001006015WK0,
00001006040WK8, 00001006041WK6, 00001006043WK2, 00001006044WK0, 00001006177WK8,
00001006178WK6, 00001006179WK4, 00001006469WK9, 00001006470WK7, 00001006471WK5,
00001006475WK6, 00001006476WK4, 00001006477WK2, 00001006478WK0, 00001006631WK4,
00001006633WK0, 00001006634WK8, 00001006664WK5, 00001006665WK2, 00001006666WK0,
00001006667WK8, 00001006822WK9, 00001006833WK6, 00001006834WK4, 00001006872WK4,
00001006873WK2, 00001006874WK0, 00001006875WK7, 00001006876WK5, 00001006877WK3,
00001006878WK1, 00001006880WK7, 00001007160WK3, 00001007162WK9, 00001007163WK7,
00001007164WK5, 00001007165WK2, 00001007167WK8, 00001007168WK6, 00001007169WK4,
00001007188WK4, 00001007189WK2, 00001007190WK0, 00001007191WK8, 00001007192WK6,
00001007405WK2, 00001007406WK0, 00001007407WK8, 00001007409WK4, 00001007476WK3,
00001007477WK1, 00001007478WK9, 00001007497WK9, 00001007498WK7, 00001007499WK5,
00001007516WK6, 00001007517WK4, 00001007518WK2, 00001007525WK7, 00001007527WK3,
00001007528WK1, 00001007529WK9, 00001007530WK7, 00001007531WK5, 00001007532WK3,
00001007533WK1, 00001007534WK9, 00001007535WK6, 00001007536WK4, 00001007642WK0,
00001007643WK8, 00001007645WK3, 00001007646WK1, 00001007647WK9, 00001007649WK5,
00001007651WK1, 00001007713WK9, 00001007715WK4, 00001007716WK2, 00001007717WK0,
00001007718WK8, 00001007719WK6, 00001007720WK4, 00001007721WK2, 00001007776WK6,
00001007777WK4, 00001007778WK2, 00001007779WK0, 00001007779WK0, 00001007780WK8,
00001007781WK6, 00001007782WK4, 00001007783WK2, 00001007784WK0, 00001007785WK7,
00001007786WK5, 00001007787WK3, 00001007788WK1, 00001007903WK6, 00001007904WK4,
00001007905WK1, 00001007906WK9, 00001007908WK5, 00001007909WK3, 00001007910WK1,
00001007911WK9, 00001007912WK7, 00001008307WK9, 00001008308WK7, 00001008309WK5,
00001008311WK1, 00001008313WK7, 00001008315WK2, 00001008316WK0, 00001008498WK6,
00001008499WK4, 00001008500WK9, 00001008501WK7, 00001008682WK5, 00001008685WK8,
00001008686WK6, 00001008687WK4, 00001008688WK2, 00001008689WK0, 00001008690WK8,
00001008691WK6, 00001008807WK8, 00001008808WK6, 00001008809WK4, 00001008810WK2,
00001008811WK0, 00001008812WK8, 00001008814WK4, 00001008816WK9, 00001008835WK9,
00001008837WK5, 00001008838WK3, 00001008839WK1, 00001008840WK9, 00001008841WK7,
00001008842WK5, 00001008843WK3, 00001008995WK1, 00001009057WK9, 00001009058WK7,
00001009059WK5, 00001009060WK3, 00001009061WK1, 00001009062WK9, 00001009063WK7,
00001009064WK5, 00001009065WK2, 00001009066WK0, 00001009141WK1, 00001009142WK9,
00001009144WK5, 00001009146WK0, 00001009147WK8, 00001009213WK8, 00001009215WK3,
00001009216WK1, 00001009217WK9, 00001009218WK7, 00001009219WK5, 00001009220WK3,
00001009221WK1, 00001009222WK9, 00001009252WK6, 00001009264WK1, 00001009265WK8,
00001009267WK4, 00001009268WK2, 00001009269WK0, 00001009270WK8, 00001009271WK6,
00001009273WK2, 00001009373WK0, 00001009374WK8, 00001009376WK3, 00001009377WK1,
00001009378WK9, 00001009381WK3, 00001009528WK9, 00001009529WK7, 00001009530WK5,
00001009532WK1, 00001009533WK9, 00001009534WK7, 00001009536WK2, 00001009537WK0,
00001009592WK5, 00001009593WK3, 00001009601WK4, 00001009602WK2, 00001009603WK0,
00001009604WK8, 00001009605WK5, 00001009606WK3, 00001009607WK1, 00001009609WK7,
00001009610WK5, 00001009707WK9, 00001009708WK7, 00001009710WK3, 00001009712WK9,
00001009713WK7, 00001009714WK5, 00001009716WK0, 00001009816WK8, 00001009817WK6,
00001009819WK2, 00001009821WK8, 00001009822WK6, 00001009823WK4, 00001009824WK2,
00001009873WK9, 00001009875WK4, 00001009876WK2, 00001009929WK9, 00001009930WK7,
00001009931WK5, 00001009933WK1, 00001009938WK0, 00001009977WK8, 00001009979WK4,
00001009981WK0, 00001009983WK6, 00001009984WK4, 00001009985WK1, 00001010085WK7,
00001010086WK5, 00001010098WK0, 00001010100WK4, 00001010101WK2, 00001010102WK0,
00001010103WK8, 00001010106WK1, 00001010107WK9, 00001010157WK4, 00001010158WK2,
00001010159WK0, 00001010160WK8, 00001010162WK4, 00001010167WK3, 00001010169WK9,
00001010170WK7, 00001010171WK5, 00001010238WK2, 00001010239WK0, 00001010240WK8,
00001010241WK6, 00001010242WK4, 00001010243WK2, 00001010291WK1, 00001010293WK7,
00001010296WK0, 00001010298WK6, 00001010299WK4, 00001010300WK0, 00001010348WK9,
00001010349WK7, 00001010350WK5, 00001010351WK3, 00001010354WK7, 00001010356WK2,
00001010357WK0, 00001010432WK1, 00001010433WK9, 00001010489WK1, 00001010490WK9,
00001010491WK7, 00001010493WK3, 00001010521WK1, 00001010523WK7, 00001010526WK0,
00001010527WK8, 00001010528WK6, 00001010529WK4, 00001010530WK2, 00001010625WK0,
00001010626WK8, 00001010627WK6, 00001010628WK4, 00001010630WK0, 00001010631WK8,
00001010632WK6, 00001010633WK4, 00001010693WK8, 00001010694WK6, 00001010696WK1,
00001010697WK9, 00001010698WK7, 00001010721WK7, 00001010723WK3, 00001010786WK0,
00001010804WK1, 00001010805WK8, 00001010806WK6, 00001010807WK4, 00001010808WK2,
00001010902WK3, 00001010904WK9, 00001010905WK6, 00001010911WK4, 00001010960WK1,
00001010962WK7, 00001010967WK6, 00001011022WK9, 00001011079WK9, 00001011080WK7,
00001011081WK5, 00001011082WK3, 00001011085WK6, 00001011086WK4, 00001011087WK2,
00001011088WK0, 00001011090WK6, 00001011091WK4, 00001011210WK0, 00001011211WK8,
00001011212WK6, 00001011213WK4, 00001011214WK2, 00001011216WK7, 00001011218WK3,
00001011283WK7, 00001011284WK5, 00001011286WK0, 00001011287WK8, 00001011288WK6,
00001011290WK2, 00001011291WK0, 00001011292WK8, 00001011330WK6, 00001011380WK1,
00001011382WK7, 00001011383WK5, 00001011385WK0, 00001011386WK8, 00001011387WK6,
00001011389WK2, 00001011449WK4, 00001011450WK2, 00001011700WK0, 00001011703WK4,
00001011712WK5, 00001012286WK9, 00001012453WK5, 00001013134WK0, 00001014310WK5,
00001014936WK7, 00001016147WK9
RECALLING
FIRM/MANUFACTURER GE Healthcare, Waukesha, WI,
REASON
Radiation dose reading greater than
actual dose: Error in the generator software on the GE Healthcare Revolution XR/d configured with HP 8200 PC consoles and all Definium 8000 systems may
impact patient safety. Occasional generator software errors may cause light
X-ray Images with reported mAs readings higher than was actually exposed to the
patient using the overhead X-ray tube. The mAs readings reported from the system
could be up to ten times higher than what was actually exposed to the patient.
Occurrence is limited to the first exposure after the focal spot is switched
from small to large. The generator incorrectly applies the small filament limit
to the large focal spot, which can cause the large focal spot to produce less
current. Subsequent large focal spot exposures will not exhibit this
issue.
VOLUME OF PRODUCT IN COMMERCE 454
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT IsoMed Refill Kit, Model 8553, is intended for use in refilling Medtronic
IsoMed pumps. Contents: Two 22-gauge needles, extension tubing set with
y-connector and clamp, Filter, 10-ml syringe, 60-ml lidded syringe, Fenestrated
drape, Template; Product is packaged in a sterile container,
CODE
Lot 60538731, Use by Date is May 10,
2009
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtronic Neuromodulation, Minneapolis, MN,
Manufacturer: B. Braun Medical, Inc.,
Allentown, PA. REASON Medtronic is retrieving all unused
packages of ISOMED Refill Kit Model 8553, Lot 60538731. This lot of product was
released using incorrect endotoxin specification limits. Endotoxin contamination
can potentially lead to fever, malaise, respiratory distress, septic shock, and
death.
VOLUME OF PRODUCT IN COMMERCE 1,982
units
DISTRIBUTION Nationwide, Argentina, Australia, and
Hong Kong
PRODUCT CyberKnife Robotic Radiosurgery System radiation therapy device with
Multiplan treatment Planning Software versions 1.5.2 and higher,
CODE
Versions 1.5.2, with system numbers (all
preceded by C0) 095, 142, 058, 106, 061, 056, 128, 129, 079, 088, 116, 151, 139,
047, 070, 072, 133, 112, 149, 078, 137, 025, 098, 092, 045, 144, 124, 160, 044,
126, 123, 111, 055, 062, 074, 068, 059, 052, 103, 132, 100, 150, 051, 094, 119,
034, 146, 153, 064, 155, 037, 114, 046, 063, 097, 143, 067, 131, 042, 048, 090,
091, 122, 159, 022, 109, 099, 135, 036, 134, 127, 158, 057, 069, 030, 118, 108,
152, 136, 049, 102, 080, 101, 141, 071, 087, 140, 107, 145, 148, 120, 023, 147,
089, 038, 041, 065, 138, 060, 113, 110, 130, 043, 125, 105, 093, 117, 032,
066
RECALLING FIRM/MANUFACTURER Accuray, Inc., Sunnyvale,
CA,
REASON Sample beam data (which should not be
used to treat patients) may differ from actual radiation output of an installed
product, and which may be used by users.
VOLUME OF PRODUCT IN
COMMERCE 109 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw Size (diameter
x length) 5 x 30mm, Non-winged, Catalog # LG-PR0530,
b) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 5 x 35mm, Non-winged, Catalog # LG-PR0535,
c) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 5 x 45mm, Non-winged, Catalog # LG-PR0545,
d) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 6 x 30mm, Non-winged, Catalog # LG-PR0630,
e) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 6 x 35mm, Non-winged, Catalog # LG-PR0635,
f) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 6 x 40mm, Non-winged, Catalog # LG-PR0640,
g) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 6 x 50mm, Non-winged, Catalog # LG-PR0650,
h) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 7 x 35mm, Non-winged, Catalog # LG-PR0735 and Screw
Size (diameter x
length) 7 x 50mm, Non-winged, Catalog # LG-PR0750, i) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 7 x 40mm, Non-winged, Catalog # LG-PR0740,
j) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 7 x 45mm, Non-winged, Catalog # LG-PR0745,
k) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 5 x 35mm, Winged, Catalog # LG-PW0535;
l) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 5 x 40mm, Winged, Catalog # LG-PW0540,
m) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 5 x 45mm, Winged, Catalog # LG-PW0545,
n) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 6 x 35mm, Winged, Catalog # LG-PW0635 and Screw
Size (diameter x length) 6 x 55mm, Winged, Catalog # LG-PW0655,
o) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 6 x 40mm, Winged, Catalog # LG-PW0640,
p) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 6 x 45mm, Winged, Catalog # LG-PW0645,
q) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 7 x 35mm, Winged, Catalog # LG-PW0735,
r) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 7 x 40mm, Winged, Catalog # LG-PW0740,
s) Allez Spine Laguna Pedicle Screw System, Non-Conical Screw
Size (diameter x length) 7 x 45mm, Winged, Catalog # LG-PW0745,
CODE
Catalog # only
RECALLING
FIRM/MANUFACTURER Allez Spine, LLC, Irvine, CA,
REASON
This recall was initiated after Internal
Engineering Testing of the conical seat design pedicle screws of sizes 5, 6 and
7 showed a potential of partial displacement of screw shank when used in
combination with the single piece locking nuts. This partial displacement of the
screw shank could finally lead to total separation and failure of the
construct.
VOLUME OF PRODUCT IN COMMERCE 625
units
DISTRIBUTION AZ, CA, CO and
UT
PRODUCT Osteonics Scorpio Total Knee; Posteriorly Stabilized Femoral Component; # 13
with posts, low friction lon treatment. Use only with Scorpio Posteriorly
Stabilized Tibial Bearing Components with Scorpio Patellar Components, Catalog
No. 711-4513L,
CODE Lot:
K04S174
RECALLING FIRM/MANUFACTURER Stryker Howmedica
Osteonics Corp., Mahwah, NJ,
REASON Component labeled and laser marked as
a Left, was in fact a Right component.
VOLUME OF PRODUCT IN
COMMERCE 1
unit
DISTRIBUTION Internationally
PRODUCT Hoffman II compact Sterile Wrist Kit is used in the stabilization of open
and unstable fractures; Catalog Number: 4940-9-810,
CODE
Lot Codes: H11883, H13813, H17174,
H18891, K01047, K03042, K05896
RECALLING
FIRM/MANUFACTURER Stryker Howmedica Osteonics Corp., Mahwah, NJ,
REASON
The pin of the Hoffmann II Compact
External Fixation System may jam into the Soft Tissue
protector.
VOLUME OF PRODUCT IN COMMERCE 105
kits
DISTRIBUTION Nationwide
PRODUCT VariSource®
CT/MR Ring & Tandem Applicator Set, catalog # AL13017000,
containing 32mm titanium ring applicators, each identified as part numbers
AL07362000, AL07363000, and AL07364000,
CODE All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems, Inc.,
Charlottesville, VA,
Manufacturer: Varian
Medical Systems U.K. Ltd., Crawley, United Kingdom.
REASON
Medical device may exhibit inaccurate
positioning and lead to unintended dose delivery during brachytherapy
treatment.
VOLUME OF PRODUCT IN COMMERCE 120
units
DISTRIBUTION Nationwide
PRODUCT
a) TRIGEN Hind Foot Fusion Nail, 10mm X 25mm Left, REF 71701025L. The device
is indicated for degeneration, deformity, or trauma of both the tibiotalar
and
talocalcaneal articulations in the hindfoot,
b)
Hind Foot Fusion Nail, 11.5mm X 25mm Left, REF 71701125L. The device is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot,
c)
TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Left, REF 71701120L. The device
is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot,
d)
TRIGEN Hind Foot Fusion Nail, 10mm X 20mm Left, REF 71701020L. The device is
indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot,
e)
TRIGEN Hind Foot Fusion Nail, 10mm X 16mm Left, REF 71701016L. The device is
indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot,
f)
TRIGEN Hind Foot Fusion Nail, 11.5mm X 20mm Right, REF 71701120R. The device
is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot,
g)
TRIGEN Hind Foot Fusion Nail, 11.5mm X 25mm Right, REF 71701125R. The device
is indicated for degeneration, deformity, or trauma of both the tibiotalar and
talocalcaneal articulations in the hindfoot,
CODE
a) Lot No. 07FM16322, exp.
06/2017;
b) Lot Nos.: 07GM00339, exp. 07/2017; 07EM23987, exp. 05/2017;
07EM23988, exp. 05/2017; 07EM23990, exp. 05/2017; 07EM23989, exp.
05/2017;
c) Lot Nos.: 07GM00331, exp. 07/2017; 07EM19430, exp. 05/2017;
07EM19433, exp. 05/2017; 07EM19429, exp. 05/2017; 07EM19436, exp. 05/2017;
07EM19438,
exp. 05/2017;
d) Lot No. 07EM23985, exp. 05/2017;
e) Lot
Nos.: 07FM05443, exp. 06/2017; 07FM05447, exp. 06/2017; 07FM05444, exp.06/2017; 07FM05445, exp. 06/2017; 07FM05446, exp. 06/2017;
f) Lot Nos.:
07EM23986, exp. 05/2017; 07EM14998, exp. 05/2017; 07EM15191, exp.05/2017;
07EM15186, exp. 05/2017; 07EM15187, exp. 05/2017; 07EM15190, exp.
05/2017;
07EM15189, exp. 05/2017; 07EM11027, exp. 05/2017; 07EM11030, exp.05/2017;
07EM11033, exp. 05/2017; 07EM11052, exp. 05/2017; 07EM11048, exp.
05/2017;
07DM21935, exp. 04/2017; 07DM20072, exp. 04/2017; 07DM20074, exp.04/2017;
07DM21934, exp. 04/2017;
g) Lot Nos.: 07EM17278, exp. 05/2017; 07DM21938,
exp. 04/2017
RECALLING FIRM/MANUFACTURER Smith &
Nephew, Inc., Memphis, TN,
REASON One of the distal locking screw holes on
a hindfoot fusion nail was drilled with an incorrect
trajectory.
VOLUME OF PRODUCT IN COMMERCE 265
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT NexStent Monorail Carotid Stent System, Material number M 001553000, Catalog
number 55-300, packaged in a PET tray,
CODE
All products distributed between
04/07/2005 through 04/28/2006, Lot numbers (batch numbers are the same as lot
numbers, without preceding letter): c45301, c50101, c50202, c50203, c50204,
c50205, c50301, c50302, c50303, c50304, c50305, c50401, c50402, c50403, c50404,
c50405, c50406, c50501, c50502, c50503, c50601, c50602, c50701, c50702, c50703,
c50704, c50801, c50802, c50803, c50804, c50805, c50901, c50902, c50903, c50904,
c51001, c51002, c51003, c51101, c51102, c51201, c51202, c51301, c51302, c51303,
c51304, c51305, c51401, c51402, c51403, c51404, c51405, c51601, c51602, c51701,
c51702, c51801, c51802, c51803, c51804, c52101, c52201, c52202, c52203, c52401,
c52402, c52403, c52501, c52502, c52503, c52504, c52505, c52601, c52602, c52603,
c52701, c52702, c52703, c52704, c52801, c52802, c52901, c52902, c52903, c52904,
c53001, c53003, c53103, and c53801
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Cupertino,
Corp., Cupertino, CA,
Manufacturer: Boston Scientific Corp,
Natick, MA.
REASON Tip
may detach from stent delivery system.
VOLUME OF PRODUCT IN
COMMERCE 1,326
units
DISTRIBUTION Internationally
PRODUCT COAT-A-COUNT PSA IRMA kit (IKPS1, 2, 5, X). The device is intended as an aid
in monitoring patients for disease progress or response to therapy,
CODE
Lot Numbers: IKPS1 884 - 100 test size,
exp. 5/30/2008; IKPS2 864 - 200 test size, exp. 5/30/2008; IKPS5 862 - 500 test
size, exp. 5/30/2008; IKPSX 854 - 1000 test size, exp.
5/30/2008
RECALLING FIRM/MANUFACTURER Siemens Medical
Solutions Diagnostics, Los Angeles, CA,
REASON The Coat-A-Count
PSA IRMA kit (IKPS1, 2, 5, X) exhibits a low bias, which is evident when
comparing results with other methods, including the IMMULITE PSA kits.
Coat-A-Count PSA IRMA results are, for example, approximately 20% lower when
compared to results obtained with the IMMULITE 2000 Third Generation PSA assay
(L2KUP).
VOLUME OF PRODUCT IN COMMERCE 64
kits
DISTRIBUTION CA, FL, IL, IN, MD, MI, Bolivia, Chile,
Egypt, Cyprus, Korea, Phillippines, Taiwan,
Uruguay
PRODUCT
a)
Radiation therapy system - Coherence AG Therapist Part number 5863506 and Therapist system Part number 7339125, equipped with a Coherence Therapist
RTT2.1 or Primeview 3i R2.1. This is a medical charged particle radiation
therapy system, part of the firm's beam limiting device/accessory. The
product provides data
processing, and the SYNGO standard medical imaging
platform to provide comprehensive oncology workflow solutions for radiation
therapy,
b) Radiation therapy system - Coherence
Impression Therapist System equipped with a Coherence Therapist RTT2.1 or
Primeview 3i R2.1 part number 7341410. Medical charged particle Radiation
therapy system, part of the firm's beam limiting device/accessory. The
product provides data processing, and the SYNGO standard
medical imaging
platform to provide comprehensive oncology workflow solutions for radiation
therapy,
c) Radiation therapy system - PRIMEVIEW 3i
System equipped with a Coherence Therapist RTT2.1 or Primeview 3i R2.1, part
number 7341428. Medical charged
particle Radiation therapy system, part of
the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging
platform to provide
comprehensive oncology workflow solutions for radiation therapy,
d) Radiation therapy system - AG Therapist 3rd party V&R
equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number
7345411. Medical charged particle Radiation therapy system, part of the
firm's beam limiting device/accessory. The product provides data processing,
and the SYNGO standard medical imaging platform to provide comprehensive
oncology workflow solutions for radiation therapy,
e) Radiation therapy system - Impression Therapist 3rd party
V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part
number 7345429. Medical
charged particle Radiation therapy system, part of
the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy,
f) Radiation therapy system - Syngo Based WS for 3rd party
V&R equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part
number 7345437. Medical
charged particle Radiation therapy system, part of
the firm's beam limiting device/accessory. The product provides data
processing, and the SYNGO standard medical imaging platform to provide
comprehensive oncology workflow solutions for radiation therapy,
g) Radiation therapy system - Coherence Therapist 2.0 equipped
with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139839.
Medical charged particle Radiation therapy system, part of the firm's beam
limiting device/accessory. The product provides data processing, and the
SYNGO standard medical imaging platform to provide comprehensive oncology
workflow solutions for radiation therapy,
h)
Radiation therapy system - PRIMEVIEW 3i System 2.0 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8139847. Medical charged
particle Radiation therapy system, part of the firm's beam limiting
device/accessory. The product provides data processing, and the SYNGO
standard medical imaging platform to provide comprehensive oncology workflow
solutions for radiation therapy,
i) Radiation
therapy system - Coherence Therapist System 2.1 equipped with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147667. Medical charged
particle Radiation therapy system, part of the firm's beam limiting
device/accessory. The product provides data processing, and the SYNGO
standard medical imaging
platform to provide comprehensive oncology workflow
solutions for radiation therapy. Applies only to those parts used with the
following devices identified in the product
descriptions,
j) Radiation therapy system - PRIMEVIEW 3i System 2.1 equipped
with Coherence Therapist RTT2.1 or Primeview 3i R2.1, part number 8147675.
Medical charged particle Radiation therapy system, part of the firm's beam
limiting device/accessory. The product provides data processing, and the
SYNGO standard medical imaging platform to provide comprehensive oncology
workflow solutions for radiation therapy. Medical Linear accelerators
equipped with Coherence Therapist RTT2.1 or Primeview
3i R2.1 Software
Numbers 8146503, 8149119, and 8163318. Applies only to those parts used with
the following devices identified in the product descriptions,
CODE
Software Numbers 8146503, 8149119, and
8163318. Applies only to those parts used with the devices identified in the
product descriptions.
RECALLING FIRM/MANUFACTURER Siemens
Medical Solutions USA, Inc., Concord, CA,
REASON Software - Under
certain circumstances, the portal image may be overwritten, which may lead to
incorrect dosage.
VOLUME OF PRODUCT IN COMMERCE 491
units
DISTRIBUTION Distribution information pending from
firm.
PRODUCT
a)
GE 1.5T and 3.0T Signa® HDx MR System Model Numbers: 5127452, 2377062-61, and 2395001-2. Indicated for use as a diagnostic imaging device to produce
axial sagittal, coronal and oblique images, spectroscopic images, and/or
spectra, dynamic images of the internal structures and organs of the entire
body, including, but not
limited to, head, neck, TMJ, spine, breast, heart,
abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal
regions of the body,
b) GE Signa® Excite 1.5T MR
System, GE Signa® Excite 3.0T MR System. Model Numbers 5107849, 5107849-2,
M3000PT, and M3000PW. Indicated for use as a
diagnostic imaging device to
produce axial sagittal, coronal and oblique images, spectroscopic images,
and/or spectra, dynamic images of the internal structures and organs of the
entire body, including, but not limited to, head, neck, TMJ, spine, breast, heart, abdomen, pelvis, joints, prostate, blood vessels, and musculoskeletal
regions of
the body,
CODE
a)
00000HDMR20228 00000276057MR7 00000275160MR0 000000HDMR2544 00000HDMR10417
00000HDMR10094 00000274383MR9 00000273832MR6 00000274385MR4 00000276073MR4
00000274359MR9 00000HDMR10273 00000273119MR8 00000DDDM10670 00000HDMR20073
00000HDMR10739 000000HDMR2451 000000HDMR2335 00000HDMR20189 000000HDMR1004
00000HDMR10489 00000HDMR10291 00000HDMR20151 00000HDMR20061 00000HDMR10743
000000HDMR2528 000000HDMR2976 00000HDMR20044 000000HDMR2773 00000HDMR20294
00000HDMR20059 00000HDMR10418 00000HDMR10831 00000HDMR20036 00000HDMR20056 Model
No. 2377062-61 00000008376YR6 00000007126YR6 00000007551YR5 00000007555YR6
00000006690YR2 00000007518YR4 00000008525YR8 00000005222YR5 00000007134YR0
00000008354YR3 00000005989YR9 00000007107YR6 00000008100YR0 00000007594YR5
00000006710YR8 00000008103YR4 00000007092YR0 00000007503YR6 00000007574YR7
00000006754YR6 00000007542YR4 00000008116YR6 00000008522YR5 00000006685YR2
00000007105YR0 00000008564YR7 00000005974YR1 00000005545YR9 00000006705YR8
00000006600YR1 00000007585YR3 00000005532YR7 00000008549YR8 00000007533YR3
00000007498YR9 00000005231YR6 00000006583YR9 00000005216YR7 00000007554YR9
00000009031YR6 00000006708YR2 00000007117YR5 00000007864YR2 00000007866YR7
00000007514YR3 00000008342YR8 00000005546YR7 00000007892YR3 00000007865YR9
00000006556YR5 00000006660YR5 00000007862YR6 00000009421YR9 00000007556YR4
00000008378YR2 00000008539YR9 00000006656YR3 00000005536YR8 00000008115YR8
00000008335YR2 00000052299YR0 00000006727YR2 00000006726YR4 00000007572YR1 Model
No, 2395001-2 00000280673MR5 00000278397MR5 00000277211MR9 00000276434MR8
00000275968MR6 00000278549MR1 00000280781MR6 00000276265MR6 00000275046MR1
00000283745MR8 00000284233MR4 00000275648MR4 00000280000MR1 00000279068MR1
00000275967MR8 00000274744MR2 00000276266MR4 00000280001MR9 00000278851MR1
00000275647MR6 00000281340MR0 00000275465MR3 00000282549MR5
b)
00000262460MR9 00000270245MR4 00000260692MR9 00000269581MR5 00000268123MR7
00000277574MR0 00000267973MR6 00000280302MR1 00000262803MR0 00000270974MR9
00000273229MR5 00000277190MR5 00000277189MR7 00000279752MR0 00000261198MR6
00000272433MR4 00000269437MR0 00000265177MR6 00000264407MR8 00000265173MR5
00000274998MR4 00000268011MR4 00000270383MR3 00000262459MR1 00000269326MR5
00000261064MR0 00000271248MR7 00000263970MR6 00000276409MR0 00000274835MR8
00000278722MR4 00000271120MR8 00000262456MR7 00000273459MR8 00000266821MR8
00000266071MR0 00000276491MR8 00000266066MR0 00000265061MR2 00000266754MR1
00000271234MR7 00000266343MR3 00000273365MR7 00000262299MR1 00000263879MR9
00000262793MR3 00000273341MR8 00000266822MR6 00000269340MR6 00000273230MR3
00000262800MR6 00000261678MR7 00000271246MR1 00000280388MR0 00000261205MR9
00000262666MR1 00000262673MR7 00000260480MR9 00000276591MR5 00000279460MR0
00000272533MR1 00000263974MR8 00000262667MR9 00000261066MR5 00000271124MR0
00000277955MR1 2333 00000272072MR0 00000261069MR9 00000264087MR6 00000267322MR6
00000274839MR0 00000265005MR9 00000275642MR7 00000270466MR6 00000275086MR7
00000261061MR6 00000275845MR6 00000272076MR1 00000269435MR4 00000270387MR4
00000268518MR8 00000268477MR7 00000268515MR4 00000269575MR7 00000272968MR9
00000270026MR8 00000272969MR7 00000272070MR4 00000268692MR1 00000271662MR9
00000268417MR3 00000270467MR4 00000272536MR4 00000273529MR8 00000279146MR5
00000275668MR 00000260651MR5 Model No, 5107849-2 00000279077MR2 00000282686MR5
00000283386MR1 00000283076MR8 00000279423MR8 00000278623MR4 00000278626MR7
00000279921MR1 00000276633MR5 00000273541MR3 00000274170MR0 00000274930MR7
00000281703MR9 00000281443MR2 00000281019MR0 00000275936MR3 00000279713MR2
00000273267MR5 00000273266MR7 Model No. M3000PT 00000266842MR4 00000266160MR1
00000271322MR0 00000275009MR9 00000268302MR7 00000263655MR3 00000264783MR2
00000266194MR0 00000267528MR8 00000026005MR8 00000266156MR9 00000265852MR4
00000267533MR8 000267533MR8ZZ 00000265968MR8 00000267529MR6 00000267527MR0
00000266690MR7 00000264643MR8 00000267618MR7 00000268837MR2 00000270528MR3
00000270097MR9 00000268301MR9 00000269332MR3 00000267860MR5 Model No. M3000PW
00000266270MR8 00000250462MR9 00000263921MR9
RECALLING
FIRM/MANUFACTURER GE Medical Systems LLC, Waukesha, WI,
REASON A software issue that may result in
misregistration of functional and anatomical images associated with the 3.0T
BrainwaveRT fMRI Application on the 3.0T Signa HDx scanner.
VOLUME OF
PRODUCT IN COMMERCE 269
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Naviscan PET Systems, Inc ("Naviscan") PEM Flex Solo II PET Scanner. The PEM
Flex Solo II images small body parts with optimized PET technology,
CODE
Serial Numbers: P002-B-070316-01,
P002-B-070423-01, P002-B-070531-01, P002-B-070629-01, P002-B-070712-0l,
P002-B-070718-01, P002-B-070910-01, P002-B-070911-01, P002-B-071015-01,
P002-B-080107-01, P002-B-080108-01, P002-B-080207-01, and
P002-B-080307-01
RECALLING FIRM/MANUFACTURER Naviscan PET
Systems, San Diego, CA,
REASON This field correction is being initiated
as a result of the firm's investigation into a report from a user indicating
that the motorized compression exceeded 25 pounds of compression force during
the pre-scan positioning of the patient. The investigation identified that a
secondary fault protection did not perform as expected.
VOLUME OF
PRODUCT IN COMMERCE 13
units
DISTRIBUTION Nationwide
PRODUCT
Siemens brand Ultrasound Transducer 17L5HD used with ACUSON Sequoia
Ultrasound System; Model Number(s): 10035724, used with System Models: 08245875,
08246951, 08255412, 08255413, 08267697, 08269627, 10038241, 10038242, 10040724,
10040725, 10041008; Product is manufactured and distributed by The 17L5
transducer is intended for breast and small body parts imaging,
CODE
All lots
RECALLING
FIRM/MANUFACTURER Siemens Medical Solutions USA, Inc., Mountain
View, CA
REASON The product assembly can cause a failure
of the transducer which results in a double and/or overlapped image which may
ultimately result in misleading or false information, inability to accurately
diagnose, incorrect positioning/locating/insertion of the biopsy needle and/or
an interruption during the biopsy procedure.
VOLUME OF PRODUCT IN
COMMERCE 388 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
ARCHITECT c8000 Processing Module, for in vitro diagnostics; List Number
1G06-01 and 1G06-11, Affected software: v2.20, Part #7-201738-01; v2.20DB, Part
#7-201738-02; v2.60, Part #7-203715-01; v3.10, Part #7-203715-02; 3.11, Part
7-203715-03; and 3.12. The Abbott ARCHITECT cSystem is designed to perform
automated, random access, clinical chemistry analyzer which utilizes
spectrophotometry (monochromatic and bichromatic modes of measurement) for
photometric based determinations,
CODE Version 2.20, List #05F48-13; Version
2.20DB, List #05F48-14; Version 2.60, List #05F48-17; Version 3.10, List
#05F48-18; Version 3.11, List #05F48-20, and Version 3.12, List
#05F48-21
RECALLING FIRM/MANUFACTURER Abbott
Laboratories, Inc., Irving, TX,
REASON Software defect can allow tests
ordered for one sample to be aspirated from a different sample, reporting
erroneous results for the affected sample.
VOLUME OF PRODUCT IN
COMMERCE 2,378 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) Axis
Gamma Camera, Scintillation (gamma) camera. Model Numbers: 210714, 210880
and 211037 Part Numbers: 4535 665 13461, or N210714 Axis System,
3/8"
Crystals 4535 665 16601, or N210880 Axis System 3/4" Crystals 4535 665 12921, or N211037 Axis System 3/8 Precision 4535 665 13501, or N211039 Axis
System 3/4 Precision 4535 679 46301, or N211280 Axis System 3/8 Precision
4535 671 67421, or N211282 Axis System 3/4 Precision (Note: Due to a part
number
scheme change at the firm, either number is representative of the
identified system),
b) Irix Gamma Camera,
Scintillation (gamma) camera. Model Numbers: 210857 and 210881. 4535 679
46991, or N210857 Irix System, 3/8" Crystal 4535 665 13551, or
N210881 Irix
System 3/4" Crystals 4535 679 46981, or N211038 Irix System 3/8 Precision
4535 665 13571, or N211040 Irix System 3/4 Precision (Note: Due to a
part
number scheme change at the firm, either number is representative of the identified system),
c) Rotate Motion Shunt Resistor
Kit, Scintillation (gamma) camera,
CODE
a) and b) All units installed from
April 1, 2000 - November 30, 2007;
c) Lot Numbers: 4535 664 01241 and
N753360
RECALLING FIRM/MANUFACTURER Philips Medical
Systems (Cleveland), Inc., Cleveland, OH,
REASON Resistor Failure: The
Rotate Motion Shunt Resistor may overheat and results in the appearance of
smoke, a burning smell, and an electronic stop condition, which will disable the
gamma camera rotate motion and all other motions.
VOLUME OF PRODUCT
IN
COMMERCE Undetermined
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Harleco Brand Ethanol Standard, 1.0 mg/ml 1.0 mg Ethanol in 1 ml 10
ampules;
Each ampule contains approximately 1.1 ml to facilitate the removal of 1.0 ml,
Item number 68991/95,
CODE Lot
number 7285 Expiration Date: April 30, 2010.
RECALLING
FIRM/MANUFACTURER EMD Chemicals, Inc., Gibbstown, NJ,
REASON
EMD Chemicals received 1 customer
complaint regarding 2 ampules measuring 2.0 mg/ml found in a lot of 20 ampules
of 1.0 mg/ml Ethanol Standard.
VOLUME OF PRODUCT IN
COMMERCE 112 cases/10 ampules per
case
DISTRIBUTION Nationwide
PRODUCT Cholestech LDX High Sensitivity C-Reactive Protein
(hs-CRP) Test Cassette.
The Cholestech LDX high sensitivity C-Reactive Protein (hs-CRP) is an in vitro
diagnostic test for the quantitative determination of C-reactive protein in
whole blood or serum. Measurement of CRP is useful as an aid in the detection
and evaluation of infection, tissue injury, inflammatory disorders and
associated diseases. The test cassettes are for use with the LDX analyzer;
Catalog #12-807
CODE Lot #
C17-6434
RECALLING FIRM/MANUFACTURER Cholestech, Corp.,
Hayward, CA,
REASON Test results are high, outside of
control material upper limit specification . Results could be as high as
15%.
VOLUME OF PRODUCT IN COMMERCE 2,190
cassettes
DISTRIBUTION Nationwide
WEEK ENDING OCTOBER 11
PRODUCT NeoMedix Trabectome I/A
Console, Model Number 550014, surgical aspirator,
CODE Lot Number 061205-1; Serial Numbers: 10117, 10119, 10120,
10122, 10124, 100129, and 10133
RECALLING FIRM/MANUFACTURER Neomedix
Corp., Tustin, CA,
REASON Failure of irrigation flow: The pinch valve in a few
pumps may not consistently open to allow irrigation flow. In over 450 surgeries,
the firm confirmed one instance of a valve that did not open. The electrically
activated pinch valve in the NeoMedix Trabectome I/A pump activates irrigation
flow to the eye during Trabectome surgery.
VOLUME OF PRODUCT IN COMMERCE 7
units
DISTRIBUTION CA, HI, IA, NY and
PA
PRODUCT GE Healthcare OEC 9900
mobile fluoroscopic x-ray system,
CODE All
codes
RECALLING FIRM/MANUFACTURER OEC Medical Systems, Inc., Salt Lake
City, UT
REASON Possible overexposure: Failure to apply the entrance
exposure rate (EER) tube current limit calibration to the automatic exposure
rate (AER) control system when the anatomical profile mode is changed from the
default selection to another selection. Manual technique modes are not
affected.
VOLUME OF PRODUCT IN COMMERCE 710
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) GE
Healthcare Innova 3100 Digital Fluoroscopic Imaging System with Bolus Chasing option,
b) GE Healthcare Innova 4100 Digital
Fluoroscopic Imaging System with Bolus Chasing option,
CODE
a) 8613100, 77573841, 0910064009, 3018774100, 4103323100,
4103374100, 4103623100, 4105434100, 4438494100, 5138534100, 5703214100,
7083333100, 7278253100, 8019643100, 8595724100, 9408984100, 082416040017,
082416070004, 082416120006, 082416130013, 082416140003, 201541LAB2,
229228INNOV41V, 239436CATH1, 251435ICV5, 270688INN, 304255INNOVA, 304347INNOVA,
309691P3100, 310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 315448RM4,
315448RM5, 316268INNOVAA, 319338VA4100, 325670CATH, 334286BSP, 352333VASC,
352376SP, 352401CATH, 352401VASC, 378INV31, 407SPECIALS, 409899LAB3, 413447CATH,
414961INN4100, 416756INNOVA, 417269SCLD, 478633INOV, 502587LAB4, 508856OR41,
516562INNOVA4, 516663INNOVA2, 518525LAB1, 540953INNOVA, 561266IN31,
563421CATHLAB8, 573632CRA, 573761SMA, 573815BCR1, 574535IN41, 574647IN41,
6012884100SP1, 601553CL3, 602239LAB4, 602239LAB6, 603778ECL1, 606833INNOVA,
614293LIBERTY1, 614293LIBERTY2, 615338CV2, 615769SKYCV2, 619340VA8,
619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 626359INNOVA, 702616INNOVA,
7028803100A, 706774CCL5, 713794LAB7, 713794LAB9, 715369INN4100, 717217INN31,
717763INNOVA41, 717763OR4100, 718283INNOVA3, 718518CVL1, 724656ANG, 724773C1,
727725SPEC1, 731422CV1, 732294INOV, 757398INNOVA, 757736INNOVA, 765453INNOVA1,
770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 803329CL41, 804594CATH,
808547QCV2A, 812238LIB1, 812279INNOVA1, 812283IN31, 812450EP1, 812482INNOVA,
813972INTV, 816276SP1, 817255NH4100, 817433HSW3100, 83INNOVA1188379, 845365V19,
850678IN3100, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904202CATH3,
904276SP, 908522LAB1, 909788INNOVA1, 918307SHIN4, 918744JC4100, 928779INNOVA1,
936266CL1, 956389INN31, 956632INN4100, 956994INN1, 956994INN2, 972487ANGIO1,
973971LAB3, BPINNOVA2, BPINNOVA3R, BPINNOVA3R, ECXV1406C, FHORLCL1, HC1536XR04,
RU1550VA01, RU2457VA01, SLIN4100, YV0022, and YV0036;
b) 8613100, 77573841, 0910064009, 3018774100, 4103323100, 4103374100,
4103623100, 4105434100, 4438494100, 5138534100, 5703214100, 7083333100,
7278253100, 8019643100, 8595724100, 9408984100, 082416040017, 082416070004,
082416120006, 082416130013, 082416140003, 201541LAB2, 229228INNOV41V,
239436CATH1, 251435ICV5, 270688INN, 304255INNOVA, 304347INNOVA, 309691P3100,
310423INNOVA1, 313593IC1, 313593IC2, 314525SACL2, 315448RM4, 315448RM5,
316268INNOVAA, 319338VA4100, 325670CATH, 334286BSP, 352333VASC, 352376SP,
352401CATH, 352401VASC, 378INV31, 407SPECIALS, 409899LAB3, 413447CATH,
414961INN4100, 416756INNOVA, 417269SCLD, 478633INOV, 502587LAB4, 508856OR41,
516562INNOVA4, 516663INNOVA2, 518525LAB1, 540953INNOVA, 561266IN31,
563421CATHLAB8, 573632CRA, 573761SMA, 573815BCR1, 574535IN41, 574647IN41,
6012884100SP1, 601553CL3, 602239LAB4, 602239LAB6, 603778ECL1, 606833INNOVA,
614293LIBERTY1, 614293LIBERTY2, 615338CV2, 615769SKYCV2, 619340VA8,
619482INNOVA1, 619541INNOVA31, 619552INNOVA1, 626359INNOVA, 702616INNOVA,
7028803100A, 706774CCL5, 713794LAB7, 713794LAB9, 715369INN4100, 717217INN31,
717763INNOVA41, 717763OR4100, 718283INNOVA3, 718518CVL1, 724656ANG, 724773C1,
727725SPEC1, 731422CV1, 732294INOV, 757398INNOVA, 757736INNOVA, 765453INNOVA1,
770991CL3, 773792CL3100, 773NORWG3100, 803329CL31, 803329CL41, 804594CATH,
808547QCV2A, 812238LIB1, 812279INNOVA1, 812283IN31, 812450EP1, 812482INNOVA,
813972INTV, 816276SP1, 817255NH4100, 817433HSW3100, 83INNOVA1188379, 845365V19,
850678IN3100, 865541CCL5, 865693CCL3, 901726SP2, 903CSM4100, 904202CATH3,
904276SP, 908522LAB1, 909788INNOVA1, 918307SHIN4, 918744JC4100, 928779INNOVA1,
936266CL1, 956389INN31, 956632INN4100, 956994INN1, 956994INN2, 972487ANGIO1,
973971LAB3, BPINNOVA2, BPINNOVA3R, BPINNOVA3R, ECXV1406C, FHORLCL1, HC1536XR04,
RU1550VA01, RU2457VA01, SLIN4100, YV0022, and YV0036
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI,
Manufacturer: GE Medical Systems,
SCS, Buc Cedex, France.
REASON Incorrect dose data: After 6 days
and 4 hours without performing a system reset or a system reboot (turning it
off/on), the displayed dose data on these systems (Innova 3100 / Innova 4100
with Bolus option) may be underestimated by up to 50%. In order to avoid this
issue, it is necessary to perform a system reset or reboot every day. GE
Healthcare is working on a correction that will be installed on affected
units.
VOLUME OF PRODUCT IN COMMERCE 146
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) ev3"
55442-2920, sterile EO, single Use, Visi-Pro Balloon-Expandable Peripheral Stent System. Model Numbers: PXB35-05-12-080, PXB35-06-17-135,
PXB35-06-27-080, PXB35-06-57-135, PXB35-07-37-080 ,PXB35-07-57-080,
PXB35-08-17-
080, PXB35-08-17-135, PXB35-08-37-080, PXB35-08-57-080,
PXB35-09-17-135,
PXB35-09-27-080, PXB35-09-27-135, PXB35-09-57-080,
PXB35-10-27-135, and
PXB35-10-37-080,
b) ev3"
sterile EO, single Use, Visi-Pro Balloon-Expandable Biliary Stent System.Model Numbers: PXB35-06-27-135, PXB35-06-37-080, PXB35-07-37-080,
PXB35-
08-17-080, PXB35-08-27-135, PXB35-08-37-135, PXB35-08-57-080, and
PXB35-09-17-135 4800,
CODE
a) Lot Numbers:
3273766, 3273767, 3509137, 4218926, 4361370, 4472112, 4941116, 5012047,
5282885, and 5834997;
b) Lot Numbers: 4089374, 4140341, 4151887, 4194358,
4239470, 4251836, 4484043, 44804047, 4491290, 4933989, 5005731, 5012045,
5045725, 5117532, 5147416, 5149205, 5214432, 5221941, 5239429, and
5577902
RECALLING FIRM/MANUFACTURER Ev3, Inc, Plymouth, MN
REASON
Specific lots
of the Visi-Pro" BE Stent system may not have adequate securement of the stent
to the delivery system and may have a larger diameter/profile than
intended.
VOLUME OF PRODUCT IN COMMERCE 278
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Eclipse
Treatment Planning System, Client 8.1.18 and DCF 8.1.17, model number H48,
CODE
Serial numbers all starting with H48 (model
number): 6509, 6974, 6616, 6688, 6806, 6568, 6530, 6839, 6740, 7178, 6700, 6694,
6505, 6924, 6979, 6715, 6556, 6757, 6820, 6545, 6564, 7027, 6783, 6553, 6760,
6904, 6907, 7037, 6639, 7088, 6702, 6659, 6940, 6802, 6856, 6944, 6841, 6870,
6874, 6928, 6913, 6614, 7009, 6951, 6493, 6758, 7030, 6453, 6704, 6555, 6691,
6914, 6739, 6846, 6685, 6473, 7015, 6875, 6566, 6599, 6818, 7020, 6799, 6804,
6699, 7075, 6901, 6827, 6833, 6681, 6724, 6499, 6698, 6722, 7018, 6782, 6893,
6522, 6937, 6708, 6560, 6977, 6978, 6803, 6961, 6503, 6814, 7029, 6707,
6686
RECALLING FIRM/MANUFACTURER
Recalling Firm: Varian Medical Systems
Oncology Systems, Palo Alto, CA,
Manufacturer: Varian Medical Systems, Finland 04, Helsinki, Finland.
REASON
A software error causes the wedge
accessory calculation to be ignored in the radiotherapy treatment
plan.
VOLUME OF PRODUCT IN COMMERCE 90 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT Puritan-Bennett 800 Series Ventilator Backup Power Source (BPS) Model 802,
CODE
4-070523-SP Battery Assembly 4-840120DIUU-US
4-070520-SP BPS
RECALLING FIRM/MANUFACTURER
Recalling Firm: Covidien
Limited, Boulder, CO,
Manufacturer: Nelicor Puritan Bennett Ireland, Ltd., Galway,
Ireland.
REASON Wiring in battery
back-up power supply may short and cause thermal damage to ventilator.
VOLUME
OF PRODUCT IN COMMERCE 6 Ventilator units and 151 factory replacement
units
DISTRIBUTION Nationwide
PRODUCT
a) Toshiba America Medical Systems (TAMS) Aquilion 32 CT system, computed
tomography x-ray system,
b) Toshiba America Medical
Systems (TAMS) Aquilion 64 CT system, computed tomography x-ray system,
CODE
All codes
RECALLING
FIRM/MANUFACTURER Toshiba American Medical Systems, Inc., Tustin, CA
REASON
Excessive
radiation: Intermittent shifting of CT numbers causes the actual dose to the
patient to be greater than expected, when Sure Exposure option is
used.
VOLUME OF PRODUCT IN COMMERCE 1203
units
DISTRIBUTION Nationwide and
Japan
PRODUCT Siemens Medical
Solutions, syngo Dynamics 6.0 Workplace; Picture archiving and communication
system,
CODE All units with version 6.0
software
RECALLING FIRM/MANUFACTURER Siemens Medical Solutions, USA, Inc.,
Ann Arbor, MI
REASON Incorrect data: A software bug may result in a transfer
of patient demographic data to a different patient’s file.
VOLUME OF PRODUCT
IN COMMERCE 16
units
DISTRIBUTION Nationwide
PRODUCT
a) Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part
number 8515520 equipped with a Digital Electron Variable Applicator (DEVA,
Part Number
8485971) with available energy of 6 MeV. Medical
charged-particle radiation therapy system,
b)
Siemens Medical Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9411588 equipped with a Digital Electron Variable Applicator
(DEVA,
Part
Number 8485971) with available energy of 6 MeV. Medical
charged-particle radiation therapy system,
c)
Siemens Medical Solutions, Mevatron KD-2 Digital Linear Accelerator, part number
9822685 equipped with a Digital Electron Variable Applicator (DEVA, Part
Number
8485971) with available energy of 6 MeV. Medical charged-particle
radiation therapy system,
d) Siemens Medical
Solutions, Mevatron KDS-2 Digital Linear Accelerator, part number 9822693
equipped with a Digital Electron Variable Applicator (DEVA, Part
Number
8485971) with available energy of 6 MeV. Medical charged-particle radiation
therapy system,
e) Siemens Medical Solutions, Mevatron
KD2 Digital Linear Accelerator, part number 1940753 equipped with a Digital
Electron Variable Applicator (DEVA, Part Number
8485971) with available
energy of 6 MeV,
f) Siemens Medical Solutions,
Mevatron M2/ Primus Mid Digital Linear Accelerator, part number 1940035
equipped with a Digital Electron Variable Applicator (DEVA,
Part Number
8485971) with available energy of 6 MeV,
g) Siemens
Medical Solutions, PRIMUS Plus Digital Linear Accelerator, part number 4504200 equipped with a Digital Electron Variable Applicator
(DEVA, Part
Number
8485971) with available energy of 6 MeV,
h)
Siemens Medical Solutions, ONCOR IMPRESSION Plus Digital Linear Accelerator, part number 5857912 equipped with a Digital Electron Variable Applicator
(DEVA, Part Number 8485971) with available energy of 6 MeV,
i) Siemens Medical Solutions, MEVATRON M2-6740 part number
9401407equipped with a Digital Electron Variable Applicator (DEVA, Part
Number 8485971) with
available energy of 6 MeV,
j)
Siemens Medical Solutions, MEVATRON M2-6740 part number 9401506 equipped with a Digital Electron Variable Applicator
(DEVA, Part Number 8485971) with
available energy of 6 MeV,
k) Siemens Medical
Solutions, MEVATRON MD-2 part number 9401654 equipped with a Digital
Electron Variable Applicator (DEVA, Part Number 8485971) with
available
energy of 6 MeV,
CODE
a) Serial numbers: 1938 and
2074;
b) Serial number: 2084;
c) Serial numbers: 2348, 2224, 2431, 2131,
and 2405;
d) Serial numbers: 2348 2224 2431 2131, and 2405;
e) Serial
numbers:3041 2451 2525 2547 2575 2582 2589 2602 2667 2726 2769 2781 2801
2952, and 2571;
f) Serial numbers: 3061 3986 2469 2476 2443 2455 2549 2719
2728 2772 2795 2821 2925 2999 3056 3083 3088 3169 3282 3325 3429 3432 3472
3538 3555 3563 3593
3633 3637 3682 3685 3726 3971 4007 5055 3923 2707 3321,
and 2449;
g) Serial Numbers:3174 3241 3254 2938 3193 3359 3488 3529 3536 3717
3813 3844 3876 3985 3991 4033 4047 2782 2783 2785 2797 2815 2832 2862 2878
2904 2916
2918 2922 2942 2964 2973 2979 2989 2992 2993 2994 3007 3031 3043
3044 3046 3106 3117 3144 3183 3234 3242 3249 3262 3278 3284 3299 3308 3326
3334 3373
3389 3396 3408 3421 3431 3438 3455 3475 3481 3531 3561 3594 3632
3642 3689 3724 3728 3762 3767 3782 3814 3833 3867 3915 4004 4045 4051 4131
4232 5007
3431 3158 3216 3356, and 3619;
h) Serial Number: 3894;
i)
Serial number: 2428;
j) Serial Numbers 2355 and 2417;
k) Serial numbers
2205, 2305, 2362, and 2425
RECALLING FIRM/MANUFACTURER Siemens Medical
Solutions USA, Inc., Concord, CA,
REASON Radiation leak: When used with field
sizes of 5cm x 5cm or smaller, product may leak radiation at a distance of 2 cm
from the side of the applicator body up to 13%, in excess of IEC
standards.
VOLUME OF PRODUCT IN COMMERCE 168
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
X-STOP
Interspinous Process Decompression (lPD) System, (With Physician's Guide, P/N
16000789-01 (Ti device), P/N 16001013-01 (PEEK device); Catalog numbers for
X-STOP Titanium Implant: 1-2206 US 6MM X-STOP, 1-2208 US 8MM X-STOP, 1-2210 US
10MM X-STOP, 1-2212 US 12MM X-STOP, 1-2214 US 14MM X-STOP. Catalog numbers
include for X-STOP PEEK Implant: 1-3206 US 6mm X STOPpk, 1-3208 US 8mm X STOPpk,
1-3210 US 10mm X STOPpk, 1-3212 US 12mm X STOPpk, 1-3214 US 14mm X STOPpk,
1-3216 US 16mm X STOPpk. Spinal implants,
CODE All
units
RECALLING FIRM/MANUFACTURER Kyphon, Inc., Sunnyvale, CA,
REASON
Physician instructions revised due to product breakage:
During the implantation of the X-STOP IPD Device, the product has the potential
to cause damage to and/or breakage of the X-STOP IPD Device's universal wing
assembly. This includes the potential for breakage of the wing screw.
VOLUME
OF PRODUCT IN COMMERCE Approximately 25,000 manuals distributed in the US;
Internationally – undetermined
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
VisuaLine Single Dip Oxycodone; intended for in vitro immunoassay test
completed by visual color comparison used for the detection of drugs of
abuse. Sun Biomedical
Part Number: 15-2016,
b)
VisuaLine Propoxyphene; Propoxyphene test system, intended for in vitro immunoassay test completed by visual color comparison used for the detection
of
drugs of abuse. Sun Biomedical Part Number: 15-2017,
c) VisuaLine Tricyclic Antidepressants: Six Dip
(COC-THC-OPI-MET-BZD-OXD);
Six Dip (COC-THC-OPI-MET-PCP-OXD); Eight DIP (COC-THC-OPI-MET-AMP-BAR-BZD-OXD); Nine Dip(COC-THC-OPI-MET-PCP-AMP-BAR-BZD-TCA);
Ten Dip X(COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-TCA); Ten Dip
(COC-THC-OPI-MET-PCP-AMP-BAR-BZD-MTD-OXD); Ten Dip (COC-THC-
OPI-MET-PCP-AMP-BAR-BZD-TCA-OXD); Five Dip
(COC-THC-OPI-BZD-OXD); and Six Dip (CPC-THC-OPI-MET-AMP-OXD). Product is
intended for in vitro immunoassay test completed by visual color comparison
used for the detection of drugs of abuse. Sun Biomedical 1) Part 15-2043; 2)
Part 15-2046; 3) Part 15-2065; 4) Part 15-2072; 5) Part 15-2080; 6) Part
15-2083; 7) Part 15-2085; 8) Part 15-2095;
and 9) Part 15-2101, Recall #
Z-1875-2008
CODE
a) Lot number Vis-OXD-dip 07-018-1-275 or Vis OXD-Dip
07-081-257;
b) Lot number: Vis-PPX Dip 07-094-1-85;
c) 1) Lot: Vis-6SP-Dip
08-021-1; 2) Lot: Vis-6SP-Dip 07-270-1; 3) Lot: Vis-8SP-Dip-
07-207-2; 4)
Lot: Vis-9SP-Dip-07-106-1; 5) Lot: Vis-10 Dip 06-204-2, Vis-10 Dip 07-
002-2,
Vis-10-Dip-07-231-1; 6) Lot: Vis-10SP-Dip-07-311-1; Vis-10SP-Dip
07-324-1,
VIS 10SP-Dip-08-045-3; 7) Lot: Vis 10SP Dip-07-201-1, Vis-10SP-Dip
07-263-1; 8)
Lot: Vis 5SP-Dip 07-284-2; Vis 5SP-Dip -8-008-01; 9) Lot:
Vis-6SP Dip-07-326-1
RECALLING FIRM/MANUFACTURER Sun Biomedical
Laboratories, Inc., Blackwood, NJ
REASON Product was sold while the devices were under
FDA 510 (k) review, which was subsequently denied.
VOLUME OF PRODUCT IN
COMMERCE 1,137
units
DISTRIBUTION Nationwide
PRODUCT
GE Centricity AW Suite software version 2.0 and 2.0.1 with Card IQ Xpress
Pro or Plus Module; for diagnostic image analysis,
CODE Software version 2.0 and 2.0.1 with Card IQ
Module
RECALLING FIRM/MANUFACTURER GE Healthcare Integrated IT Solutions,
Barrington, IL,
REASON When using any vessel analysis protocol of the AW Suite
Card IQ application, the software can reload saved tracking objects (Save State)
incorrectly and display an incorrect vessel label over the restored images. This
failure only occurs when users create a custom label in the vessel analysis
protocol and include leading or trailing blank characters (space bar) in the
custom label.
VOLUME OF PRODUCT IN COMMERCE 207
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Surgical
Table Column Casing Revision B, Product #0788-200-001 Revision B; component of
Stryker's VERTIER Surgical Table. The tables are AC-powered or air-powered
devices intended for use during diagnostic examination or surgical procedures to
support the patient,
CODE
Lot/Serial #:070119-24045;
070119-24043; 070202-25062; 070319-27231; 070319-27232; 070202-25058;
071026-39230; 071026-39232; 070216-25279; 071019-38649
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Communications Corp., Flower
Mound, TX,
Manufacturer: Merivaara
Corp., Lahti, Finland.
REASON Potential
exists for energy chain, which is responsible for protecting hydraulic and
electrical cables during up and down motion on VERTIER Surgical Table, to become
lodged between column case sections resulting in possible reduction or lose of
function to hand and/or foot controls or possible involuntary movement of the
table.
VOLUME OF PRODUCT IN COMMERCE 10 units
DISTRIBUTION CA, CO,
TX and UT
PRODUCT
a) Vital Port
Vascular Access System Polysulfone Petite with detached 0.9mm catheter; Catalog number IP-S5118-N,
b) Vital Port Vascular
Access System Polysulfone Petite with detached 1.0mm catheter; Catalog
number IP-S6118, CODE
a) Lot number N73127;
b) Lot
number N73153
RECALLING FIRM/MANUFACTURER
Cook Vascular, Inc.,
Vandergrift, PA,
REASON Mislabeled - wrong size catheter was packaged in the
box.
VOLUME OF PRODUCT IN COMMERCE 41 units
DISTRIBUTION Japan and
Brazil
PRODUCT
VectorVision (VV)
Sky Navigation Platform (19" Computer Rack); the 19" computer rack is a
component of the VVsky Vario, BrainSUITE iMRI, BrainSUITE NET and BrainSUITE iCT
systems; Intended to be an intraoperative image guided localization system to
enable minimally invasive surgery. Indicated for any medical condition in which
the use of stereotactic surgery may be appropriate and where a reference to a
rigid anatomical structure can be identified to relative to a CT, CTA, X-ray, MR, MRA and ultrasound based model of the anatomy,
CODE VVsky Art. No. 50945; all VVsky products with Data
Billboards and/or microscope integrations and/or Device Connections Panels (Wall
Panels)
RECALLING FIRM/MANUFACTURER Bainlab AG, Kirchheim B. Muenchen,
Germany,
REASON Diameter of cables used for installation are to small for
the applied current. If an internal short circuit is produced the medical power
supply will not shut down automatically and will continue to deliver current,
which could result in overheating cables.
VOLUME OF PRODUCT IN COMMERCE 23
units
DISTRIBUTION Nationwide
PRODUCT
a) OSS (Orthopedic Salvage System) RS Non-Modular Long Tibial Base, Porous
Coated, 71mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy, sterile; Part 161043.
Implant is part of a system used to replace the tibial portion of the knee
joint,
b) Biomet OSS (Orthopedic Salvage System) RS
Non-Modular Long Tibial Base, 75mm x 10 x 160mm, Co-CR-MO/Ti-6AL-4V alloy,
sterile; Part 161044. Implant is part of a system used to replace the tibial
portion of the knee joint,
CODE
a) Lots 053850,
Exp 08/2016; 070890, Exp 08/2016; 201930, Exp 09/2016; 364790, Exp 10/2016;
507290, Exp 11/2016 and 534910, Exp 04/2017;
b) Lots 173950, Exp 09/2016;
188380, Exp 09/2016; 459420, Exp 11/2016; 534920, Exp 04/2017 and 802650,
Exp 12/2016
RECALLING FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN,
REASON Mislabeled as to size: Product is labeled as reduced size, but is
actually standard size.
VOLUME OF PRODUCT IN COMMERCE 44
units
DISTRIBUTION Nationwide
PRODUCT
a) Dynasty Trial Shell 62mm Group G, REF 3300-GG62, Rx only, Non-Sterile, 1
each, Orthopaedic instrument used for the preparation of the implant site
prior to device
implantation,
b) Dynasty Trial
Shell 64mm OD, Group H, REF 3300-GH64, Rx only, Non-Sterile, 1 each,
Orthopaedic instrument used for the preparation of the implant site prior to device implantation,
c) Dynasty Trial Shell 66mm
OD, Group H, REF 3300-GH66, Rx only, Non-Sterile, 1 each. Orthopaedic
instrument used for the preparation of the implant Recall # Z-2217-2008;
d) Dynasty Trial Shell 68mm OD, Group H,
REF 3300-GH68, Rx only, Non-Sterile, 1 each, Orthopaedic instrument used for
the preparation of the implant site prior to device implantation,
CODE
a) and b) Lot Nos.: 037386983 and 117456822;
c) and d)
Lot Nos.: 037386983 and 117459853
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Wright Medical Technology Inc., Arlington, TN,
Manufacturer: Patterson Machine, Union Grove, AL.
REASON
Trials are 2.5 mm larger than marked.
VOLUME
OF PRODUCT IN COMMERCE 509 units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a) Silhouette
Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3856, Size 6F x
24cm Urological stents are disposable single-use temporary indwelling catheters that allow urine to drain through obstructed or strictured
ureters,
b) Silhouette Xtraflo Device with SL-6
Hydrophilic Coating, Model Number: B3857, Size 6F x 26cm Urological stents
are disposable single-use temporary indwelling catheters that allow urine to
drain through obstructed or strictured ureters, c)
Silhouette Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3855, Size 6F x 22cm Urological stents are disposable single-use temporary
indwelling catheters that allow urine to drain through obstructed or
strictured ureters, d) Silhouette Xtraflo Device
with SL-6 Hydrophilic Coating, Model Number: B3827, Size 6F multilength
Urological stents are disposable single-use temporary indwelling
catheters
that allow urine to drain through obstructed or strictured ureters,
e) Silhouette Xtraflo Device with SL-6 Hydrophilic Coating,
Model Number: BS123, Size 6F multilength Urological stents are disposable
sing-use temporary indwelling
catheters that allow urine to drain through
obstructed or strictured ureters,
f) Silhouette
Xtraflo Device with SL-6 Hydrophilic Coating, Model Number: B3957, Size 6F x
26cm Urological stents are disposable single-use temporary indwelling
catheters that allow urine to drain through obstructed or strictured ureters,
CODE
a) Lot Numbers: 1058016, 1059244
and 1060923;
b) Lot Number: 1059245;
c) Lot Number: 1060602;
d) Lot
Number: 1060921;
e) Lot Number: 1060921 and 1062602;
f) Lot Numbers:
1060924 and 1062803
RECALLING FIRM/MANUFACTURER Applied Medical Resources,
Corp., Rancho Santa Margarita, CA,
REASON Possible movement or dislodgement of the
positioner marker band during use.
VOLUME OF PRODUCT IN COMMERCE 236
units
DISTRIBUTION Nationwide, Australia and South
Africa
PRODUCT
a) Hamilton Soft
Grip Pipettes, 1 ml fixed volume, model number 55019-19 Product is indicated
for manual pipetting, b) Hamilton Soft Grip Pipettes, 1
ml adjustable volume, model number 55019-40 Product is indicated for manual
pipetting,
CODE
a) Serial numbers 64133, 64137,
64139, 64145, 64148, 64156, 64163, 64171, 64175, 4180, 64189, 64192, 64193,
64193, 64198, 64199, 64200, 64202, 64203, 64205, 64211, 64212, 64216, 64224,
64225, 64921, 65072, 65081, 65099, 65105, 65107, 65110, 65140, 65141, 65151,
65159, 65160, 65163, 65164, 65172, 65486, 65501, 65517, 65540, 65585, 65599,
65619, 65629, 65658, 65699, 65934, 65951, 65969, 65972, 65992, 66764, 66783,
66788, 66793, 66892, 66897, 66902, 66972, 66982, 66991, 66999, 67001, 67031,
67035, 67044, 67054, 67055, 67059, 67082, 67084, 67091, 67094, 67098, 67120,
67130, 67145, 67162, 67167, 67170, 67175, 67176, 67190, 67191, 67198, 67224,
67237, 67247, 67258, 67260, 67269, 67278, 67280, 67282, 67283, and 67285;
b) Serial numbers 63045, 63098, 63135, 63157, 63208, 63248, 63278, 63378,
63401, 63418, 63421, 63442, 63461, 63485, 63524, 63527, 63590, 63679, 63753,
63788, 63804, 63820, 63825, 63834, 63836, 63848, 63857, 63885, 63892, 63904,
63951, 63989, 63993, 64047, 64057, 64074, 64076, 64093, 64140, 64160, 64242,
64246, 64261, 64279, 64288, 64289, 64314, 64342, 64352, 64362, 64399, 64407,
64427, 64478, 64479, 64480, 64492, 64498, 64504, 64507, 64518, 64520, 64525,
64527, 64528, 64537, 64538, 64543, 64544, 64563, 64577, 64582, 64585, 64587,
64590, 64592, 64599, 64612, 64628, 64631, 64635, 64636, 64644, 64667, 64678,
64694, 64695, 64703, 64706, 64718, 64720, 64722, 64723, 64729, 64740, 64753, ,
64757, 64759, 64760, 64763, 64767, 64772, 64778, 64785, 64787, 64789, 64792,
64797, 64801, 64810, 65015, 65016, 65018, 65067, 65068, 65071, 65076, 65078,
65079, 65080, 65083, 65090, 65091, 65109, 65119, 65186, 65204, 65224, 65262,
65269, 65290, 65514, 65536, 65541, 65564, 65566, 65567, 65568, 65575, 65576,
65578, 65583, 65590, 65591, 65597, 65600, 65603, 65608, 65609, 65610, 65612,
65614, 65617, 65622, 65623, 65626, 65628, 65631, 65632, 65635, 65644, 65650,
65655, 65657, 65662, 65678, 65692, 65701, 65705, 65707, 65726, 65747, 65771,
65772, 65773, 65777, 65836, 65858, 65906, 65910, 65916, 65917, 65918, 65921,
65925, 65926, 65927, 65929, 65930, 65933, 65935, 65936, 65938, 65946, 65947,
65952, 65953, 65959, 65961, 65964, 65966, 65973, 65979, 65981, 65982, 65983,
65987, 65993, 65995, 65996, 65997, 65998, 65999, 66000, 66002, 66007, 66008,
66013, 66014, 66015, 66016, 66017, 66019, 66062, 66079, 66088, 66104, 66107,
66115, 66124, 66138, 66145, 66174, 66182, 66196, 66197, 66198, 66201, 66205,
66210, 66222, 66226, 66233, 66252, 66253, 66270, 66286, 66289, 66296, 66305,
66309, 66341, 66342, 66345, 66351, 66353, 66361, 66366, 66372, 66373, 66380,
66397, 66398, 66400, 66402, 66403, 66404, 66417, 66418, 66422, 66423, 66425,
66426, 66431, 66434, 66436, 66438, 66443, 66444, 66448, 66450, 66452, 66453,
66456, 66463, 66465, 66474, 66475, 66480, 66483, 66484, 66488, 66490, 66496,
66497, 66503, 66504, 66505, 66512, 66517, 66519, 66520, 66522, 66523, 66534,
66535, 66538, 66540, 66548, 66549, 66550, 66552, 66555, 66556, 66557, 66558,
66560, 66562, 66565, 66567, 66568, 66569, 66573, 66574, 66576, 66577, 66578,
66582, 66584, 66591, 66601, 66603, 66605, 66607, and 66612
RECALLING
FIRM/MANUFACTURER Hamilton Co., Reno, NV,
REASON Manufacturing issue with spring may
restrict product to drawing less than ½ of its stated measured
capacity.
VOLUME OF PRODUCT IN COMMERCE 353
units
DISTRIBUTION Nationwide, PR, New Zealand, Australia, Japan and
Canada
PRODUCT NeuViz Dual series
computed Tomography Scanner System, X-Ray System The CT scanner is a whole body
x-ray computed tomography scanner which features a continuously rotating
tube-detector system and functions according to the fan beam principle,
CODE
Serial numbers 400562, 400563, NDH009EI, NDH011EI,
NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI,
NDH030EI, NDH031EI, and NDH034EI
RECALLING FIRM/MANUFACTURER Philips and
Neusoft Medical Systems, Co., Ltd., Liaoning, China
REASON Labeling of patient
position on scanned image does not match actual patient orientation.
VOLUME
OF PRODUCT IN COMMERCE 15 units
DISTRIBUTION CO, FL, KY, NC, SC, TN and
TX
PRODUCT
1) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242, Intended for
single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
2) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282, Intended for
single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
3) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322, Intended for
single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
4) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362, Intended for
single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
5) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552, Intended for
single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
6) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CSD-15242, Intended
for single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
7) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282, Intended
for single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
8) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CSD-15322, Intended
for single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
9) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362, Intended
for single use only, Sterile, Rx only, The product is used for long
term
hemodialysis vascular access,
10) Cannon Catheter" II,
Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CSD-15552, Intended
for single use only, Sterile, Rx only. The product is used for long
term
hemodialysis vascular access,
11) Cannon" II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-SP, Intended
for single use only, Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
12) Cannon" II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-SP, Intended
for single use only, Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
13) Cannon" II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-SP, Intended
for single use only, Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
14) Cannon" II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-SP, Intended
for single use only, Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
15) Cannon" II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-SP, Intended
for single use only, Sterile, Rx only. Road, The product is used for long
term hemodialysis vascular access,
16) Cannon® II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 19cm, CS-15242-VSP,
Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access,
17) Cannon® II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CS-15282-VSP, Intended
for single use only, Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
18) Cannon® II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 27cm, CS-15322-VSP, Intended
for single use only, Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
19) Cannon® II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CS-15362-VSP,
Intended for single use only, Sterile, Rx only. The product is used for long
term hemodialysis vascular access,
20) Cannon® II Plus,
Long-Term Access. Catheter Length, Cuff to Tip: 50cm, CS-15552-VSP, Intended
for single use only, Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
21) Cannon® II Plus,
Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to
Tip: 19cm, CSD-15242-SP, Intended for single use only, Sterile,
Rx only. The
product is used for long term hemodialysis vascular access,
22) Cannon® II Plus, Hemodialysis Catherization Set,
Long-Term Access. Catheter Length, Cuff to Tip: 23cm, CSD-15282-SP, Intended
for single use only, Sterile,
Rx only. The product is used for long term
hemodialysis vascular access,
23) Cannon® II Plus,
Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to
Tip: 27cm, CSD-15322-SP, Intended for single use only, Sterile,
24) Cannon® II Plus, Hemodialysis Catherization Set,
Long-Term Access. Catheter Length, Cuff to Tip: 31cm, CSD-15362-SP, Intended
for single use only, Sterile,
Rx only. The product is used for long term
hemodialysis vascular access,
25) Cannon® II Plus,
Hemodialysis Catherization Set, Long-Term Access. Catheter Length, Cuff to
Tip: 50cm, CSD-15552-SP, Intended for single use only, Sterile,
Rx only. The
product is used for long term hemodialysis vascular access,
26) Cannon® II Plus, Hemodialysis Catherization Set with
Arrow Simplicity", Long-Term Access, Cuff to Tip: 19cm, CS-15242-SPM,
Intended for single use only,
Sterile, Rx only. The product is used for long
term hemodialysis vascular access,
27) Cannon® II
Plus, Hemodialysis Catherization Set with Arrow Simplicity", Long-Term
Access, Cuff to Tip: 23cm, CS-15282-SPM, Intended for single use only,
Sterile, Rx only. The product is used for long term hemodialysis vascular
access,
28) Cannon® II Plus, Hemodialysis
Catherization Set with Arrow Simplicity", Long-Term Access, Cuff to Tip:
27cm, CS-15322-SPM, Intended for single use only,
Sterile, Rx only. The
product is used for long term hemodialysis vascular access,
29) Cannon® II Plus, Hemodialysis Catherization Set with Arrow
Simplicity", Long-Term Access, Cuff to Tip: 31cm, CS-15362-SPM, Intended for
single use only,
Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
30) ARROW Edge®
Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access,
Cuff to Tip: 19cm, CS-15242-IM, Intended for single use only,
Sterile, Rx
only. The product is used for long term hemodialysis vascular access,
31) ARROW Edge® Hemodialysis Catherization Set with Arrow
Simplicity", Long-Term Access, Cuff to Tip: 23cm, CS-15282-IM, Intended for
single use only,
Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
32) ARROW Edge®
Hemodialysis Catherization Set with Arrow Simplicity", Long-Term Access,
Cuff to Tip: 27cm, CS-15322-IM, Intended for single use only,
Sterile, Rx
only. The product is used for long term hemodialysis vascular access,
33) ARROW Edge® Hemodialysis Catherization Set with Arrow
Simplicity", Long-Term Access, Cuff to Tip: 31cm, CS-15362-IM, Intended for
single use only,
Sterile, Rx only. The product is used for long term
hemodialysis vascular access,
34) ARROW Edge®
Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:31cm,
ASK-15362-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access,
35) ARROW Edge® Hemodialysis Catherization Set, Long-Term
Access, Cuff to Tip:19cm, CS-15242-I, Intended for single use only,
Sterile, Rx only. The product is
used for long term hemodialysis vascular
access,
36) ARROW Edge® Hemodialysis Catherization Set,
Long-Term Access, Cuff to Tip:23cm, CS-15282-I, Intended for single use
only, Sterile, Rx only. The product is
used for long term hemodialysis
vascular access,
37) ARROW Edge® Hemodialysis
Catherization Set, Long-Term Access, Cuff to Tip:27cm, CS-15322-I, Intended
for single use only, Sterile, Rx only. The product is
used for long term
hemodialysis vascular access,
38) ARROW Edge®
Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to
Tip: 31cm, CS-15362-I, Intended for single use only, Sterile, Rx
only. The
product is used for long term hemodialysis vascular access,
39) ARROW Edge® Hemodialysis Catherization Set, Long-Term
Access, Catheter Length, Cuff to Tip: 50cm, CS-15552-I, Intended for single
use only, Sterile, Rx
only. The product is used for long term hemodialysis
vascular access,
40) ARROW Edge® Hemodialysis
Catherization Set, Long-Term Access, Cuff to Tip:19cm, CSD-15242-I,
Intended for single use only, Sterile, Rx only. The product is
used for long
term hemodialysis vascular access,
41) ARROW Edge®
Hemodialysis Catherization Set, Long-Term Access, Cuff to Tip:23cm,
CSD-15282-I, Intended for single use only, Sterile, Rx only. The product is
used for long term hemodialysis vascular access,
42) ARROW Edge® Hemodialysis Catherization Set, Long-Term
Access, Cuff to Tip:27cm, CSD-15322-I, Intended for single use only,
Sterile, Rx only. The product is
used for long term hemodialysis vascular
access,
43) ARROW Edge® Hemodialysis Catherization Set,
Long-Term Access, Catheter Length, Cuff to Tip: 31cm, CSD-15362-I, Intended
for single use only, Sterile, Rx
only. The product is used for long term
hemodialysis vascular access,
44) ARROW Edge®
Hemodialysis Catherization Set, Long-Term Access, Catheter Length, Cuff to
Tip: 50cm, CSD-15552-I, Intended for single use only, Sterile, Rx
only. The
product is used for long term hemodialysis vascular access,
CODE
1) Lot #RL7065076, RL7054704, RL7034338, RL6123772,
RL6113608, RL6103456,
and RL6062695;
2) Lot#RL7054799, RL7044546,
RL044529, RL7034289, RL7024171, RL7013848,
RL6123738, RL6113609, RL6083023,
RL6072946, and RL6062692;
3) Lot#RL7075217, RL7034341, RL7013847, RL6113498,
and RL6093309;
4) Lot# RL8016430, RL7105756, RL7085366, RL7034449, RL7034288,
and RL7013906;
5) Lot# RL6093219;
6) Lot# RL6022012, RL5111395,
RF5061635, and RF5072839;
7) Lot# RL5111237, RL5111325, and RF5061636;
8)
Lot # RL5111238, RL5111377, and RF5072840;
9) Lot # RL5121655;
10) Lot #
RR6032277, RL5111326, and RF5061637;
11) Lot # RL7075215, RL7064985,
RL7064903, RL7054802, RL7054705, RL7044578,
RL7034399, RL7034286, RL7034261,
RL7013996, RL7013949, RL7013902, RL6123700, RL6113625, RL6113607, RL6113514,
RL6103459, RL6103393,
RL6093277, RL6093222, RL6083018, RL6082997, RL6072898,
RL6072876, RL6072850, TL6062700, RL6052656, RL6052609, RL6052575, RL6042517,
RL6032357, RL6032272, RL6022005, RL6011963, RL6011844, RL6011793, RL5121650, RL5121602, RL5090953, RL5080571, RF5072292, RF5061640,
RF5060898, RF65060780, and RF5060301;
12) Lot # RL7075150, RL7064986,
RL7064906, RL7054803, RL7054788, RL7054736,
RL7054683, RL7044663, RL7044624,
RL7044585, RL7044550, RL7044523, RL7034284, RL7034260, RL7024169, RL7024104,
RL7024055, RL7014000,
RL7013948, RL7013904, RL6123775, RL6113626, RL6113515,
RL6103458, RL6103395, RL6103338, RL6093225, RL6083143, RL6083140, RL6083094,
RL6083071, RL6083016, RL6082995, RL6082973, RL6072909, RL6072864, RL6072851, RL6052657, RL6052642, RL6052610, RL6052576, RL6042518,
RL6042442, RL6032353, RL6032273, RL6022085, RL6022007, RL6011823, RL6011738, RL5121604, RL5111324, RL5101066, RL5090954, RL5090813,
RR5080673, RF5072293, RF5061641, RF5060901, RF5060302, RF5054487, RF50546780, and RF5055030;
13) Lot # RL7116004, RL7065080, RL7054804,
RL705735, Lot# RL7054676, Rl7044642, RL7044580, Rl7044502, RL7034343,
RL7034263, RL7024056,
RL7013999, RL7013950, RL6123778, RL6113627, RL6113599,
RL6113492, RL6103457, RL6103394, RL6093276, RL6093220, RL6083122, RL6083020,
RL6072902, RL60172877, RL6062701, RL6052658, RL6052611, RL6052604, RL6052577, RL6042447, RL6042443, RL6032355, RL6021983, RL6011962,
RL6011956, RL6011794, RL6011735, RL5121426, RL5111374, RL5101070,RL5090955, RL5090812, RF5072294, RF5061642, and RF5060483;
14) Lot #
RL7054708, RL7044581, RL7034346, RL7034265, RL7024126, RL7013907, RL6123780,
RL6113628, RL6103472, RL6083021, RL6082998,
RL6072905, RL6072878, RL6062702,
RL6052612, RL6042519, RL6032356, RL6022010, RL6011957, RL6011824, RL5121652,
RL5111412, RL5101060,
RL5090814, RF5084114, and RR5060807;
15) Lot #
RL7075218, RL7064990, RL7064908, RL7054830, RL7044582, RL7034349, RL7034266,
RL7024127, RL6123781, RL6113600, RL6103473,
RL6103401, RL6103364, RL6083123,
RL6083003, RL6072883, RL6062744,RL6052634, RL6052555, RL6042448, RL6032275,
RL6022011, RL6011847,
RL6011825, RL6011739, RL5121605, RL5121428, RL5111376,
RL5090815, RF5072295, and RF5061643;
16) Lot #RL7075165, RL7064971,
RL7044662, RL7034337, RL703420, RL7024049, RL7013953, RL6103343, RL6062812,
and RL6062755;
17) Lot # RL7085440, RL7085404, RL7075211, RL7064954,
RL7044506, RL7024090, RL7013829, RL6103375, RL6062769, and RL6062726;
18)
Lot # RL7095627, RL7095600, RL7085439, RL7075264, RL7075167, RL7065039,
RL7034322, RL7024125, RL7013825, RL6103336, RL6062767, and RL6062747;
19)
Lot # RL7095524, RL7075134, RL7065041, RL7054792, RL7034390, RL7013965,
RL6062819, and RL6062756;
20) Lot # RL7075168, RL7054790, RL7024123,
RL6093201, RL6083117, and RL6062757;
21) Lot # RL7065083, RL7064902,
RL7054801, RL7024113, RL6103474, RL6093296,
RL6083017, RL6082996, RL6062685,
RL5101072, and RL5090957;
22) Lot # RL7085368, RL7075149, RL7044668,
RL7034447, RL7013872, RL6113551,
RL6103403, RL6082978, and RL5090961;
23)
Lot # RL7034372, RL6093298, RL6083063, RL6072900, and RL5090966;
24) Lot #
RL7044504, RL7013995, RL6103475, RL6093299, RL6072906, and RL5111239;
25)
Lot # RL7054829, RL6113552, RL6083022, RL6072884, and RL5101077;
26) Lot #
RL7075164, RL7064972, RL7044661, RL7034319, RL7013952, RL6123683,
RL6113590,
RL6103342, RL6103321, RL6082972, RL6062811, RL6052578, RL6032233, RL6022006,
RL5111401, RL5111314, RL5111273, RL5090749,
RF5071974, and RF5060633;
27)
Lot # RL7095520, RL7085441, RL7085403, RL7075210, RL7065038, RL7054747,
RL7044505, RL7034336, RL7034318, RR7013954, RL7013828, RL6123684, RL6113591, RL6103374, RL6072853, RL6062768, RL6052527, RL6032350,
RL6022008, RL6011846, RL6011741, RL5121549, RL5111399, RL5101067, RL5090754, RF5083471, RF5072252, RF5060634, RF5055030, and RF5054823;
28)
Lot # RL7095626, RL7085438, RL7075166, RL7065040, RL7034321,RL7024124,
RL7013824, RL6123697, RL6103335, RL6083070, RL6082980,
RL6062766, RL6022021,
RL5121547, RL5111400, RL5111259, RF5083830, RF5072253, and RF5060635;
29)
Lot # RL7095523, RL7075133, RL7054791, RL7034389, RL7013964, RL6123685,
RL6083038, RL6082970, RL6062818, RL6032303, RL5121548,
RL5111402, RL5111274,
RL5090726, RF5083831, and RF5060632;
30) Lot # RL7085497, RL7075135,
RL7024105, RL7024062, RL7013817, RL6103430, RL6083098, RL6083036, RL6062788,
RL6052633, RL6022022,
RL6021973, RL5090950, and RR5051996;
31) Lot #
RL7075140, RL7065024, RL7054781, RL7034393, RL7024052, RL7013831,
RL6123782,
RL6103334, RL6083092, RL6072882, RL6062813, RL6062783, RL6052613, RL6042444,
RL6022023, RL6011960, RL5090951, and RF5054861;
32) Lot #RL7075138,
RL7065026, RL7034395, RL7024054, RL7013963, RL6113593, RL6062816, RL6062772,
RR5101171, RL5101008, and RF5054862;
33) Lot# RL7034396, RL6113592,
RL6103341, RL6062790, RL5101009, and R5051995;
34) Lot #8016512;
35)
Lot # RL7075136, RL7034391, RL6083099, RL6083037, RL6062789, RL6011934,
RL5121649, RL5111321, RR5101165, RF5084348, and RF5072121;
36) Lot #
RL7075139, RL7065023, RL7054780, RL7034392, RL7024053, RL7013830,
RL6123783,
RL610333, RL6083093, RL6072881, RL6062814, RL6062784, RR5101166, RL5090831,
and RL5090775;
37) Lot # RL7075137, RL7065025, RL7054779, RL7034394,
RL6113594, RL6083058, RL5121614, RR5101169, RL5090832, RL5090780, and
RF505455;
38) Lot # RL7013940, RL6062791, RR5101168, RL5090833, and
RL5090776;
39) Lot # RL7034397, RL7013939, RL6062815, RL6062792, RL5121654, RL5090834, RL5080628, and RF5060906;
40) Lot# RL7065082, RL6093295, and
RL6082990;
41) Lot # RL7075214, RL6103402, and RL6083025;
42) Lot #
RL6123742, RL6083061, and RL6082992;
43) Lot # RL7064991,and
RL6083027;
44) Lot # RL7065084, and RL6093204
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arrow International Inc., Reading, PA,
Manufacturer: Arrow International Inc.,
Asheboro, NC. REASON The tips may
not have been adequately welded to the catheter body.
VOLUME OF PRODUCT IN
COMMERCE 79,248 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Piccolo
Chemistry Analyzer software version 6.121. Model Number 400-1028 in polyfoil
pouch. Piccolo Comprehensive Metabolic Panel is a single-use self-
contained
reagent disk, intended for use with the Piccolo and PiccoloXpress chemistry
analyzers, for in vitro qualitative determination.,
b)
Piccolo Chemistry Analyzer software version 6.121 with Electrolyte Panel, model number 400-1022 in polyfoil pouch. Piccolo Electrolyte Panel is a
single-use, self-
contained reagent disk intended for use with the Piccolo
and PiccoloXpress chemistry analyzers, for in vitro qualitative
determination,
CODE
a) Lot # 8111AA5, exp. date
2009-03-10;
b) Lot # 8041AC5, exp. date 2009-01-21
RECALLING
FIRM/MANUFACTURER Abaxis, Inc., Union City, CA,
REASON The product will recover tCO2 at
approximately 5-7 units high relative to 03-10.
VOLUME OF PRODUCT IN
COMMERCE 1,130 kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Stryker
Navigation Pin for use with the Stryker Navigation System, 3 mm x 100 mm; Part 6007-003-100. Stryker Navigation Pin for use with the Stryker
navigation
system is used for trauma and orthopedic applications, e.g. hip
and knee modules,
b) Stryker Navigation Pin for use
with the Stryker Navigation System, 3 mm x 150 mm; Part 6007-003-150.
Stryker Navigation Pin for use with the Stryker Navigation
System is used
for trauma and orthopedic applications, e.g. hip and knee modules,
c) Stryker Navigation Pin for use with the Stryker Navigation
System, 4 mm x 100 mm; Part 6007-004-100. Stryker Navigation Pin for use
with the Stryker Navigation
System is used for trauma and orthopedic
applications, e.g. hip and knee modules,
d) Stryker
Navigation Pin for use with the Stryker Navigation System, 4 mm x 150 mm; Part 6007-004-150. Stryker Navigation Pin for use with the Stryker
Navigation
System is used for trauma and orthopedic applications, e.g. hip
and knee modules,
e) Stryker Ortholock EX Pin for
use with the Stryker Navigation System, 3 mm x 110 mm; Part 6007-103-110.
Stryker Navigation Pin for use with the Stryker Navigation
System is used
for trauma and orthopedic applications, e.g. hip and knee modules,
f) Stryker Ortholock EX Pin for use with the Stryker Navigation
System, 4 mm x 150 Mm; Part 6007-104-150. Stryker Navigation Pin for use
with the Stryker Navigation
System is used for trauma and orthopedic
applications, e.g. hip and knee modules,
g) Stryker Ortholock; Part 6007-003-000. Stryker Ortholock is used to firmly anchor a
tracker intended for patient tracking during computer aided orthopaedic and
trauma applications,
CODE All units distributed
prior to 6/5/08.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Stryker
Instruments, Div. of Stryker Corp., Portage, MI,
Manufacturer: Stryker Ireland, Ltd.,
Orthopaedics, Carrigtohill, County
Cork, Ireland.
REASON Instructions have
been updated to include new warnings regarding percutaneous pin placement during
surgery in order to mitigate the risk of femur fractures.
VOLUME OF PRODUCT
IN COMMERCE 28,861 boxes
DISTRIBUTION Nationwide and
Internationally
PRODUCT Miller
bone cement injector front loading cartridge kit, compatible with Zimmer vacuum
mixing system, QTY - 10, sterile; Cat. No. 5069-52. The product is used for the
injection of bone cement,
CODE Lot #
60750536
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc.,
Warsaw, IN,
Manufacturer: Zimmer
Orthopaedic Surgical Products, Dover, OH.
REASON The cartridge is brittle and at increased risk of
breakage.
VOLUME OF PRODUCT IN COMMERCE 257 packages of 10 kits
each
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Zimmer
Patient Helper Reinforced Overhead Bar for Hill-Rom beds with removable headboards; Prod. Nos. 00-0965-000-00 and 00-0965-001-00. The product is an
L shaped bar that is used with hospital beds set up for traction. The bar
allows mounting of a trapeze to help the patient pull themselves up when in
the hospital bed,
b) Zimmer Patient Helper
Reinforce Overhead Bar for Hill-Rom Versa Care beds; The product is a L
shaped bar that is used with hospital beds set up for traction. The bar
allows mounting of a trapeze to help the patient pull themselves up when in
the hospital bed; Prod. Nos. 00-2700-965-02 and 00-0965-001-00,
c) Zimmer Freestanding Patient Helper for Hill-Rom Totalcare
beds; Prod. Nos. 00-2700-965-00 and 00-0965-001-00. The product is a L
shaped bar that is used with hospital beds set up for traction. The bar
allows mounting of a trapeze to help the patient pull themselves up when in
the hospital bed,
CODE All units shipped between
7/11/07 and 5/19/08
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer
Inc., Warsaw, IN,
Manufacturer: Zimmer
Orthopaedic Surgical Products, Dover, OH.
REASON If the bed is in the upright position and the bar is
dropped rapidly or in free-fall, it could strike the patient in the bed, and the
drop could present a laceration hazard by creating a sharp edge on the metal
bar.
VOLUME OF PRODUCT IN COMMERCE 645 units
DISTRIBUTION Nationwide
and Canada
PRODUCT NeuViz Dual
series computed Tomography Scanner System, X-Ray System,
CODE Serial numbers: 400562, 400563, NDH009EI, NDH011EI,
NDH012EI, NDH013EI, NDH016EI, NDH017EI, NDH025EI, NDH026EI, NDH027EI, NDH028EI,
NDH030EI, NDH031EI, and NDH034EI
RECALLING FIRM/MANUFACTURER Philips And
Neusoft Medical Systems Co., Ltd., Shenyang, Liaoning
China,
REASON Potential for R-host box and components inside to be detached of
its mounting during the gantry rotor rotation. There is a potential for
components to be damaged inside the system gantry and for the internal
components to be expelled from the system gantry and injure the patient,
operator, bystander or service people.
VOLUME OF PRODUCT IN COMMERCE 15
units
DISTRIBUTION NC, CO, FL, KY, SC, TN and
TX
PRODUCT Varian Medical Systems
Eclipse device, model H48, Version 6.5 is used to plan photon and electron
radiation therapy treatments,
CODE
H480001 H480341
H480738 H481107 H481548 H482157 H482608 H483158 H483809 H484524 H480003 H480345
H480740 H481108 H481553 H482158 H482609 H483159 H483818 H484535 H480004 H480348
H480749 H481114 H481554 H482159 H482611 H483161 H483820 H484539 H480009 H480351
H480753 H481115 H481556 H482160 H482624 H483164 H483821 H484540 H480012 H480355
H480754 H481116 H481558 H482162 H482625 H483180 H483823 H484544 H480017 H480356
H480756 H481133 H481559 H482163 H482630 H483181 H483830 H484553 H480019 H480357
H480762 H481135 H481567 H482166 H482634 H483191 H483835 H484603 H480022 H480358
H480764 H481141 H481571 H482173 H482638 H483207 H483840 H484610 H480025 H480367
H480766 H481142 H481572 H482178 H482641 H483224 H483843 H484617 H480026 H480371
H480773 H481143 H481573 H482179 H482645 H483244 H483847 H484634 H480030 H480373
H480775 H481163 H481585 H482189 H482648 H483253 H483852 H484639 H480032 H480375
H480776 H481180 H481588 H482198 H482662 H483254 H483858 H484640 H480040 H480382
H480779 H481195 H481597 H482199 H482664 H483255 H483869 H484641 H480042 H480385
H480781 H481196 H481599 H482203 H482671 H483270 H483915 H484643 H480043 H480404
H480794 H481197 H481601 H482204 H482681 H483275 H483916 H484650 H480049 H480411
H480798 H481198 H481602 H482205 H482683 H483277 H483942 H484657 H480050 H480416
H480810 H481205 H481605 H482215 H482691 H483312 H483943 H484658 H480056 H480417
H480814 H481206 H481607 H482225 H482697 H483315 H483970 H484673 H480063 H480418
H480816 H481213 H481609 H482228 H482698 H483317 H483973 H484677 H480067 H480420
H480817 H481226 H481618 H482243 H482704 H483322 H483975 H484680 H480068 H480421
H480820 H481229 H481625 H482244 H482709 H483325 H483984 H484681 H480072 H480432
H480821 H481232 H481627 H482247 H482714 H483328 H483987 H484684 H480073 H480443
H480827 H481239 H481631 H482256 H482715 H483341 H483988 H484695 H480075 H480445
H480830 H481250 H481632 H482264 H482726 H483345 H483991 H484698 H480078 H480455
H480833 H481252 H481641 H482273 H482762 H483355 H483994 H484699 H480095 H480458
H480839 H481257 H481647 H482274 H482763 H483356 H484002 H484706 H480102 H480459
H480852 H481259 H481661 H482283 H482770 H483363 H484003 H484744 H480104 H480461
H480855 H481262 H481678R1 H482284 H482773 H483370 H484010 H484752 H480105
H480462 H480861 H481279 H481681 H482285 H482791 H483371 H484015 H484757 H480108
H480464 H480868 H481285 H481692 H482286 H482796 H483373 H484024 H484770 H480109
H480470 H480873 H481286 H481696 H482288 H482799 H483381 H484031 H484781 H480116
H480478 H480876 H481289 H481698 H482292 H482801 H483384 H484049 H484788 H480117
H480483 H480886 H481294 H481702 H482295 H482803 H483396 H484052 H484839 H480123
H480485 H480891 H481297 H481711 H482327 H482815 H483410 H484053 H484844 H480128
H480486 H480893 H481299 H481715 H482369 H482817 H483424 H484057 H484846 H480129
H480488 H480894 H481312 H481716 H482372 H482818 H483427 H484077 H484856 H480131
H480496 H480896 H481315 H481717 H482374 H482824 H483431 H484083 H484861 H480138
H480500 H480897 H481318 H481718 H482380 H482826 H483434 H484085 H484864 H480140
H480510 H480906 H481319 H481724 H482381 H482832 H483449 H484087 H484873 H480141
H480513 H480907 H481326 H481727 H482389 H482835 H483453 H484099 H484910 H480142
H480530 H480908 H481330 H481748 H482390 H482842 H483459 H484105 H484911 H480151
H480533 H480916 H481334 H481751 H482401 H482844 H483463 H484121 H484912 H480152
H480535 H480923 H481338 H481754 H482403 H482849 H483465 H484124 H484960 H480172
H480536 H480927 H481340 H481758 H482408 H482853 H483466 H484128 H485041 H480174
H480537 H480930 H481341 H481765 H482411 H482856 H483477 H484135 H485053 H480183
H480539 H480933 H481344 H481767 H482418 H482865 H483495 H484144 H485079 H480185
H480542 H480937 H481345 H481768 H482420 H482870 H483496 H484149 H485083 H480186
H480543 H480945 H481352 H481770 H482436 H482871 H483500 H484155 H485113 H480190
H480547 H480946M H481357 H481771 H482438 H482876 H483506 H484160 H485114 H480199
H480549 H480946R1 H481358 H481791 H482439 H482882 H483509 H484161 H485135
H480200 H480554 H480951 H481361 H481797 H482440 H482888 H483525 H484163 H485183
H480201 H480573 H480953 H481364 H481800 H482442 H482890 H483531 H484170 H485188
H480207 H480577 H480958 H481374 H481802 H482448 H482897 H483532 H484174 H485209
H480211 H480587 H480961 H481376 H481803 H482450 H482915 H483535 H484175 H485219
H480212 H480588 H480963 H481377 H481810 H482456 H482921 H483538 H484177 H485268
H480217 H480589 H480964 H481378 H481818 H482460 H482926 H483555 H484180 H485269
H480219 H480596 H480967 H481384 H481824 H482461 H482928 H483557 H484185 H485271
H480220 H480599 H480968 H481389 H481825 H482473 H482941 H483558 H484221 H485276
H480222 H480601 H480970 H481391 H481834 H482484 H482946 H483587 H484228 H485279
H480233 H480606 H480971 H481393 H481837 H482485 H482964 H483591 H484254 H485288
H480238 H480608 H480973 H481401 H481840 H482487 H482982 H483592 H484257 H485311
H480239 H480611 H480974 H481406 H481849 H482489 H482988 H483595 H484258 H485333
H480244 H480615 H480976M H481420 H481857 H482492 H482989 H483602 H484269 H485365
H480245 H480617 H480976R1 H481421 H481859 H482493 H482992 H483606 H484274
H485371 H480247 H480619 H480983 H481423 H481861 H482502 H482993 H483615 H484277
H485389 H480248 H480622 H480985 H481426 H481862 H482506 H483001 H483616 H484280
H485399 H480250 H480626 H480989 H481429 H481880 H482508 H483002 H483619 H484286
H485430 H480265 H480639 H480992 H481431 H481881 H482519 H483010 H483632 H484287
H485453 H480266 H480645 H480993 H481432 H481892 H482520 H483012 H483639 H484321
H485457 H480278 H480651 H480994 H481435 H481893 H482521 H483024 H483646 H484324
H485471 H480281 H480653 H481006 H481436 H481896 H482522 H483028 H483647 H484333
H485520 H480283 H480657 H481011 H481442 H481897 H482531 H483029 H483650 H484337
H485547 H480286 H480658 H481014 H481446 H481900 H482539 H483040 H483654 H484340
H485558 H480289 H480659 H481022 H481448 H481901 H482540 H483042 H483670 H484347
H485569 H480295 H480661 H481041 H481467 H481910 H482544 H483057 H483675 H484348
H485592 H480301 H480662 H481043 H481475 H481911 H482545 H483063 H483679 H484351
H485596 H480305 H480671 H481054 H481486 H481918 H482556 H483088 H483686 H484367
H485628 H480307 H480691 H481058 H481487 H481921 H482561 H483091 H483688 H484371
H485658 H480309 H480692 H481060 H481489 H481927 H482562 H483095 H483690 H484374
H485684 H480311 H480694 H481062 H481493 H481936 H482564 H483103 H483691 H484375
H485692 H480316 H480698 H481063 H481494 H481939 H482566 H483106 H483697 H484383
H485693 H480319 H480702 H481066 H481503 H481940 H482571 H483115 H483706 H484386
H485695 H480321 H480704 H481070 H481504 H481952 H482572 H483117 H483717 H484388
H485696 H480323 H480714 H481071 H481507 H482114 H482578 H483123 H483749 H484421
H485719 H480329 H480717 H481074 H481513 H482120 H482586 H483134 H483750 H484437
H485721 H480333 H480718 H481077 H481515 H482121 H482587 H483138 H483751 H484467
H485846 H480336 H480722 H481079 H481526 H482124 H482590 H483143 H483755 H484476
H485853 H480340M H480726 H481088 H481530 H482125 H482593 H483151 H483757 H484497
H485943 H480340R1 H480727 H481104 H481535 H482129 H482594 H483153 H483767
H484509 H485995 H480732 H481106 H481544 H482151 H482603 H483154 H483803 H484513
H486114 H486135 H486209 H486214 H486250 H486403 H486434 H486657 and
H486313
RECALLING FIRM/MANUFACTURER Varian Medical Systems Oncology
Systems, Palo Alto, CA,
REASON Software anomaly in which swapping IDs of planning fields
can produce inconsistencies between dose matrix and field parameters.
VOLUME
OF PRODUCT IN COMMERCE 907 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT SoftPath
GUI Release Software Versions 3.17 and 4.1. Used in pathology laboratory for
receiving accessing specimen reports, billing and management reports for
surgical, GYN, NON-GYN and Autopsy cases,
CODE Versions 3.17 and 4.1
RECALLING
FIRM/MANUFACTURER SCC Soft Computer, Clearwater, FL,
REASON Loss of text misrepresented individual tissue diagnosis
on the final diagnosis print out from the HIS system software. The specimen
heading "J" was removed and the diagnosis appeared under the specimen heading
"I" as a result the specimen with the heading "I" had two diagnosis.
VOLUME
OF PRODUCT IN COMMERCE 335 units
DISTRIBUTION Nationwide and
Canada
PRODUCT KyphX Osteo
Introducer System with blunt tip introducer stylet (as contained in the KyphoPak
Tray, First Fracture, 15/3 Xpander), catalog number KPT1502, manufactured by
Medtronic Spine LLC. Device is used to access vertebral body during balloon
kyphoplasty, a procedure designed to reduce and stabilize vertebral body
compression fractures (VCFS),
CODE Lot:
J8052810
RECALLING FIRM/MANUFACTURER Kyphon Inc., Sunnyvale, CA,
REASON
Some products
may contain the incorrect introducer stylet. If the treating physician is
unfamiliar with the use and design of the diamond tip stylet, there is a
possibility of serious injuring occurring with the use of the diamond tip stylet
during balloon kyphoplasty procedure. Other risks include delay to surgery and
inconvenience to patient.
VOLUME OF PRODUCT IN COMMERCE 310
units
DISTRIBUTION Nationwide
PRODUCT Isotechnology, Isobalance System; Serial Numbers: 07-030. The product was
being investigated as a device to determine possible inner ear problems,
CODE
Serial numbers: 07-001 through 07-030
RECALLING
FIRM/MANUFACTURER Acacia Engineered Products LLC, Franklin, TN,
REASON
The firm distributed an unapproved medical
device.
VOLUME OF PRODUCT IN COMMERCE 24
units
DISTRIBUTION Nationwide
PRODUCT Steris Small Renaissance Eagle 3000 -- Remanufactured Gravity Models 3011
and 3021 and Prevacuum Models 3013 and 3023. Products are designed for efficient
sterilization of non-porous and porous, heat and moisture-stable materials used
in healthcare facilities,
CODE Model numbers
only
RECALLING FIRM/MANUFACTURER
Recalling Firm: Steris Corp,
Mentor, OH,
Manufacturer:
Steris Mexico, Guadalupe, Mexico.
REASON Some Eagle 3000 units may have a door post pin missing which could
cause incomplete or no engagement of the radial arms into the lock rails of the
door. The sterilizer is designed with switches that prevent cycle initiation if
the door is not locked. However, in the event the door switches are not properly
adjusted they may falsely indicate that the door is locked even though the
radial arms may not be fully engaged correctly. Risks associated with this
problem include burns from escaping steam or injury from the door
failure.
VOLUME OF PRODUCT IN COMMERCE 148
units
DISTRIBUTION Nationwide, Canada and
Mexico
PRODUCT InterGro DBM
Demineralized Bone Matrix in a lipid carrier; REF DBM002. InterGro DBM product
contain human tissue (allograft bpm) and are intended for transplantation.
Products are to be used for filling bony voids or gaps in the extremities, and
pelvis that are not intrinsic to the bony stability of the structure,
CODE
Lots 259990 and 318630 (exp 07/2009).
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Michigan Orthopaedic Products, Inc.,
Grandville, MI,
Manufacturer: EBI, LP,
Parsippany NJ.
REASON Exposure to
temperature extremes -- Product was not stored under controlled conditions and
may have been temperature abused. Exposure to temperature extremes could cause
problems with device safety (e.g. risk of infection) or problems with device
effectiveness (e.g. lower healing rates if the factors or collagen in the device
were affected by the temperature extremes).
VOLUME OF PRODUCT IN
COMMERCE 4
packages
DISTRIBUTION Nationwide
PRODUCT
a) Boston Scientific Platinum Plus Guidewire. Material No. [outer carton
label] H74917511, Catalog # 1751, Material No. [Inner Pouch Label]
H74917510. Sterilized with ethylene oxide gas. The Platinum Plus Guidewire
has been designed to provide torsional control. The guidewire has a
shapeable and highly radiopaque distal platinum tip,
b) Boston Scientific Platinum Plus
Guidewire. Material No.
[outer carton label] H74917521, Catalog # 1752, Material No. [Inner Pouch
Label] H74917520. Sterilized
with ethylene oxide gas. The Platinum Plus
Guidewire has been designed to provide torsional control. The guidewire has
a shapeable and highly radiopaque distal platinum
tip,
c) Boston Scientific Platinum Plus
Guidewire. Material No.
[outer carton label] H74917531, Catalog # 1753, Material No. [Inner Pouch
Label] H74917530. Sterilized
with ethylene oxide gas. The Platinum Plus
Guidewire has been designed to provide torsional control. The guidewire has
a shapeable and highly radiopaque distal platinum
tip,
d) Boston Scientific Platinum Plus
Guidewire. Material No.
[outer carton label] H74917541, Catalog # 1754, Material No. [Inner Pouch
Label] H74917540. Sterilized
with ethylene oxide gas. The Platinum Plus
Guidewire has been designed to provide torsional control. The guidewire has
a shapeable and highly radiopaque distal platinum
tip,
CODE
a) Lot / Batch #: 7908999, 7945613, 7968042, 8002696,
8049604, 8152432, 8181321, 8188798, 8189027, 8260367, 8289723, 8343908, 8350907,
8418323, 8435607, 8506420, 8529856, 8550971, 8584215, 8620500, 8632756, 8632757,
8636509, 8644935, 8656636, 9175918, 9183100, 9200564, 9455621, 9512879, 9521733,
9535932, 9656252, 9747125, 9813152, 11043633, 11122070, 11181968, 11182772,
11194875, 11259816, 11276388, 11328172, 11342423, 11363879, 11518115, 11604154,
and 11665770;
b) Lot / Batch #: 7871050, 7874112, 7901492, 7908998, 7935372,
7942404, 7946750, 7951989, 7979004, 7987978, 8002687, 8002688, 8025772, 8049137,
8056451, 8076852, 8098810, 8100687, 8115174, 8152431, 8181521, 8181914, 8182172,
8188799, 8193187, 8196976, 8199191, 8200479, 8200913, 8250949, 8252697, 8254876,
8260512, 8267344, 8268818, 8276225, 8281144, 8290915, 8334503, 8344727, 8352846,
8355028, 8356527, 8364588, 8410167, 8410168, 8418161, 8436013, 8439527, 8487277,
8494510, 8494814, 8506052, 8517771, 8529765, 8533184, 8547526, 8547528, 8548109,
8563958, 8584214, 8599724, 8620506, 8621310, 8623982, 8624400, 8624593, 8636348,
8636397, 8636409, 8636503, 8641950, 8833124, 8844258, 8856203, 9095461, 9111353,
9115679, 9115681, 9127229, 9157914, 9161086, 9183101, 9183105, 9185694, 9185695,
9188841, 9200553, 9222896, 9255968, 9261438, 9296807, 9297103, 9320040, 9339417,
9339418, 9346642, 9346643, 9368448, 9431674, 9431675, 9431676, 9435282, 9477092,
9478619, 9506755, 9506757, 9506865, 9521490, 9521491, 9521492, 9569394, 9581945,
9581946, 9583721, 9598709, 9603497, 9605899, 9637090, 9640999, 9644150, 9656493,
9656494, 9687546, 9784975, 9804363, 9822697, 11070550, 11099161, 11129198,
11132701, 11181779, 11181961, 11194872, 11204324, 11205127, 11208660, 11210322,
11243379, 11257970, 11258088, 11279186, 11279187, 11304665, 11304666, 11314418,
11314419, 11331413, 11342422, 11364163, 11364164, 11364441, 11364625, 11367614,
11368112, 11381445, 11381446, 11381713, 11400941, 11400942, 11413485, 11416911,
11416912, 11419631, 11421390, 11441801, 11455976, 11466878, 11482433, 11485605,
11491642, 11566831, 11576501, 11576502, 11604153, 11610376, 11610377, 11631997,
and 11632322;
c) Lot / Batch #: 8507682, 8529860, 9012874, 9249774, 9249775,
and 9830636;
d) Lot / Batch #: 7873372, 7909303, 7987688, 8025769, 8049696,
8202657, 8203318, 8260511, 8289582, 8351041, 8372192, 8372883, 8410171, 8418162,
8432959, 8506417, 8533771, and 11643756
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp., Maple Grove, MN,
Manufacturer: Boston Scientific Corp., Miami,
FL
REASON The PTFE (polytetrafluoroethylene) coating on the Platinum Plus Coronary Guidewires could
be damaged in certain locations. This damage of the coating creates the
potential for small particles of the PTFE coating to detach from the wire. If
PTFE particles detach from the guidewire and are released into the coronary
vasculature, the particles may occlude a blood vessel. The most serious adverse
effect that is reasonably expected would be a myocardial infarction. The
particular clinical effect(s) would depend on the site of occlusion. To date,
Boston Scientific has received no complaints in association to this product
issue. Further distribution or use of any remaining product affected by this
recall should cease immediately.
VOLUME OF PRODUCT IN COMMERCE 22,397
single units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Mainline
Confirms Strep A, Group A Streptococcus; A rapid one-step visual test for the
detection of group A streptococcal antigen directly from throat swabs; Catalog
Nos. 3030-20 (20 test) and 3030-40 (40 test), CODE Lot No: 94300
RECALLING FIRM/MANUFACTURER
Mainline
Technology, Inc., Ann Arbor, MI,
REASON Use of an
incorrect dropper tip on the dispenser may result in false positive A
streptococcal results.
VOLUME OF PRODUCT IN COMMERCE 11,520
units
DISTRIBUTION Nationwide
PRODUCT Ace Heat Therapy, A BD Product Up to 10 hours of Soothing Heat; Heat therapy
for muscle and joint pain. Apply Directly to Skin, Instant, Air-Activated Heat
Patches; Catalog Numbers: 207569, 207570, 207535, 207541, 207542, 207543,
207544, 207545, 207549, 207550, 207557, 207565, 207582, 207583, and 207586, CODE
All lots
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Company, Franklin
Lakes, NJ,
Manufacturer: Sanpou Chemical
Co., Tokyo, Japan.
REASON Potential for
skin irritation and burns associated with the use of this product.
VOLUME OF
PRODUCT IN COMMERCE Approximately 703,000
patches
DISTRIBUTION Nationwide
PRODUCT Universal Optical Tracker Fixation, not sterile, REF 111.031. Surgical
instrument,
CODE Lots: 050433, BP050199, BP050258 and
BP050350
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer Inc.,
Warsaw, IN,
Manufacturer: Orthosoft Inc.,
Montreal, Quebec, Canada. REASON Inadequate weld on tracker, knob oversized and poor thread design
on attachment screw results in seizing. The instrument may break during use,
resulting in surgical delay and an increased risk of infection.
VOLUME OF
PRODUCT IN COMMERCE 39
instruments
DISTRIBUTION Nationwide
PRODUCT
a) Caption Disposable Platelet Concentrator Kit, Ref 71178200, 1 each,
Sterile,
b) Caption Disposable Platelet
Concentrator Kit, Ref 71178202, 1 each, Sterile,
CODE
a) Lot Nos.: 07EQT0003, 07EQT0004, 07EQT0005, 07JQT0003,
07KQT0002, 63207107, 07HM12429, and 07JM15582;
b) Lot Nos.: 08EQT0001,
08DQT0001, 08CQT0003, 08BQT0002, and 08AQT0003
RECALLING
FIRM/MANUFACTURER Smith & Nephew, Inc., Memphis, TN,
REASON Product contained a syringe whose package seal integrity
can be adversely affected when the product is exposed to low atmospheric
pressure. This may occur during shipping.
VOLUME OF PRODUCT IN
COMMERCE 9,321
units
DISTRIBUTION Nationwide
PRODUCT
a) DYONICS 25 Fluid Management System bag for enclosure of wireless remote
control
included with Disposable Inflow Tubeset. Catalog # 7211004. Bag is
used for remote Control in a sterile field,
b)
DYONICS 25 Fluid Management System bag for enclosure of wireless remote control included with Disposable Inflow/Outflow Tubeset with Single Suction. Catalog
#7211005. Bag is used for remote in a sterile field, c) DYONICS 25 Fluid Management System Bag for enclosure of wireless remote
control included with Disposable Inflow/Outflow Tubeset with Forked Suction.
Catalog #7211006. Bag is used for remote control in a sterile field,
d) DYONICS 25 Fluid Management System Bag for enclosure of
wireless remote control included with Disposable Patient Tubeset. Catalog #
7211008. Bag is used for remote control in a sterile field,
CODE
a) Lot Numbers: 1548H, 1548J, 1718U, 1758F, 1848U, and
1928F;
b) Lot Numbers: 1688L, 1788H, 1798F, and 1928H;
c) Lot Numbers:
1618F, 1628F, 1758J, 1838K, and 1938F;
d) Lot Numbers:1458F, 1458J, and
1698J
RECALLING FIRM/MANUFACTURER
Recalling Firm: Smith & Nephew, Inc.
Endoscopy Division, Andover, MA,
Manufacturer: Smith & Nephew, Inc Endoscopy Division, Oklahoma City, OK.
REASON
Integrity of the remote control
bag may not be sufficient to prevent tearing or opening of the bag during
use.
VOLUME OF PRODUCT IN COMMERCE 22,239
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) SOMATOM
Emotion 6. Computed tomography X-ray system; Model Numbers: 10165888,
10165977, and 10046789,
b) SOMATOM Emotion 16. Computed
tomography X-ray system; Model Numbers: 10165888, 10165977, and 10046789;
CODE
Model Numbers only
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA,
Manufacturer: Siemens
Shanghai Medical Equipment Ltd., Shanghai, China.
REASON Potential electrical shock hazard. The LCB power Switch
(S1) could break causing the protective plastic cap to come off exposing the
energized electrical contacts within the switch. The LCB S1 does have an inline
fuse which is designed to open in the event of a short circuit condition between
the internal switch contacts.
VOLUME OF PRODUCT IN COMMERCE 53
units
DISTRIBUTION Nationwide
PRODUCT
a) Light Wand Orotracheal Lighted Stylet, Part number: 3910. Sterile,
packaged 20 per case,
b) Vital Signs Intubation
Pack, Part Number: INTPKF, Sterile. Contains one lighted stylet per pack,
c) Light Wand Intro Pack, Part Number: 3960, Sterile.
Contains 5 lighted stylets per pack,
CODE
a) Lot
numbers: 1188D, 1465D, 1683D, 1999D, 2165D, 2461D, 2635D, 2833D, 2856D, 3044E, 3072F, 3129D, 3355H, 3612F, 3673D, 4377F, 5495C, 5496C, 5497C, 5498C,
5668C, 5669C, 6581C, 6582C, 6730C, 7108C, 7256C, 7364C, 7861C, 7970C, 8355C, 8880C, 9233C, 9423C, 9905C, 3854F, 3945G, 3966F, 4013E, 4036N, 4078D, 4103U,
4156M, 4211K, 4222P, 4222R, 4266G, 4281C, 4294J, 4306G, 4318D, 4331A, 4339R,
4358P, 4366X;
b) Lot numbers: X144, X172, X217, X273, X299, X300, X307,
X333, X350, 052A, 081A, 093A, 166A, 271A, 319A, 349A, 033D, 101D, 116D,
164D, 219D, 233D,
291D, 346D, 004F, 058F, 063F, 197F;
c) Lot numbers:
1080D, 1397D, 1623D, 2079D, 2654D, 2949D, 3165D, 3168I, 3207D, 3316H, 3583F,
3693E, 4378W, 4400P, 8045C, 9144C, 9863C, 4022K, 4059F, 4101L, 4198B, 4289Y,
4307A
RECALLING FIRM/MANUFACTURER Vital Signs Colorado, Inc., Englewood,
CO,
REASON Light protector may detach from lighted stylet during
intubation.
VOLUME OF PRODUCT IN COMMERCE 57,792
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
ConMed
Linvatec Surgical Video Cart, Catalogue Number: VP8500,
CODE
Serial #s: 6080185, 6080285, 6080385, 6080485, 6080585,
6080685, 6080785, 6080885, 6080985, 6081085, 6081185, 6081285, 6081385, 6081485,
6081585, 6081685, 6081785, 6081885, 6081985, 6082085, 6082185, 6082285, 6082385,
6082485, 6082585, 6082685, 6082785, 6082885, 6082985, 6083085, 6083185, 6083285,
6083385, 6083485, 6083585, 6083685, 6083785, 6083885, 6083985, 6084085, 6090185,
6090285, 6090385, 6090485, and 6090585
RECALLING FIRM/MANUFACTURER Conmed
Linvatec Endoscopy Division, Goleta, CA,
REASON The recall was initiated
because ConMed Linvatec has determined there is a possibility the wheel caster(s) may become loose which may result in the wheel
caster(s) falling out
of the base of the VP8500 Video Cart. The potential for the wheel caster or
casters to fall out of the base of the cart may result in a potential tip
hazard.
VOLUME OF PRODUCT IN COMMERCE 45
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
AMS 700 CX MS Pump IZ, Preconnect Penoscrotal, 18 cm, Sterile EO, REF 72404232, Manufacture Date
2008 Jun 20,
CODE Lot #: 551668001, Expiration Date
2010-Jun-20
RECALLING FIRM/MANUFACTURER American Medical Systems,
Minnetonka, MN,
REASON The carton labeling does
not match the product packaged inside. The package indicated that the device is
an 18cm Preconnected MS pump while it is actually an 18cm Ultrex Preconnected MS
Pump.
VOLUME OF PRODUCT IN COMMERCE 5
units
DISTRIBUTION LA
PRODUCT
SoftPath ASCII Software Releases 1.2, 2.1, 2.2 and 2.3,
CODE Version 1.2, 2.1, 2.2 and 2.3
RECALLING
FIRM/MANUFACTURER
SCC Soft Computer, Clearwater, FL, by letter beginning
February 23, 2006. Firm initiated recall is complete.
REASON In the
creation of revised report and supplemental reports diagnosis, text was inserted
from another case.
VOLUME OF PRODUCT IN COMMERCE 201
units
DISTRIBUTION Nationwide and Canada
PRODUCT Ev3 The Endovascular
Company, IntraCoil Self-Expanding Peripheral Stent, Sterile EO, Model REF
VT-6-60-135, Use Before 2010-07,
CODE Lot:
4401214
RECALLING FIRM/MANUFACTURER Ev3, Inc., Plymouth, MN,
REASON
An IntraCoil 6 mm
x 40 mm stent was labeled as a 6 mm x 60 mm stent.
VOLUME OF PRODUCT IN
COMMERCE 1 unit
DISTRIBUTION CA
WEEK ENDING OCTOBER 18
PRODUCT Varta
Easypack XL Lithium Polymer Batteries (P/N 41772 and 42215) Used with: Nova
Biomedical StatStrip Glucose Hospital Meter (P/N 42224) and Nova Biomedical
StatSensor Creatinine Hospital Meter and EZ CHEM Creatinine Meter (P/N 9600).
Statstrip Meter an In vitro diagnostic for use by health care professionals in
the quantitative determination of glucose (GLU) in whole blood. EZ Chem In vitro
diagnostic for the quantitative measurement of creatinine in capillary, venous
or arterial blood. The Nova Biomedical products that contain the lithium
batteries include the following part numbers: Part # 41772 - Battery Assy, Part
# 42215 - Battery Replacement pack, Part # 42224 - Kit Meter, Part # 43735 - Kit
Meter EZ CHEM, Part # 43773 - Kit Meter, Part # 43811 - Battery Replacement Pack
EZ CHEM, Part # 44013 - Kit Meter, Part # 44014 - Kit Meter and Part # 44251 -
Kit Meter,
CODE Batteries coded:
XX07 and earlier
RECALLING FIRM/MANUFACTURER Nova
Biomedical Corporation, Waltham, MA,
REASON Lithium batteries may fail if the glucose
or creatinine meters have been dropped.
VOLUME OF PRODUCT IN
COMMERCE 4, 432
batteries
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Product Description : GE Healthcare Innova 3100 Digital
Fluoroscopic Imaging (Cardiovascular Imaging System),
b) GE Healthcare Innova 4100 Digital Fluoroscopic
Imaging,
CODE
a) Systems Id:
8613100, 0910163013, 4103323100, 4103623100, 5034353100,
7083333100, 7278253100, 8019643100, 82416040010, 082416040016, 082416040017, 082416050002, 082416070004, 082416100008,
82416120005, 082416120006, 082416130013, 0002581738X,
06074VAS01, 201541LAB2, 214324INNOVA2, 24516572980IN,
309691P3100, 310423INNOVA1, 313593IC1,
313593IC2,
314525SACL2, 314768SMCL3, 318448INNOVA2, 318449INNOVA2,
409899LAB3, 413447CATH, 413540IN1, 417269SCLD, 502587LAB4, 518525LAB1, 540953INNOVA, 561266IN31, 563421CATHLAB8,
573815BCR1,
600130VA01, 601553CL3, 602239LAB4,
602239LAB6, 602266LAB2, 603778ECL1, 608524NOVA,
615338CV2, 615769SKYCV2, 619340VA8, 619482INNOVA1,
619541INNOVA31, 619552INNOVA1, 702616INNOVA, 7028803100A,
713794LAB7, 713794LAB9, 714966INNOVA, 718283INNOVA3, 724773C1, 731422CV1, 732294INOV, 765453INNOVA1, 770991CL3,
773792CL3100, 773NORWG3100, 803329CL31, 808547QCV2A,
812238LIB1, 812283IN31,
812482INNOVA, 815599FHN3100,
817433HSW3100, 83INNOVA1188379, 850678IN3100,
904202CATH3, 908522LAB1, 928779INNOVA1, 936266CL1,
956389INN31, 956698INN31, 956994INN1, 956994INN2, 973971LAB3, A5108239,
A5203215, BPINNOVA2, BPINNOVA3R, DK1066VA01, FHORLCL1, H1420VAS04, HC1536XR04, IQ1083VA01, IR1747VA01,
LB1160XR07, LV4012VA01, M2848425, M2970614, PL1622VA01,
RU1156VA01, RU1482VA02,
RU1550VA01, RU2457VA01,
TT-2586581-CO, YV0022, YV0026, YV0036;
b) Systems id: 77573841, 80158241,
910063039, 3018774100, 4103374100, 4438494100,
5134754100, 5138534100, 6029234100, 8159374100, 8595724100,
9408984100, 82406010011, 082416130011, 82416130012,
00095VAS07, 205759CL2, 216844INNOVA, 229228INNOV41V,
229434INNOV, 239436CATH1, 251435ICV5, 304255INNOVA,
304347INNOVA, 315448RM4, 315448RM5,
319338VA4100,
325670CATH, 337981INNOVA, 352333VASC, 352376SP,
352401CATH, 352401VASC, 407518SP2, 407518SP3, 407SPECIALS,
414961INN4100, 478633INOV, 508856OR41, 515263IL4100,
516562INNOVA4, 573632CRA, 573761SMA, 574535IN41,
600050VA01, 6012884100SP1, 606833INNOVA, 609652CATH3,
614293LIBERTY1, 614293LIBERTY2,
704487CR41, 706802FINN,
715369INN4100, 717763INNOVA41, 717763OR4100,
718518CVL1,
724656ANG, 727725SPEC1, 727819SPSC, 740592INNOVA,
757398INNOVA, 757736INNOVA, 803329CL41, 804320CATH2B, 804594CATH, 812279INNOVA1, 813972INTV, 816276SP1, 817255NH4100,
828696IN41, 865541CCL5, 865693CCL3, 901726SP2,
903CSM4100, 904276SP, 906485ANGIO,
918307SHIN4,
941483INNOVA41, 956632INN4100, A5630803, B5801711,
BE5005VA01, BY4020VA01, RU1018VA03, SA1188VA03, SLIN4100,
YV0003
RECALLING FIRM/MANUFACTURER
Recalling Firm: Datex
- Ohmeda, Inc., Madison, WI,
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France.
REASON
GE Healthcare has become aware
of a potential condition that may impact operator or patient safety. One
customer has reported that inability to terminate X-ray exposure after releasing
the hand switch control (located in the control room).
VOLUME OF
PRODUCT IN COMMERCE 194
systems
DISTRIBUTION Nationwide and Internationally
PRODUCT
a)
Deltec® 3000 Large Volume Infusion Pump, CE 0473, RX Only. Made in UK. Reorder numbers 21-5301-01 & 21-5306-01. The product
is used for general drug delivery infusion therapies. The
product is only intended to be used by trained
clinicians,
b) Deltec® Micro 3100 Large Volume
Infusion Pump, CE 0473, RX Only. Made in the UK. Reorder
number 21-5311-01. The product is used for general drug delivery
infusion therapies. The product is only intended to be
used by trained clinicians,
CODE All serial numbered
devices
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Smiths Medical MD, Inc., Saint Paul MN, Manufacturer: Smiths Medical International Ltd., Watford, UK.
REASON
The Deltec, Graseby,
and 3M, Large Volume Infusion Pump - Models 3000 and 3100, may deliver an
unintended bolus if the pump door is opened and then immediately closed. This
problem is due to a timing delay when the pumping mechanism resets
itself.
VOLUME OF PRODUCT IN COMMERCE 2,303
units
DISTRIBUTION Nationwide
PRODUCT
a) GE Precision 500D, model 2288798, 2289299, 2290479, 2305472,
2305473, 2305495, 2336900, 2345243, 2401181, 2403790,
2403791, 2404103, 2407276, 2407576, 5179385, 2289299-2,
2290479-2, 2345260-12, 2345260-3, 2403790-3, and
2403791-3, GE Medical Systems - Americas: Milwaukee, USA. The device is used to perform fluoroscopic examination of human anatomy,
b) Advantx Legacy Radiographic and Fluoroscopic
systems, model 2102424, 2118104, 2157009, 2183000,
2206038, 2206048, 2206056, 2224559, 2258627, 2268730, 2330340, 2333974, 2118104-2, 2118104-3, 2118104-4,
2118104-5, 2118104-6, 2118104-7, 2118104-8, 2139574-2,
2147592-13, 2171204-2, 46-262751G6, 46-262751G7,
46-262751G8, 46-275382G58, and 46-302056G1. GE Medical Systems – Americas: Milwaukee, USA. The device is used to perform
fluoroscopic examination of human anatomy,
CODE
a) Serial numbers: 00000004108GQ7,
00000004874GQ4, 00000006742GQ1, 00000007111GQ8, 00000008717GQ1, 00000008892GP2,
00000010136GQ0, 00000012808GP2, 00000013547GP5, 00000013737GP2, 00000013844GP6,
00000985953WK9, 00000987224WK3, 00000987333WK2, 00000989376WK9, 00012966GP8000,
00000000BRBGDM, 00000000BRBGDR, 00000000BRBUF8, 00000000BRD138, 00000000BRF490,
00000000BRF49B, 00000000BRBBXV, 00000000BRBL7V, 00000000BRETRE, 00000986515WK5,
00000097958WK2, 000000980212WK, 00000098186WK0, 00000098235WK4, 00000098734WK5,
00000970756WK3, 00000971704WK2, 00000972504WK5, 00000972505WK2, 00000972772WK8,
00000973070WK6, 00000973500WK2, 00000973502WK8, 00000973616WK6, 00000973617WK4,
00000973618WK2, 00000973624WK0, 00000973883WK2, 00000973884WK0, 00000973885WK7,
00000974085WK3, 00000974087WK9, 00000974410WK3, 00000974411WK1, 00000974412WK9,
00000974445WK9, 00000974446WK7, 00000974447WK5, 00000974676WK9, 00000974677WK7,
00000974678WK5, 00000975166WK0, 00000975167WK8, 00000975169WK4, 00000975171WK0,
00000975172WK8, 00000975626WK3, 00000975627WK1, 00000975628WK9, 00000975629WK7,
00000975630WK5, 00000975631WK3, 00000975632WK1, 00000975946WK5, 00000975947WK3,
00000975948WK1, 00000975949WK9, 00000975958WK0, 00000975959WK8, 00000975960WK6,
00000975961WK4, 00000975962WK2, 00000975964WK8, 00000977046WK2, 00000977047WK0,
00000977048WK8, 00000977049WK6, 00000977050WK4, 00000977051WK2, 00000977052WK0,
00000977053WK8, 00000977054WK6, 00000977055WK3, 00000977233WK6, 00000977234WK4,
00000977236WK9, 00000977238WK5, 00000977239WK3, 00000977853WK1, 00000977854WK9,
00000977855WK6, 00000977857WK2, 00000977858WK0, 00000977859WK8, 00000977860WK6,
00000977861WK4, 00000978079WK2, 00000978080WK0, 00000978082WK6, 00000978083WK4,
00000978084WK2, 00000978085WK9, 00000978086WK7, 00000978485WK1, 00000978486WK9,
00000978487WK7, 00000978488WK5, 00000978489WK3, 00000978490WK1, 00000978491WK9,
00000978492WK7, 00000978493WK5, 00000978494WK3, 00000978715WK1, 00000978716WK9,
00000978826WK6, 00000978827WK4, 00000979056WK9, 00000979057WK7, 00000979083WK3,
00000979084WK1, 00000979097WK3, 00000979125WK2, 00000979126WK0, 00000979150WK0,
00000979151WK8, 00000979206WK0, 00000979207WK8, 00000979227WK6, 00000979228WK4,
00000979256WK5, 00000979257WK3, 00000979380WK3, 00000979381WK1, 00000979388WK6,
00000979389WK4, 00000979390WK2, 00000979391WK0, 00000979448WK8, 00000979449WK6,
00000979450WK4, 00000979466WK0, 00000979467WK8, 00000979468WK6, 00000979469WK4,
00000979516WK2, 00000979517WK0, 00000979518WK8, 00000979584WK0, 00000979638WK4,
00000979639WK2, 00000979640WK0, 00000979641WK8, 00000979691WK3, 00000979692WK1,
00000979693WK9, 00000979827WK3, 00000979828WK1, 00000979894WK3, 00000979895WK0,
00000979896WK8, 00000979897WK6, 00000979898WK4, 00000979941WK2, 00000979942WK0,
00000979944WK6, 00000979945WK3, 00000980041WK8, 00000980042WK6, 00000980043WK4,
00000980044WK2, 00000980045WK9, 00000980183WK8, 00000980213WK3, 00000980317WK2,
00000980318WK0, 00000980319WK8, 00000980321WK4, 0000098032OWK6, 00000980423WK8,
00000980424WK6, 00000980425WK3, 00000980426WK1, 00000980427WK9, 00000980612WK6,
00000980613WK4, 00000980614WK2, 00000980615WK9, 00000980616WK7, 00000980695WK1,
00000980696WK9, 00000980746WK2, 00000980747WK0, 00000980748WK8, 00000980845WK2,
00000980846WK0, 00000980847WK8, 00000980848WK6, 00000980849WK4, 00000980937WK7,
00000980938WK5, 00000980939WK3, 00000980941WK9, 00000980942WK7, 00000980943WK5,
00000980944WK3, 00000980945WK0, 00000980946WK8, 00000981214WK0, 00000981215WK7,
00000981216WK5, 00000981217WK3, 00000981218WK1, 00000981354WK4, 00000981355WK1,
00000981361WK9, 00000981362WK7, 00000981363WK5, 00000981364WK3, 00000981368WK4,
00000981369WK2, 00000981370WK0, 00000981371WK8, 00000981372WK6, 00000981520WK0,
00000981521WK8, 00000981523WK4, 00000981524WK2, 00000981717WK2, 00000981718WK0,
00000981719WK8, 00000981720WK6, 00000981721WK4, 00000981722WK2, 00000981723WK0,
00000981724WK8, 00000981725WK5, 00000981726WK3, 00000981861WK8, 00000981862WK6,
00000981863WK4, 00000981864WK2, 00000981865WK9, 00000981866WK7, 00000981867WK5,
00000981868WK3, 00000981869WK1, 00000982053WK1, 00000982054WK9, 00000982055WK6,
00000982056WK4, 00000982058WK0, 00000982059WK8, 00000982061WK4, 00000982062WK2,
00000982159WK6, 00000982160WK4, 00000982161WK2, 00000982162WK0, 00000982163WK8,
00000982164WK6, 00000982165WK3, 00000982166WK1, 00000982167WK9, 00000982359WK2,
00000982360WK0, 00000982361WK8, 00000982362WK6, 00000982363WK4, 00000982364WK2,
00000982365WK9, 00000982366WK7, 00000982367WK5, 00000982521WK7, 00000982522WK5,
00000982523WK3, 00000982524WK1, 00000982525WK8, 00000982631WK4, 00000982632WK2,
00000982633WK0, 00000982634WK8, 00000982635WK5, 00000982636WK3, 00000982637WK1,
00000982638WK9, 00000982840WK1, 00000982841WK9, 00000982842WK7, 00000982843WK5,
00000982845WK0, 00000982846WK8, 00000982847WK6, 00000982848WK4, 00000982849WK2,
00000983022WK5, 00000983023WK3, 00000983024WK1, 00000983025WK8, 00000983026WK6,
00000983027WK4, 00000983028WK2, 00000983030WK8, 00000983031WK6, 00000983317WK9,
00000983318WK7, 00000983319WK5, 00000983320WK3, 00000983321WK1, 00000983322WK9,
00000983323WK7, 00000983324WK5, 00000983325WK2, 00000983326WK0, 00000983629WK7,
00000983734WK5, 00000983735WK2, 00000983799WK8, 00000983800WK4, 00000983801WK2,
00000983802WK0, 00000984048WK9, 00000984049WK7, 00000984050WK5, 00000984051WK3,
00000984052WK1, 00000984053WK9, 00000984054WK7, 00000984055WK4, 00000984056WK2,
00000984057WK0, 00000984347WK5, 00000984348WK3, 00000984349WK1, 00000984350WK9,
00000984351WK7, 00000984352WK5, 00000984355WK8, 00000984356WK6, 00000984769WK0,
00000984770WK8, 00000984771WK6, 00000985469WK6, 00000985471WK2, 00000985472WK0,
00000985473WK8, 00000986121WK2, 00000986122WK0, 00000986123WK8, 00000986124WK6,
00000986166WK7, 00000986167WK5, 00000986168WK3, 00000986169WK1, 00000986306WK9,
00000986307WK7, 00000986308WK5, 00000986309WK3, 00000986310WK1, 00000986438WK0,
00000986439WK8, 00000986440WK6, 00000986441WK4, 00000986447WK1, 00000986448WK9,
00000986449WK7, 00000986450WK5, 00000986451WK3, 00000986564WK3, 00000986565WK0,
00000986566WK8, 00000987038WK7, 00000987039WK5, 00000987041WK1, 00000987042WK9,
00000987043WK7, 00000987044WK5, 00000987045WK2, 00000987046WK0, 00000987047WK8,
00000987639WK2, 00000987640WK0, 00000987641WK8, 00000987642WK6, 00000987643WK4,
00000987961WK0, 00000987962WK8, 00000987963WK6, 00000987964WK4, 00000987965WK1,
00000988158WK2, 00000988159WK0, 00000988160WK8, 00000988161WK6, 00000988162WK4,
00000988616WK9, 00000988617WK7, 00000988618WK5, 00000988619WK3, 00000988620WK1,
00000988621WK9, 00000988622WK7, 00000988623WK5, 00000988983WK3, 00000988984WK1,
00000988985WK8, 00000988986WK6, 00000988987WK4, 00000988988WK2, 00000988989WK0,
00000989175WK5, 00000989568WK1, 00000989569WK9, 00000989570WK7, 00000989571WK5,
00000989572WK3, 00000989573WK1, 00000989574WK9, 00000989575WK6, 00000989576WK4,
00000989577WK2, 00000989801WK6, 00000989802WK4, 00000989803WK2, 00000989804WK0,
00000989805WK7, 00000989887WK5, 00000989888WK3, 00000989889WK1, 00000989890WK9,
00000989891WK7, 00000989892WK5, 00000989893WK3, 00000990070WK5, 00000990071WK3,
00000990072WK1, 00000990073WK9, 00000990074WK7, 00000990142WK2, 00000990143WK0,
00000990193WK5, 00000990784WK1, 00000990785WK8, 00000990786WK6, 00000990787WK4,
00000990788WK2, 00000990789WK0, 00000990790WK8, 00000990791WK6, 00000990792WK4,
00000990793WK2, 00000991184WK3, 00000991185WK0, 00000991186WK8, 00000991187WK6,
00000009804GP6, 00000008087GQ9, 00000106606DP7, 00000106899DP8, 00000106901DP2,
00000107312DP1, 00000001267M34, 00000001573M35, 00000002001M36, 00000002007M33,
00000003186M34, 00000003245M38, 0000000B8419JP, 00000990473WK1, 00000990475WK6,
00000991351WK8, 00000991513WK3, 00000991517WK4, 00000991520WK8, 00000991525WK7,
00000991529WK9, 00000991537WK2, 00000991538WK0, 00000992468WK9, 00000992506WK6,
00000992507WK4, 00000993566WK9, 00000995819WK0, 00000997090WK6, 00000997877WK6,
00000998406WK3, 00000998812WK2, 00000998814WK8, 00001000445WK5, 00001000446WK3,
00001000926WK4, 00001002184WK8, 00001002227WK5, 00001003777WK8, 00001005647WK1,
00000099310WK0, 00000100227WK1, 00000100464WK3, 00000108883WK9, 00000979829WK9,
00000991248WK6, 00000991249WK4, 00000991250WK2, 00000991251WK0, 00000991252WK8,
00000991254WK4, 00000991255WK1, 00000991282WK5, 00000991778WK2, 00000991827WK7,
00000991828WK5, 00000991829WK3, 00000991981WK2, 00000992023WK2, 00000992024WK0,
00000992025WK7, 00000992026WK5, 00000992027WK3, 00000992028WK1, 00000992029WK9,
00000992030WK7, 00000992031WK5, 00000992032WK3, 00000992148WK7, 00000992149WK5,
00000992150WK3, 00000992151WK1, 00000992152WK9, 00000992153WK7, 00000992154WK5,
00000992155WK2, 00000992156WK0, 00000992157WK8, 00000992431WK7, 00000992432WK5,
00000992433WK3, 00000992434WK1, 00000992435WK8, 00000992436WK6, 00000992437WK4,
00000992438WK2, 00000992439WK0, 00000992440WK8, 00000992990WK2, 00000992991WK0,
00000992992WK8, 00000992993WK6, 00000992994WK4, 00000992995WK1, 00000992996WK9,
00000992997WK7, 00000992998WK5, 00000992999WK3, 00000993109WK8, 00000993110WK6,
00000993111WK4, 00000993112WK2, 00000993665WK9, 00000993666WK7, 00000993667WK5,
00000993668WK3, 00000993671WK7, 00000993672WK5, 00000993673WK3, 00000993674WK1,
00000993957WK0, 00000993958WK8, 00000993959WK6, 00000993960WK4, 00000993961WK2,
00000993962WK0, 00000993963WK8, 00000993964WK6, 00000993965WK3, 00000993966WK1,
00000994146WK9, 00000994147WK7, 00000994148WK5, 00000994149WK3, 00000994150WK1,
00000994151WK9, 00000994152WK7, 00000994269WK9, 00000994270WK7, 00000994272WK3,
00000994273WK1, 00000994638WK5, 00000994639WK3, 00000994640WK1, 00000994641WK9,
00000994642WK7, 00000994643WK5, 00000994645WK0, 00000994788WK8, 00000994789WK6,
00000994790WK4, 00000994791WK2, 00000994792WK0, 00000994793WK8, 00000994794WK6,
00000994795WK3, 00000994796WK1, 00000994797WK9, 00000994889WK4, 00000994890WK2,
00000994891WK0, 00000994892WK8, 00000994893WK6, 00000994894WK4, 00000994895WK1,
00000994896WK9, 00000994897WK7, 00000994898WK5, 00000995487WK6, 00000995488WK4,
00000995489WK2, 00000995490WK0, 00000995491WK8, 00000995492WK6, 00000995494WK2,
00000995495WK9, 00000995496WK7, 00000995773WK9, 00000995774WK7, 00000995775WK4,
00000995776WK2, 00000995777WK0, 00000995779WK6, 00000995780WK4, 00000996267WK1,
00000996268WK9, 00000996269WK7, 00000996270WK5, 00000996271WK3, 00000996272WK1,
00000996273WK9, 00000996274WK7, 00000996275WK4, 00000996276WK2, 00000996504WK7,
00000996506WK2, 00000996507WK0, 00000996508WK8, 00000996509WK6, 00000996512WK0,
00000996699WK5, 00000996700WK1, 00000996701WK9, 00000996749WK8, 00000996750WK6,
00000996751WK4, 00000996753WK0, 00000996754WK8, 00000996755WK5, 00000996756WK3,
00000996757WK1, 00000996758WK9, 00000997238WK1, 00000997239WK9, 00000997240WK7,
00000997241WK5, 00000997242WK3, 00000997243WK1, 00000997245WK6, 00000997247WK2,
00000997578WK0, 00000997579WK8, 00000997580WK6, 00000997582WK2, 00000997583WK0,
00000997584WK8, 00000997585WK5, 00000997586WK3, 00000997587WK1, 00000997791WK9,
00000997792WK7, 00000997793WK5, 00000997794WK3, 00000997795WK0, 00000997796WK8,
00000997797WK6, 00000997798WK4, 00000997799WK2, 00000997800WK8, 00000998301WK6,
00000998302WK4, 00000998303WK2, 00000998304WK0, 00000998305WK7, 00000998552WK4,
00000998553WK2, 00000998554WK0, 00000998555WK7, 00000998556WK5, 00000998557WK3,
00000998558WK1, 00000998559WK9, 00000998560WK7, 00000998850WK2, 00000998851WK0,
00000998956WK7, 00000998957WK5, 00000998958WK3, 00000998959WK1, 00000998960WK9,
00000998961WK7, 00000998962WK5, 00000998963WK3, 00000998964WK1, 00000998965WK8,
00000999312WK2, 00000999313WK0, 00000999314WK8, 00000999315WK5, 00000999316WK3,
00000999317WK1, 00000999318WK9, 00000999319WK7, 00000999320WK5, 00000999321WK3,
00000999650WK5, 00000999651WK3, 00000999713WK1, 00000999772WK7, 00000999773WK5,
00000999774WK3, 00000999775WK0, 00000999776WK8, 00000999777WK6, 00000999778WK4,
00000999779WK2, 00000999780WK0, 00000999781WK8, 00001000370WK5, 00001000371WK3,
00001000372WK1, 00001000373WK9, 00001000374WK7, 00001000375WK4, 00001000376WK2,
00001000377WK0, 00001000378WK8, 00001000379WK6, 00001000634WK4, 00001000635WK1,
00001000637WK7, 00001000638WK5, 00001000695WK5, 00001000696WK3, 00001000697WK1,
00001001127WK8, 00001001128WK6, 00001001130WK2, 00001001131WK0, 00001001132WK8,
00001001133WK6, 00001001134WK4, 00001001135WK1, 00001001136WK9, 00001001353WK0,
00001001354WK8, 00001001355WK5, 00001001356WK3, 00001001357WK1, 00001001358WK9,
00001001524WK6, 00001001525WK3, 00001001606WK1, 00001001607WK9, 00001001608WK7,
00001001609WK5, 00001001610WK3, 00001001611WK1, 00001001612WK9, 00001001613WK7,
00001001614WK5, 00001001615WK2, 00001002004WK8, 00001002005WK5, 00001002006WK3,
00001002007WK1, 00001002008WK9, 00001002009WK7, 00001002010WK5, 00001002150WK9,
00001002151WK7, 00001002153WK3, 00001002154WK1, 00001002155WK8, 00001002442WK0,
00001002443WK8, 00001002444WK6, 00001002445WK3, 00001002446WK1, 00001002447WK9,
00001002448WK7, 00001002449WK5, 00001002450WK3, 00001002451WK1, 00001002876WK9,
00001002877WK7, 00001002878WK5, 00001003002WK1, 00001003003WK9, 00001003004WK7,
00001003005WK4, 00001003083WK1, 00001003448WK6, 00001003449WK4, 00001003450WK2,
00001003451WK0, 00001003452WK8, 00001003454WK4, 00001003455WK1, 00001003456WK9,
00001003457WK7, 00001003458WK5, 00001003459WK3, 00001003460WK1, 00001003461WK9,
00001003463WK5, 00001003464WK3, 00001003465WK0, 00001003466WK8, 00001003467WK6,
00001003975WK8, 00001003976WK6, 00001003977WK4, 00001003978WK2, 00001003979WK0,
00001004333WK9, 00001004334WK7, 00001004335WK4, 00001004336WK2, 00001004337WK0,
00001004339WK6, 00001004340WK4, 00001004341WK2, 00001004342WK0, 00001004634WK0,
00001004635WK7, 00001004636WK5, 00001004638WK1, 00001004639WK9, 00001004641WK5,
00001004643WK1, 00001005079WK7, 00001005081WK3, 00001005082WK1, 00001005083WK9,
00001005084WK7, 00001005085WK4, 00001005573WK9, 00001005574WK7, 00001005575WK4,
00001005576WK2, 00001005577WK0, 00001005578WK8, 00001005580WK4, 00001005581WK2,
00001005582WK0, 00001005800WK6, 00001005801WK4, 00001005802WK2, 00001005803WK0,
00001005804WK8, 00001005805WK5, 00001005806WK3, 00001005807WK1, 00001005975WK6,
00001005976WK4, 00001005977WK2, 00001005978WK0, 00001005979WK8, 00001006458WK2,
00001006459WK0, 00001006460WK8, 00001006461WK6, 00001006462WK4, 00001006463WK2,
00001006464WK0, 00001006465WK7, 00001006466WK5, 00001006467WK3, 00001006644WK7,
00001006645WK4, 00001006646WK2, 00001006881WK5, 00001006882WK3, 00001006883WK1,
00001006884WK9, 00001006885WK6, 00001006886WK4, 00001006887WK2, 00001006889WK8,
00001007298WK1, 00001007299WK9, 00001007300WK5, 00001007505WK9, 00001007506WK7,
00001007507WK5, 00001007618WK0, 00001007619WK8, 00001007620WK6, 00001007621WK4,
00001007623WK0, 00001007624WK8, 00001007625WK5, 00001007626WK3, 00001007627WK1,
00001007763WK4, 00001007764WK2, 00001007765WK9, 00001007868WK1, 00001007869WK9,
00001007870WK7, 00001007871WK5, 00001007872WK3, 00001008134WK7, 00001008135WK4,
00001008137WK0, 00001008138WK8, 00001008139WK6, 00001008140WK4, 00001008141WK2,
00001008142WK0, 00001008143WK8, 00001008509WK0, 00001008734WK4, 00001008735WK1,
00001008736WK9, 00001008737WK7, 00001008739WK3, 00001008740WK1, 00001008741WK9,
00001008742WK7, 00001008743WK5, 00001008879WK7, 00001008881WK3, 00001008882WK1,
00001008883WK9, 00001008908WK4, 00001008909WK2, 00001008911WK8, 00001008912WK6,
00001008913WK4, 00001008914WK2, 00001008915WK9, 00001008990WK2, 00001008991WK0,
00001008992WK8, 00001008993WK6, 00001008994WK4, 00001009079WK3, 00001009080WK1,
00001009081WK9, 00001009082WK7, 00001009083WK5, 00001009084WK3, 00001009085WK0,
00001009086WK8, 00001009236WK9, 00001009238WK5, 00001009239WK3, 00001009274WK0,
00001009301WK1, 00001009331WK8, 00001009332WK6, 00001009334WK2, 00001009335WK9,
00001009337WK5, 00001009338WK3, 00001009539WK6, 00001009540WK4, 00001009541WK2,
00001009542WK0, 00001009543WK8, 00001009577WK6, 00001009578WK4, 00001009639WK4,
00001009640WK2, 00001009641WK0, 00001009642WK8, 00001009643WK6, 00001009644WK4,
00001009646WK9, 00001009647WK7, 00001009766WK5, 00001009768WK1, 00001009769WK9,
00001009770WK7, 00001009771WK5, 00001009772WK3, 00001009774WK9, 00001009775WK6,
00001009857WK2, 00001009858WK0, 00001009859WK8, 00001009860WK6, 00001009889WK5,
00001009939WK8, 00001009940WK6, 00001009941WK4, 00001009943WK0, 00001001973WK5,
00001002235WK8, 00001005072WK2, 00001008710WK4, 00001008860WK7, 00001008918WK3,
00000007106M38, 00000001537M30, 00001004816WK3, 00000098420DP3, 00000000BRENFR,
00000000BRERRL, 00000000BRF4AZ, 00000000BJ0EF3, 00000000BRDDLG, 00000030784B13,
00000060784HP6, 00000061499HP0, 00000067009DP1, 00001009986WK9, 00001010013WK9,
00001010014WK7, 00001010015WK4, 00001010016WK2, 00001010017WK0, 00001010018WK8,
00001010019WK6, 00001010020WK4, 00001010021WK2, 00001010059WK2, 00001010060WK0,
00001010061WK8, 00001010063WK4, 00001010064WK2, 00001010065WK9, 00001010066WK7,
00001010068WK3, 00001010091WK5, 00001010120WK2, 00001010208WK5, 00001010209WK3,
00001010210WK1, 00001010211WK9, 00001010212WK7, 00001010213WK5, 00001010214WK3,
00001010215WK0, 00001010216WK8, 00001010217WK6, 00001010287WK9, 00001010328WK1,
00001010329WK9, 00001010330WK7, 00001010331WK5, 00001010333WK1, 00001010334WK9,
00001010335WK6, 00001010336WK4, 00001010337WK2, 00001010550WK0, 00001010551WK8,
00001010552WK6, 00001010553WK4, 00001010554WK2, 00001010555WK9, 00001010556WK7,
00001010739WK9, 00001010741WK5, 00001010743WK1, 00001010744WK9, 00001010745WK6,
00001010746WK4, 00001010747WK2, 00001010748WK0, 00001010854WK6, 00001010855WK3,
00001010856WK1, 00001010859WK5, 00001010860WK3, 00001010861WK1, 00001010862WK9,
00001010863WK7, 00001011010WK4, 00001011011WK2, 00001011012WK0, 00001011013WK8,
00001011029WK4, 00001011030WK2, 00001011031WK0, 00001011033WK6, 00001011035WK1,
00001011036WK9, 00001011037WK7, 00001011200WK1, 00001011201WK9, 00001011202WK7,
00001011203WK5, 00001011204WK3, 00001011205WK0, 00001011206WK8, 00001011207WK6,
00001011208WK4, 00001011209WK2, 00001011320WK7, 00001011321WK5, 00001011327WK2,
00001011328WK0, 00001011340WK5, 00001011341WK3, 00001011342WK1, 00001011343WK9,
00001011344WK7, 00001011345WK4, 00001011346WK2, 00001011347WK0, 00001011348WK8,
00001011349WK6, 00001011513WK7, 00001011514WK5, 00001011515WK2, 00001011516WK0,
00001011517WK8, 00001011518WK6, 00001011519WK4, 00001011520WK2, 00001011521WK0,
00001011657WK2, 00001011761WK2, 00001011762WK0, 00001011763WK8, 00001011764WK6,
00001011765WK3, 00001011766WK1, 00001011767WK9, 00001011768WK7, 00001011769WK5,
00001011770WK3, 00001011875WK0, 00001011876WK8, 00001011877WK6, 00001011878WK4,
00001011879WK2, 00001011887WK5, 00001011888WK3, 00001011889WK1, 00001011890WK9,
00001011891WK7, 00001012024WK4, 00001012025WK1, 00001012026WK9, 00001012027WK7,
00001012028WK5, 00001012029WK3, 00001012030WK1, 00001012031WK9, 00001012032WK7,
00001012033WK5, 00001012176WK2, 00001012177WK0, 00001012178WK8, 00001012179WK6,
00001012180WK4, 00001012181WK2, 00001012182WK0, 00001012183WK8, 00001012186WK1,
00001012187WK9, 00001012188WK7, 00001012189WK5, 00001012190WK3, 00001012191WK1,
00001012192WK9, 00001012193WK7, 00001012194WK5, 00001012195WK2, 00001012432WK9,
00001012434WK5, 00001012435WK2, 00001012499WK8, 00001012500WK3, 00001012501WK1,
00001012502WK9, 00001012503WK7, 00001012505WK2, 00001012506WK0, 00001012508WK6,
00001012541WK7, 00001012542WK5, 00001012543WK3, 00001012546WK6, 00001012547WK4,
00001012548WK2, 00001012549WK0, 00001012881WK7, 00001012883WK3, 00001012884WK1,
00001012885WK8, 00001012888WK2, 00001012889WK0, 00001012991WK4, 00001012992WK2,
00001012993WK0, 00001012994WK8, 00001012995WK5, 00001012996WK3, 00001012997WK1,
00001012998WK9, 00001013087WK0, 00001013088WK8, 00001013089WK6, 00001013090WK4,
00001013102WK7, 00001013176WK1, 00001013177WK9, 00001013178WK7, 00001013179WK5,
00001013181WK1, 00001013182WK9, 00001013183WK7, 00001013184WK5, 00001013185WK2,
00001013293WK4, 00001013294WK2, 00001013298WK3, 00001013299WK1, 00001013301WK5,
00001013302WK3, 00001013576WK2, 00001013577WK0, 00001013578WK8, 00001013579WK6,
00001013580WK4, 00001013581WK2, 00001013582WK0, 00001013583WK8, 00001013584WK6,
00001013585WK3, 00001013726WK3, 00001013728WK9, 00001013729WK7, 00001013731WK3,
00001013732WK1, 00001013733WK9, 00001013734WK7, 00001013735WK4, 00001013968WK1,
00001013969WK9, 00001013970WK7, 00001013971WK5, 00001013972WK3, 00001013974WK9,
00001013976WK4, 00001013977WK2, 00001014092WK9, 00001014093WK7, 00001014094WK5,
00001014095WK2, 00001014097WK8, 00001014098WK6, 00001014099WK4, 00001014279WK2,
00001014280WK0, 00001014392WK3, 00001014394WK9, 00001014395WK6, 00001014396WK4,
00001014397WK2, 00001014398WK0, 00001014399WK8, 00001014549WK8, 00001014550WK6,
00001014551WK4, 00001014553WK0, 00001014556WK3, 00001014702WK3, 00001014703WK1,
00001014704WK9, 00001014705WK6, 00001014706WK4, 00001014707WK2, 00001014708WK0,
00001014710WK6, 00001014711WK4, 00001014866WK6, 00001014953WK2, 00001014958WK1,
00001014959WK9, 00001014960WK7, 00001014961WK5, 00001014962WK3, 00001015088WK6,
00001015092WK8, 00001015093WK6, 00001015096WK9, 00001015219WK7, 00001015220WK5,
00001015292WK4, 00001015293WK2, 00001015295WK7, 00001015297WK3, 00001015298WK1,
00001015559WK6, 00001015562WK0, 00001015563WK8, 00010103324WK3, 00001013029WK9,
and 00001013807WK1;
b) Serial numbers: 000000000BH563, 00000004777GP9,
00000005003GP9, 00000014648GP0, 00000046998VP1, 00000048828VP8, 00000054168VP0,
00000054198VP7, 00000062777ES8, 00000062779ES4, 00000062797ES6, 00000062797VP6,
00000062813VP1, 00000062839ES6, 00000065436VP8, 00000066102DP5, 00000066138DP9,
00000076156MA9, 00000077242DP6, 00000077245DP9, 00000077246DP7, 00000077348MA1,
00000080468MA2, 00000084227VP8, 00000095705VP0, 00000097498WK1, 000000T7113MA8,
00000419764BU6, 00000431324BU3, 00000491331WK5, 00000493021WK0, 00000493022WK8,
00000494787WK5, 00000495471WK5, 00000495922WK7, 00000495960WK7, 00000498299WK7,
00000498516WK4, 00000498844WK0, 00000499720WK1, 00000499789WK6, 00000499936WK3,
00000500252WK2, 00000500371WK0, 00000500420WK5, 00000500452WK8, 00000500631WK7,
00000500800WK8, 00000500961WK8, 00000501080WK6, 00000501165WK5, 00000501317WK2,
00000501405WK5, 00000501497WK2, 00000501624WK1, 00000501678WK7, 00000501690WK2,
00000501845WK2, 00000502382WK5, 00000502469WK0, 00000502656WK2, 00000502668WK7,
00000502673WK7, 00000502695WK0, 00000502802WK2, 00000503403WK8, 00000503589WK4,
00000503651WK2, 00000503720WK5, 00000503889WK8, 00000503918WK5, 00000504087WK8,
00000504160WK3, 00000504221WK3, 00000504364WK1, 00000504537WK2, 00000504561WK2,
00000504626WK3, 00000504708WK9, 00000504795WK6, 00000504902WK8, 00000504944WK0,
00000505067WK9, 00000505194WK1, 00000505213WK9, 00000505230WK3, 00000505232WK9,
00000505354WK1, 00000505451WK5, 00000505565WK2, 00000505950WK6, 00000505965WK4,
00000506038WK9, 00000506375WK5, 00000506408WK4, 00000506445WK6, 00000506488WK6,
00000506569WK3, 00000506570WK1, 00000506775WK6, 00000506799WK6, 00000506800WK2,
00000506963WK8, 00000507015WK6, 00000507025WK5, 00000507170WK9, 00000507237WK6,
00000507579WK1, 00000507580WK9, 00000507827WK4, 00000508212WK8, 00000508240WK9,
00000508339WK9, 00000508340WK7, 00000508460WK3, 00000508478WK5, 00000508509WK7,
00000508653WK3, 00000508686WK3, 00000509091WK5, 00000509092WK3, 00000509188WK9,
00000509194WK7, 00000509195WK4, 00000509202WK8, 00000509609WK4, 00000509806WK6,
00000509916WK3, 00000509991WK6, 00000510108WK4, 00000510319WK7, 00000510325WK4,
00000510326WK2, 00000510493WK0, 00000510518WK4, 00000510774WK3, 00000510873WK3,
00000510874WK1, 00000511384WK0, 00000511507WK6, 00000511508WK4, 00000511509WK2,
00000511689WK2, 00000511730WK4, 00000512111WK6, 00000512199WK1, 00000512413WK6,
00000512414WK4, 00000512415WK1, 00000512632WK1, 00000512850WK9, 00000512851WK7,
00000512852WK5, 00000513150WK3, 00000513151WK1, 00000513152WK9, 00000513796WK3,
00000513797WK1, 00000513819WK3, 00000514016WK5, 00000514026WK4, 00000514030WK6,
00000514185WK8, 00000514342WK5, 00000514425WK8, 00000514595WK8, 00000514833WK3,
00000514882WK0, 00000514883WK8, 00000514885WK3, 00000515060WK2, 00000515206WK1,
00000515334WK1, 00000515375WK4, 00000515401WK8, 00000515454WK7, 00000515707WK8,
00000515769WK8, 00000516111WK2, 00000516203WK7, 00000516228WK4, 00000516513WK9,
00000516514WK7, 00000516665WK7, 00000516955WK2, 00000516978WK4, 00000517033WK7,
00000517098WK0, 00000517109WK5, 00000517371WK1, 00000517419WK8, 00000517731WK6,
00000517740WK7, 00000517741WK5, 00000517901WK5, 00000517902WK3, 00000517903WK1,
00000517904WK9, 00000518252WK2, 00000518519WK4, 00000518520WK2, 00000518881WK8,
00000518882WK6, 00000519272WK9, 00000519273WK7, 00000519274WK5, 00000519275WK2,
00000519528WK4, 00000519529WK2, 00000519579WK7, 00000519580WK5, 00000519633WK2,
00000519679WK5, 00000519995WK5, 00000520047WK2, 00000520142WK1, 00000520171WK0,
00000520226WK2, 00000520361WK7, 00000520389WK8, 00000520515WK8, 00000520658WK6,
00000520672WK7, 00000520890WK5, 00000520926WK7, 00000521213WK9, 00000521214WK7,
00000521295WK6, 00000521296WK4, 00000521297WK2, 00000521298WK0, 00000521640WK3,
00000521641WK1, 00000521642WK9, 00000521918WK3, 00000522091WK8, 00000522240WK1,
00000522279WK9, 00000522280WK7, 00000522281WK5, 00000522329WK2, 00000522484WK5,
00000522511WK5, 00000522547WK9, 00000522596WK6, 00000522597WK4, 00000522606WK3,
00000522867WK1, 00000522868WK9, 00000522900WK0, 00000522901WK8, 00000523291WK3,
00000523356WK4, 00000523357WK2, 00000523403WK4, 00000523593WK2, 00000523594WK0,
00000523705WK2, 00000523706WK0, 00000523753WK2, 00000524133WK6, 00000524134WK4,
00000524254WK0, 00000524255WK7, 00000524326WK6, 00000524628WK5, 00000524629WK3,
00000524634WK3, 00000524635WK0, 00000524683WK0, 00000524776WK2, 00000524857WK0,
00000524858WK8, 00000524936WK2, 00000525031WK1, 00000525107WK9, 00000525280WK4,
00000525289WK5, 00000525290WK3, 00000525291WK1, 00000525566WK6, 00000525709WK2,
00000525782WK9, 00000525807WK4, 00000526001WK3, 00000526002WK1, 00000526151WK6,
00000526268WK8, 00000527094WK7, 00000527116WK8, 00000527123WK4, 00000527195WK2,
00000527285WK1, 00000527506WK0, 00000527732WK2, 00000527733WK0, 00000527943WK5,
00000527972WK4, 00000527988WK0, 00000528106WK8, 00000528263WK7, 00000528377WK5,
00000528378WK3, 00000528379WK1, 00000528380WK9, 00000528515WK0, 00000528917WK8,
00000529015WK0, 00000529181WK0, 00000529193WK5, 00000529251WK1, 00000529286WK7,
00000529445WK9, 00000529488WK9, 00000529638WK9, 00000529640WK5, 00000529641WK3,
00000529642WK1, 00000529809WK6, 00000529810WK4, 00000529812WK0, 00000529971WK4,
00000530184WK1, 00000530224WK5, 00000530225WK2, 00000530226WK0, 00000530370WK6,
00000530443WK1, 00000530444WK9, 00000530504WK0, 00000530505WK7, 00000530506WK5,
00000530507WK3, 00000530675WK8, 00000530678WK2, 00000530680WK8, 00000530686WK5,
00000530966WK1, 00000531026WK3, 00000531027WK1, 00000531028WK9, 00000531029WK7,
00000531030WK5, 00000531031WK3, 00000531032WK1, 00000531034WK7, 00000531047WK9,
00000531418WK2, 00000531421WK6, 00000531558WK5, 00000531559WK3, 00000531560WK1,
00000532010WK6, 00000532011WK4, 00000532015WK5, 00000532016WK3, 00000532017WK1,
00000532018WK9, 00000532019WK7, 00000532357WK1, 00000532359WK7, 00000532360WK5,
00000532543WK6, 00000532545WK1, 00000532546WK9, 00000532547WK7, 00000532753WK1,
00000532898WK4, 00000532959WK4, 00000532960WK2, 00000532961WK0, 00000533224WK2,
00000533327WK3, 00000533328WK1, 00000533524WK5, 00000533568WK2, 00000533611WK0,
00000533856WK1, 00000534042WK7, 00000534073WK2, 00000534105WK2, 00000534123WK5,
00000534153WK2, 00000534213WK4, 00000534214WK2, 00000534267WK0, 00000534316WK5,
00000534373WK6, 00000534374WK4, 00000534498WK1, 00000534502WK0, 00000534503WK8,
00000534583WK0, 00000534675WK4, 00000534695WK2, 00000534903WK0, 00000534905WK5,
00000534906WK3, 00000534907WK1, 00000534908WK9, 00000534911WK3, 00000534912WK1,
00000534913WK9, 00000535507WK8, 00000535508WK6, 00000535543WK3, 00000535544WK1,
00000535545WK8, 00000535550WK8, 00000535797WK5, 00000535798WK3, 00000535799WK1,
00000535800WK7, 00000536014WK4, 00000536016WK9, 00000536106WK8, 00000536225WK6,
00000536226WK4, 00000536227WK2, 00000536390WK8, 00000536395WK7, 00000536397WK3,
00000536472WK4, 00000536478WK1, 00000536479WK9, 00000536480WK7, 00000536666WK1,
00000536868WK3, 00000536869WK1, 00000536870WK9, 00000536871WK7, 00000536877WK4,
00000537578WK7, 00000537580WK3, 00000537640WK5, 00000537973WK0, 00000538098WK5,
00000538176WK9, 00000538197WK5, 00000538301WK3, 00000538353WK4, 00000538573WK7,
00000538574WK5, 00000538575WK2, 00000538649WK5, 00000538731WK1, 00000538795WK6,
00000538913WK5, 00000539002WK6, 00000539057WK0, 00000539174WK3, 00000539175WK0,
00000539180WK0, 00000539207WK1, 00000539353WK3, 00000539673WK4, 00000539674WK2,
00000539679WK1, 00000539680WK9, 00000539682WK5, 00000539683WK3, 00000539684WK1,
00000539685WK8, 00000539688WK2, 00000539689WK0, 00000539690WK8, 00000539691WK6,
00000539692WK4, 00000539909WK2, 00000539920WK9, 00000539921WK7, 00000539985WK2,
00000540123WK7, 00000540214WK4, 00000540271WK4, 00000540570WK9, 00000540947WK9,
00000540993WK3, 00000540994WK1, 00000540995WK8, 00000540996WK6, 00000541160WK8,
00000541201WK0, 00000541338WK0, 00000541368WK7, 00000541395WK0, 00000541503WK9,
00000541504WK7, 00000541528WK6, 00000541529WK4, 00000541835WK5, 00000541861WK1,
00000541863WK7, 00000541864WK5, 00000541865WK2, 00000541867WK8, 00000541898WK3,
00000541899WK1, 00000541900WK7, 00000542015WK3, 00000542016WK1, 00000542247WK2,
00000542382WK7, 00000542536WK8, 00000542573WK1, 00000542574WK9, 00000542575WK6,
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00000989800WK8, 00000990810WK4, 00000992097WK6, and
00000992098WK4
RECALLING FIRM/MANUFACTURER GE Healthcare,
Waukesha, WI,
REASON GE Healthcare was notified that 2 recently
installed Precision 500D systems were not in compliance with portions of the
Performance Standard for Diagnostic X-ray Equipment. X-ray production was
possible from the fluoroscopic X-ray tube when the Primary Protective Barrier
was not in position to intercept the X-ray beam. Users are recommended to follow
good clinical standards to ensure the Image Intensifier carriage assembly is in
the forward and locked position over the table top prior to initiating a
fluoroscopic X-ray procedure. A GE Healthcare Field Engineer will schedule a
field visit to inspect and replace the park latch switch, as
needed.
VOLUME OF PRODUCT IN COMMERCE 2,863
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Ultraview
Digital Telemetry Transmitter, Model 90478 The Spacelabs Medical Digital
Telemetry system provides continuous electrocardiographic (ECG) monitoring to
detect ST segment changes, abnormal cardiac rhythms, including asystole,
ventricular fibrillation and ventricular tachycardia,
CODE
Serial Numbers 478-111508, 478-111509,
478-111510, 478-111511, 478-111962, 478-111963, 478-111964, 478-111965, ,
478-114831, 478-117016, 478-117395, 478-117602, 478-122332, 478-122333,
478-122535, 478-124039, 478-124040, 478-124042, 478-124055, 478-108923,
478-108924, 478-108925, 478-108926, 478-108927, 478-108928, 478-108929,
478-108930, 478-112419, 478-112420, 478-112421, 478-112422, 478-114943,
478-114944, 478-114945, 478-114946, 478-114947, 478-114948, 478-114949,
478-114950, 478-114951, 478-114952, 478-122698, 478-122704, 478-122711,
478-137602, 478-137603, 478-144927, , 478-122680, 478-122680, 478-122680,
478-122680, 478-128481, 478-128483, 478-128515, 478-128525, 478-112052,
478-113089, 478-113097, 478-113704, 470-110122, 478-110126, 478-110939,
478-110940, 478-113098, 478-113099, 478-113101, 478-120415, 478-122158,
478-122159, 478-122163, 478-124049, 478-124057, 478-124058, 478-124570,
478-124571, 478-124994, 478-124996, 478-113527, 478-113528, 478-113529,
478-113530, 478-113531, 478-113532, 478-113533, 478-113761, 478-111405,
478-111803, 478-111827, 478-111828, 478-111829, 478-111836, 478-111837,
478-111838, 478-111839, 478-111840, 478-111841, 478-111842, 478-111843,
478-111844, 478-111845, 478-111846, 478-111847, 478-111848, 478-111849,
478-111850, 478-111851, 478-111852, 478-111853, 478-111854, 478-111887,
478-111888, 478-111996, 478-112013, 478-112014, 478-112016, 478-118020,
478-118367, 478-119474, 478-119475, 478-122679, 478-122685, 478-122687,
478-122688, 478-122691, 478-122692, 478-124272, 478-124274, 478-124723,
478-124724, 478-124725, 478-124726, 478-124732, 478-124733, 478-124734,
478-124735, 478-124736, 478-124739, 478-124740, 478-124741, 478-124742,
478-124743, 478-124748, 478-124750, 478-124751, 478-124762, 478-127124,
478-127129, 478-127155, 478-127473, 478-127997, 478-128063, 478-128067,
478-128528, 478-114841, 478-114866, 478-114868, 478-114869, 478-114870,
478-114871, 478-114872, 478-114873, 478-105101, 478-105145, 478-105269,
478-105481, 478-105531, 478-105617, 478-105634, 478-106017, 478-110011,
478-110012, 478-110013, 478-110024, 478-110025, 478-111180, 478-115421,
478-113006, 478-113007, 478-113008, 478-113010, 478-115358, 478-117023,
478-117034, 478-117074, 478-118351, 478-118352, 478-122327, 478-122329,
478-123849, 478-123854, 478-123941, 478-123949, 478-128001, , 478-129153, ,
478-120034, 478-120040, 478-120041, 478-120047, 478-106809, 478-106810,
478-105975, 478-110117, 478-110123, 478-115390, 478-115426, 478-116810,
478-116817, 478-116824, 478-117122, 478-117126, 478-117127, 478-118041,
478-118256, 478-124126, 478-124127, 478-124128, 478-124331, 478-125680,
478-125681, 478-125682, 478-128661, 478-128662, 478-128665, 478-128667,
478-129167, 478-129684, 478-129687, 478-129691, , 478-129949, , 478-132784,
478-132785, 478-127983, 478-127985, 478-127990, 478-127991, 478-127993,
478-127994, 478-127995, 478-128020, 478-107614, 478-107615, 478-107616,
478-107617, 478-107618, 478-107613, 478-100222, 478-100501, 478-105173,
478-105174, 478-108214, 478-108353, 478-108527, 478-108648, 478-128336,
478-128337, 478-128548, 478-128551, 478-128552, 478-128555, 478-128556,
478-128557, 478-127070, 478-127083, 478-128450, 478-128487, 478-110116,
478-110192, 478-110193, 478-110194, 478-110238, 478-130761, 478-131067,
478-131068, 478-131070, 478-131071, 478-131072, 478-130563, 478-130773,
478-130774, 478-130775, 478-130776, 478-130777, 478-130778, 478-130779,
478-130780, 478-130781, 478-130782, 478-131692, 478-131693, 478-132052,
478-132236, 478-132779, 478-132795, 478-132796, 478-132797, 478-132798,
478-132799, 478-132800, 478-132801, 478-132802, 478-134083, 478-134084,
478-134085, 478-134086, 478-134087, 478-134088, 478-134089, 478-134090,
478-134091, 478-131671, 478-132283, 478-132287, 478-132320, 478-132321,
478-132695, 478-132696, 478-132697, 478-132698, 478-132699, 478-132700,
478-132701, 478-132702, 478-132703, 478-132704, 478-132705, 478-132706,
478-132707, 478-132708, 478-132709, 478-132710, 478-132711, 478-132712,
478-132713, 478-132715, 478-132716, 478-132717, 478-132718, 478-132719,
478-132720, 478-132721, 478-132722, 478-132723, 478-132724, 478-132725,
478-132726, 478-132727, 478-132728, 478-132729, 478-133278, 478-133279,
478-133280, 478-133281, 478-133282, 478-133283, 478-133331, 478-133335,
478-133370, 478-133371, 478-133914, 478-133915, 478-133916, 478-133918,
478-133919, 478-133920, 478-133921, 478-133922, 478-133923, 478-133924,
478-133925, 478-133926, 478-133927, 478-133928, 478-133929, 478-133930,
478-133931, 478-133932, 478-133933, 478-133934, 478-133935, 478-133936,
478-133937, 478-133938, 478-133939, 478-133940, 478-133941, 478-133942,
478-133943, 478-133944, 478-133945, 478-133946, 478-133947, 478-133949,
478-134006, 478-134007, 478-134254, 478-134255, 478-130756, 478-130757,
478-130762, 478-130763, 478-130764, 478-133332, 478-133333, 478-133334,
478-133917, 478-133978, 478-133979, 478-133980, 478-133982, 478-130229,
478-130515, 478-130516, 478-130517, 478-130519, 478-132787, 478-132788,
478-132789, 478-139434, 478-132280, 478-132281, 478-132284, 478-132286,
478-132362, 478-132365, 478-132367, 478-132369, 478-132410, 478-132411,
478-132413, 478-132416, 478-132931, 478-132933, 478-132999, 478-133000,
478-133001, 478-133002, 478-133003, 478-133004, 478-133005, 478-133006,
478-133013, 478-133023, 478-133328, 478-133329, 478-133330, 478-134234,
478-134235, 478-134236, 478-134237, 478-134239, 478-134240, 478-134295,
478-134296, 478-134297, 478-134298, 478-134299, 478-134300, 478-134301,
478-134302, 478-134585, 478-134586, 478-134595, 478-134596, 478-134597,
478-134602, 478-134603, 478-134606, 478-136373, 478-136374, 478-136375,
478-136376, 478-136377, 478-136378, 478-136379, 478-136380, 478-136388,
478-136389, 478-136390, 478-136391, 478-136392, 478-136393, 478-136395,
478-136396, 478-136401, 478-136402, 478-136403, 478-136404, 478-136405,
478-136406, 478-136407, 478-136408, 478-136633, 478-136634, 478-136637,
478-136638, 478-109950, 478-124986, 478-124989, 478-125008, 478-125631,
478-125632, 478-141804, 478-141805, 478-141806, 478-141807, 478-141808,
478-141809, 478-141810, 478-141811, 478-141812, 478-141813, 478-141814,
478-141816, 478-143399, 478-143400, 478-143401, 478-143402, 478-146839,
478-146840, 478-146841, 478-146842, 478-146844, 478-146845, 478-146846,
478-146847, 478-146848, 478-146849, 478-146850, 478-146851, , 478-110624,
478-110968, 478-113052, 478-113053, 478-113090, 478-113091, 478-113092,
478-113093, 478-113094, 478-113111, 478-113112, 478-115377, 478-115395,
478-115397, 478-115400, 478-115402, 478-115404, 478-115405, 478-115417,
478-115418, 478-115419, 478-115420, 478-115422, , 478-113599, 478-113600,
478-117388, 478-117391, 478-118780, 478-118781, 478-118784, 478-118785,
478-122162, 478-122164, , 478-108544, 478-108545, 478-111549, 478-111550,
478-111552, 478-111555, 478-111557, 478-111558, 478-111559, 478-111560,
478-144585, , 478-117158, 478-117804, 478-117805, 478-117806, 478-117807,
478-117808, 478-117809, 478-117810, 478-117811, 478-122542, 478-122543, ,
478-130293, , 478-111709, 478-111858, 478-111859, 478-111860, 478-111861,
478-111862, 478-115005, 478-115334, 478-116340, 478-117533, 478-117534,
478-117535, 478-117536, 478-117537, 478-117538, 478-117764, , 478-117134,
478-118259, 478-118260, 478-119686, 478-122224, 478-122225, 478-122226,
478-122231, , 478-125078, 478-128335, 478-128340, , 478-130301, 478-130882,
478-132238, 478-132248, 478-132268, 478-132282, 478-132285, , 478-109902,
478-109904, 478-109905, 478-109906, 478-109935, 478-109936, 478-110120,
478-110121, 478-110318, 478-110319, 478-111042, 478-111043, , 478-129946,
478-129947, 478-129951, 478-130520, , 478-128333, 478-128545, 478-128546,
478-128547, 478-129165, 478-129168, 478-129169, 478-129172, , 478-108772,
478-108777, 478-108789, 478-108931, 478-108932, 478-108933, 478-108935,
478-108936, 478-108937, 478-108938, 478-108939, 478-111823, 478-111824,
478-111825, 478-111826, 478-115437, 478-115438, 478-111894, 478-111895,
478-111896, 478-111897, 478-142240, 478-142241, 478-142242, 478-142243,
478-143973, 478-143978, 478-146906, 478-146907, 478-146908, 478-146910, ,
478-106050, 478-106063, , 478-110203, 478-110450, 478-110458, 478-110598,
478-115844, 478-116162, 478-116163, 478-116271, 478-122862, 478-122873,
478-122875, 478-122876, 478-136422, 478-136423, 478-136424, 478-136425,
478-136426, 478-136427, 478-136428, 478-136431, 478-145278, 478-145322,
478-145323, 478-145552, 478-146101, 478-146167, 478-146952, 478-147043,
478-147070, 478-147153, 478-147164, 478-147165, , 478-112023, 478-113451,
478-113452, 478-113453, 478-113455, 478-113456, 478-113457, 478-113458,
478-113459, 478-119358, 478-119359, 478-122700, 478-122701, , 478-128338,
478-128339, 478-128341, 478-128342, , 478-112793, 478-112794, 478-116378,
478-124853, 478-126549, 478-126551, 478-126553, 478-126556, 478-126557,
478-126856, 478-126862, 478-126870, 478-126894, , 478-115231, 478-115234,
478-115287, 478-115293, 478-115294, 478-115295, 478-115296, 478-115351,
478-117720, 478-132714, 478-132732, 478-133975, 478-133976, , 478-125684,
478-125687, , 478-116797, 478-116798, , 478-145297, 478-145298, 478-145299,
478-145300, 478-145301, , 478-110493, 478-112048, 478-113096, 478-114216,
478-121458, 478-121459, 478-122161, 478-122165, 478-132730, 478-132731,
478-132733, 478-132734, 478-133326, 478-133327, , 478-141815, 478-142590,
478-142602, , 478-113727, 478-113795, 478-113796, 478-113798, 478-129381,
478-129796, 478-129797, 478-129883, 478-129884, 478-129885, 478-129886,
478-129887, 478-129888, 478-129889, 478-129890, 478-129892, 478-129355,
478-129444, 478-105999, 478-130223, 478-109741, 478-109763, 478-109773,
478-109774, 478-109775, 478-109776, 478-109777, 478-109778, 478-111498,
478-111612, 478-111613, 478-111614, 478-111615, 478-111617, 478-111657,
478-111702, 478-111705, 478-111733, 478-112260, 478-112262, 478-113287,
478-113535, 478-113536, 478-113537, 478-113538, 478-113539, 478-113540,
478-113541, 478-113542, 478-113543, 478-113544, 478-113545, 478-113546,
478-113547, 478-113549, 478-113550, 478-113551, 478-113552, 478-113553,
478-113554, 478-113555, 478-113556, 478-113557, 478-113558, 478-113559,
478-113560, 478-113561, 478-113562, 478-113563, 478-113564, 478-113565,
478-113566, 478-113567, 478-113568, 478-113569, 478-113570, 478-113571,
478-113572, 478-115448, 478-115471, 478-115473, 478-115474, 478-115475,
478-115476, 478-115477, 478-115478, 478-115479, 478-115480, 478-115481,
478-115482, 478-115484, 478-115485, 478-115486, 478-115487, 478-116892,
478-117203, 478-117204, 478-117205, 478-117264, 478-117306, 478-117307,
478-117308, 478-117309, 478-117542, 478-117913, 478-117914, 478-117915,
478-117916, 478-117917, 478-117918, 478-117919, 478-117920, 478-118563,
478-118564, 478-118565, 478-118566, 478-118567, 478-118568, 478-118569,
478-118570, 478-118571, 478-118572, 478-118573, 478-118574, 478-118575,
478-118576, 478-118577, 478-118578, 478-118579, 478-118580, 478-118581,
478-118582, 478-118855, 478-118948, 478-118949, 478-118950, 478-118951,
478-119098, 478-119317, 478-119335, 478-119336, 478-119341, 478-119342,
478-119355, 478-120247, 478-120248, 478-120249, 478-120279, 478-120512,
478-120515, 478-120516, 478-120517, 478-120518, 478-120519, 478-120521,
478-120522, 478-120523, 478-120524, 478-120606, 478-120673, 478-120676,
478-120739, 478-120740, 478-120741, 478-120745, 478-120806, 478-120840,
478-120861, 478-120879, 478-120883, 478-120904, 478-120905, 478-120921,
478-122061, 478-122117, 478-122308, 478-122557, 478-122569, 478-126539,
478-126543, 478-126545, 478-126602, 478-126608, 478-126619, 478-126635,
478-126642, 478-126655, 478-126659, 478-126844, 478-126886, 478-126945,
478-127025, 478-127096, 478-127111, 478-127112, 478-127120, 478-127136,
478-127432, 478-127442, 478-127486, 478-127487, 478-127488, 478-127489,
478-127490, 478-127492, 478-127493, 478-127494, 478-127495, 478-127496,
478-127497, 478-132775, 478-132776, 478-132777, 478-132778, 478-132792,
478-132793, 478-132794, 478-133203, 478-133204, 478-133205, 478-133206,
478-133207, 478-133208, 478-133209, 478-133210, 478-133211, 478-133212,
478-133213, 478-133214, 478-133215, 478-133948, 478-134001, 478-134002,
478-134005, 478-134256, 478-134257, 478-134258, 478-134259, 478-134261,
478-134262, 478-135146, 478-135147, 478-135148, 478-135182, 478-135183,
478-135184, 478-135191, 478-135192, 478-135213, 478-135214, 478-136965,
478-136966, 478-136967, 478-136968, 478-136969, 478-137544, 478-137548,
478-137556, 478-137557, 478-137558, 478-137559, 478-137560, 478-137630,
478-138697, 478-138698, 478-138699, 478-138700, 478-140092, 478-140110,
478-140122, 478-140123, 478-140124, 478-140125, 478-140126, 478-140127,
478-140128, 478-140129, 478-140132, 478-140133, 478-140134, 478-140135,
478-140137, 478-140138, 478-140139, 478-140140, 478-140141, 478-140142,
478-140143, 478-140144, 478-140145, 478-140146, 478-140540, 478-140541,
478-140542, 478-140543, 478-140544, 478-140545, 478-140546, 478-140547,
478-140548, 478-140549, 478-140550, 478-140551, 478-143935, 478-144477,
478-144583, 478-144584, 478-144586, 478-144587, 478-144588, 478-144592,
478-144596, 478-144609, 478-144616, 478-144617, 478-144618, 478-144619,
478-144620, 478-144621, 478-144622, 478-144624, 478-144625, 478-144626,
478-144627, 478-144629, 478-144630, 478-144631, 478-144632, 478-144633,
478-144634, 478-144635, 478-144636, 478-144637, 478-144638, 478-144639,
478-144640, 478-144641, 478-144642, 478-144643, 478-144644, 478-144645,
478-144646, 478-144647, 478-144648, 478-144649, 478-144650, 478-144671,
478-144672, 478-144673, 478-144674, 478-144675, 478-144676, 478-144677,
478-144678, 478-144679, 478-144680, 478-144681, 478-144682, 478-144683,
478-144684, 478-144685, 478-144686, 478-144687, 478-144688, 478-144689,
478-144690, 478-144691, 478-144692, 478-144693, 478-144695, 478-144709,
478-144710, 478-144711, 478-144712, 478-144832, 478-144843, 478-144844,
478-144845, 478-144846, 478-144847, 478-144848, 478-144849, 478-146254,
478-146255, 478-146888, 478-146889, 478-146890, 478-146891, 478-146892,
478-146893, 478-146894, 478-146895, 478-146896, 478-146897, 478-146898,
478-146899, 478-146900, 478-146901, 478-147191, 478-147192, 478-147197,
478-147198, 478-147212, 478-147261, 478-147262, 478-147265, 478-147266,
478-147267, 478-147268, 478-147269, 478-147270, 478-147271, , 478-112404, ,
478-129943, 478-129944, 478-129945, 478-129948, 478-129952, 478-130231,
478-130513, 478-130518, , 478-145035, 478-145363, 478-145616, 478-145617,
478-146203, , 478-106144, 478-110402, 478-110403, 478-110404, 478-110405,
478-112022, 478-112025, 478-112491, , 478-110920, 478-110921, 478-110975,
478-110977, 478-110978, 478-110979, 478-110983, 478-111004, 478-113700,
478-113701, 478-113702, 478-113703, 478-115398, 478-115399, 478-115401,
478-115407, 478-115408, 478-115409, 478-115410, 478-115411, 478-115412,
478-115413, 478-115414, 478-115415, 478-115416, 478-124997, 478-124998,
478-125001, 478-125004, 478-143367, 478-143368, 478-143369, 478-143370, ,
478-110494, 478-110934, 478-110935, 478-127065, , 478-136878, 478-136879,
478-136880, 478-136881, 478-137222, 478-137223, 478-137224, 478-137561,
478-137562, 478-137563, 478-137564, 478-137565, 478-137566, 478-137567,
478-137568, 478-137569, 478-137570, 478-137571, 478-137572, 478-137573,
478-137574, 478-137575, 478-138415, 478-138717, 478-138718, 478-138719,
478-139025, 478-139026, 478-139901, 478-139902, 478-140272, 478-140285,
478-140288, 478-140289, 478-140290, 478-140291, 478-140292, 478-140293,
478-140294, 478-140295, 478-140296, 478-140297, 478-140298, 478-140299,
478-140300, 478-140301, 478-140302, 478-140303, 478-140304, 478-140305,
478-140306, 478-140307, 478-140308, 478-140309, 478-140310, 478-140311,
478-140349, 478-140350, 478-140351, 478-140352, 478-140353, 478-140355,
478-140358, 478-140359, 478-140360, 478-140361, 478-140362, 478-140363,
478-140364, 478-140410, 478-140414, 478-140418, 478-140432, 478-140460,
478-140464, 478-140469, 478-140471, 478-140476, 478-140477, 478-140478,
478-140479, 478-140480, 478-140482, 478-140483, 478-140484, 478-140485,
478-140486, 478-140488, 478-140489, 478-140490, 478-140492, 478-140493,
478-140494, 478-140495, 478-140709, 478-142624, 478-142659, 478-142747,
478-143259, 478-143260, 478-143261, 478-143262, 478-143263, 478-143264,
478-143265, 478-143266, 478-143267, 478-143268, 478-143269, 478-143270,
478-143685, 478-143686, 478-143930, 478-143931, 478-143932, 478-143933,
478-143934, 478-144262, 478-144472, 478-144666, 478-144667, 478-144970,
478-144994, 478-144995, 478-144996, 478-144997, 478-144998, 478-144999,
478-145000, 478-145001, 478-145002, 478-145003, 478-145004, 478-145048,
478-145207, 478-145357, 478-145358, 478-145359, 478-145364, 478-145365,
478-145366, 478-145367, 478-145368, 478-145369, 478-145370, 478-145533,
478-145534, 478-145535, 478-145536, 478-145538, 478-145539, 478-145540,
478-145541, 478-147188, 478-147189, , 478-146936, , 478-118777, 478-118778,
478-118900, 478-118903, 478-118904, 478-118905, 478-118906, 478-118907, ,
478-108843, , 478-127071, 478-127466, , 478-122541, 478-122669, 478-122670,
478-123084, 478-123086, 478-123088, 478-123846, 478-123850, 478-123851,
478-123852, 478-123853, 478-123943, , 478-129143, 478-129144, 478-129145,
478-129146, 478-129148, 478-129149, 478-129155, 478-129156, 478-129158,
478-129162, 478-130567, 478-130570, 478-130571, 478-130572, , 478-126528, ,
478-128769, 478-128770, 478-128771, 478-128772, , 478-130566, , 478-105175,
478-107427, 478-107428, 478-107429, 478-107430, 478-109603, 478-109604,
478-110336, 478-110347, 478-110348, , 478-145321, 478-145360, 478-145361,
478-145362, , 478-142405, , 478-125627, 478-125628, 478-125629, 478-125630, ,
478-129548, 478-129550, , 478-147585, 478-147586, 478-147587, 478-147588, ,
478-120422, 478-124054, 478-124121, 478-124122, 478-124123, 478-124124,
478-124125, 478-124332, 478-124333, 478-124334, 478-124470, 478-124471,
478-124472, 478-124473, 478-124474, 478-124476, 478-124563, 478-124567,
478-124569, 478-128550, 478-128553, 478-128554, , 478-111119, , 478-100466,
478-107417, 478-107418, 478-107420, 478-107426, 478-107790, 478-107791,
478-107792, 478-107793, 478-107843, 478-108790, 478-108794, 478-108799,
478-108814, 478-108815, 478-108840, 478-108841, 478-108876, 478-108877,
478-108878, 478-119096, 478-119333, 478-120423, 478-121450, 478-121454,
478-122166, 478-124475, 478-124477, 478-124479, 478-124565, 478-124566,
478-128024, 478-128334, 478-129689, , 478-130759, 478-140374, 478-140710,
478-140731, 478-140732, 478-141143, 478-141144, 478-141145, 478-141146,
478-141578, 478-141579, 478-141580, 478-141581, 478-141582, 478-141583,
478-141584, 478-141585, 478-143624, 478-143625, 478-143626, 478-143627,
478-143628, 478-143629, 478-143630, 478-143631, 478-143632, 478-143633,
478-145637, 478-145638, 478-145639, 478-145640, 478-145641, 478-145642,
478-145643, 478-145644, 478-145645, 478-145646, 478-146919, 478-146920,
478-146921, 478-146922, 478-146923, 478-146924, 478-146925, 478-146926,
478-146927, 478-146928, , 478-111041, 478-125079, 478-125083, 478-125084,
478-125666, 478-125683, 478-125685, 478-125686, 478-125688, 478-125689,
478-126674, 478-126675, 478-126678, 478-128549, 478-128658, 478-128659,
478-128660, 478-128663, 478-128664, 478-129163, 478-129164, 478-129166,
478-129170, 478-129171, 478-129683, 478-129685, 478-129686, 478-129688,
478-129690, 478-129692, , 478-122109, 478-126251, 478-126262, 478-126270,
478-126271, 478-126275, 478-126280, 478-126282, 478-126284, 478-126285, ,
478-128768, 478-129147, 478-129150, 478-129151, , 478-130224, 478-130225, ,
478-144421, 478-144422, 478-145026, 478-145028, 478-145029, 478-145030,
478-145031, 478-145032, 478-145033, 478-145034, 478-145036, 478-145037,
478-145038, 478-145039, 478-145040, , 478-125011, 478-125012, 478-125013,
478-125014, 478-128873, 478-128874, 478-128875, 478-128876, 478-128877,
478-128878, 478-128879, 478-128880, 478-128881, 478-128882, 478-128883,
478-128884, 478-128885, 478-128886, 478-128887, 478-128888, 478-128889,
478-128890, 478-128891, 478-128892, 478-129314, 478-129679, 478-129814,
478-129821, 478-133989, 478-133990, 478-133991, 478-133992, 478-133993,
478-133994, 478-133995, 478-133996, 478-133997, 478-133998, 478-133999,
478-134000, 478-138407, 478-138408, 478-138409, 478-138410, 478-138411,
478-138412, 478-138413, 478-138414, 478-139033, 478-139035, 478-139037,
478-139038, 478-139039, 478-139040, 478-139041, 478-139042, 478-139056,
478-139057, 478-139157, 478-139158, 478-139160, 478-139161, 478-139162,
478-139163, 478-139165, 478-139166, 478-139167, 478-139168, 478-139169,
478-139170, 478-139171, 478-139172, 478-139173, 478-139174, 478-139175,
478-139176, 478-139178, 478-139179, 478-139180, 478-139181, 478-139190,
478-139191, 478-139192, 478-139193, 478-139194, 478-139195, 478-139196,
478-139197, 478-139198, 478-139199, 478-139200, 478-139201, 478-139202,
478-139203, 478-139204, 478-139205, 478-139206, 478-139207, 478-139208,
478-139209, 478-139210, 478-139211, 478-139212, 478-139213, 478-139214,
478-139215, 478-139216, 478-139217, 478-139218, 478-139219, 478-139220,
478-139221, 478-141989, 478-142793, 478-142806, 478-142807, 478-142808,
478-142816, 478-142831, 478-143576, 478-143579, 478-143580, 478-143583,
478-143714, 478-143715, 478-143716, 478-143717, 478-143718, 478-143719,
478-143720, 478-143721, 478-143722, 478-144786, 478-144787, 478-144788,
478-144790, 478-144791, 478-144792, 478-144793, 478-144796, , 478-125077,
478-125633, 478-125634, 478-125635, 478-125636, , 478-110118, 478-110119, ,
478-112429, 478-112809, 478-112810, 478-112811, 478-112812, 478-112884,
478-112984, 478-112985, 478-112986, 478-112987, 478-112988, 478-112989,
478-116703, 478-118097, 478-118098, , 478-108601, 478-108695, 478-108696,
478-108697, 478-110931, 478-110957, 478-111007, 478-111008, 478-114058,
478-114059, 478-114060, 478-114061, 478-114095, 478-114096, 478-114097,
478-114098, 478-115216, 478-115218, 478-115222, 478-115224, 478-115227,
478-115228, 478-115275, 478-115938, 478-115939, 478-115940, 478-116075,
478-116076, 478-116077, 478-116242, 478-116649, 478-116722, 478-116897,
478-117437, 478-117628, 478-117629, 478-117630, 478-117631, 478-117632,
478-117633, 478-117634, 478-117635, 478-117636, 478-118839, 478-118844,
478-118845, 478-119976, 478-119979, 478-119980, 478-120667, 478-120668,
478-120675, 478-120677, 478-120678, 478-122686, 478-122694, , 478-126537,
478-126541, 478-126542, 478-126544, , 478-100256, 478-100261, 478-100349,
478-100361, 478-100364, 478-101426, 478-101445, 478-105355, 478-106408,
478-106413, 478-106414, 478-106419, 478-106852, 478-106891, 478-106896,
478-106897, 478-107050, 478-107083, 478-107084, 478-107085, 478-107133,
478-107134, 478-107379, 478-107380, 478-107381, 478-107382, 478-107385,
478-107386, 478-107387, 478-107389, 478-108140, 478-108593, 478-108614,
478-108616, 478-108771, 478-109362, 478-109364, 478-109365, 478-109383,
478-109384, 478-109385, 478-109927, 478-109928, 478-110663, 478-110693,
478-110743, 478-110748, 478-110786, 478-110787, 478-110788, 478-110791,
478-110793, 478-110794, 478-110795, 478-110796, 478-110824, 478-110825,
478-110829, 478-110830, 478-110901, 478-110902, 478-110903, 478-110904,
478-111065, 478-111066, 478-111067, 478-111068, 478-111139, 478-111140,
478-111141, 478-111142, 478-111262, 478-111263, 478-111286, 478-111296,
478-111611, 478-111921, 478-111922, 478-111923, 478-112423, 478-112424,
478-112425, 478-112523, 478-112528, 478-112529, 478-112530, 478-112531,
478-112532, 478-112533, 478-112534, 478-112535, 478-112655, 478-112683,
478-112684, 478-112685, 478-112686, 478-112687, 478-112795, 478-112796,
478-113212, 478-113213, 478-113214, 478-113215, 478-113293, 478-113294,
478-113295, 478-113296, 478-113393, 478-113394, 478-113395, 478-113396,
478-114377, 478-114378, 478-114510, 478-114511, 478-114779, 478-114780,
478-114781, 478-114782, 478-114783, 478-114784, 478-114786, 478-114787,
478-114899, 478-114903, 478-114905, 478-114906, 478-114922, 478-114924,
478-114926, 478-114927, 478-114928, 478-114929, 478-114930, 478-114931,
478-114932, 478-114933, 478-114934, 478-114935, 478-115289, 478-115290,
478-115291, 478-115292, 478-115428, 478-115454, 478-115455, 478-115456,
478-115457, 478-115458, 478-115461, 478-115462, 478-115604, 478-115605,
478-115629, 478-115630, 478-115763, 478-115783, 478-116093, 478-116094,
478-116095, 478-116390, 478-116457, 478-116546, 478-116847, 478-116854,
478-116937, 478-116940, 478-116976, 478-116981, 478-117206, 478-117207,
478-117208, 478-117263, 478-117275, 478-117279, 478-117280, 478-117281,
478-117282, 478-117283, 478-117284, 478-117285, 478-117286, 478-117693,
478-117694, 478-117700, 478-117701, 478-117702, 478-117703, 478-117711,
478-117879, 478-117929, 478-117933, 478-117934, 478-117935, 478-117936,
478-117952, 478-118000, 478-118001, 478-118002, 478-118003, 478-118004,
478-118006, 478-118009, 478-118067, 478-118068, 478-118069, 478-118070,
478-118085, 478-118086, 478-118087, 478-118088, 478-118466, 478-118467,
478-118468, 478-118469, 478-118470, 478-118471, 478-118846, 478-118849,
478-118850, 478-118851, 478-118852, 478-118853, 478-119049, 478-119055,
478-119067, 478-119068, 478-119200, 478-119201, 478-119204, 478-119205,
478-119206, 478-119207, 478-119208, 478-119209, 478-119210, 478-119212,
478-119220, 478-119223, 478-119421, 478-119422, 478-119457, 478-119462,
478-119463, 478-119478, 478-119480, 478-119483, 478-119485, 478-119486,
478-119487, 478-119488, 478-119489, 478-119493, 478-119712, 478-119739,
478-119888, 478-119897, 478-119917, 478-119928, 478-119929, 478-119931,
478-119932, 478-119933, 478-119936, 478-119939, 478-119940, 478-119941,
478-119951, 478-119952, 478-119953, 478-119954, 478-119955, 478-119956,
478-119957, 478-119958, 478-119968, 478-119969, 478-119970, 478-119971,
478-119972, 478-119973, 478-119974, 478-119975, 478-119977, 478-119978,
478-119981, 478-119983, 478-119994, 478-119995, 478-119996, 478-120008,
478-120012, 478-120013, 478-120016, 478-120017, 478-120018, 478-120021,
478-120030, 478-120456, 478-120461, 478-120467, 478-120480, 478-120481,
478-120483, 478-120484, 478-120485, 478-120497, 478-120498, 478-120500,
478-120572, 478-120578, 478-120582, 478-120583, 478-120584, 478-120585,
478-120586, 478-120587, 478-120588, 478-120589, 478-120590, 478-120591,
478-120592, 478-120593, 478-120594, 478-120595, 478-120596, 478-120597,
478-120622, 478-120623, 478-120624, 478-120625, 478-120626, 478-120627,
478-120634, 478-120635, 478-120636, 478-120637, 478-120644, 478-120725,
478-120755, 478-120759, 478-120772, 478-120773, 478-120797, 478-120803,
478-120808, 478-121637, 478-121705, 478-121706, 478-121754, 478-121763,
478-121773, 478-121909, 478-121912, 478-121913, 478-121922, 478-121925,
478-122003, 478-122004, 478-122008, 478-122009, 478-122010, 478-122065,
478-122066, 478-122113, 478-122248, 478-122270, 478-122272, 478-122293,
478-122336, 478-122349, 478-122383, 478-122578, 478-122723, 478-122724,
478-122725, 478-122736, 478-122755, 478-123303, 478-123325, 478-123326,
478-123328, 478-123329, 478-123330, 478-123366, 478-123466, 478-123467,
478-123483, 478-124924, 478-125099, 478-125109, 478-125110, 478-125116,
478-125126, 478-125142, 478-125170, 478-125193, 478-125227, 478-125228,
478-125249, 478-125524, 478-125533, 478-125534, 478-125538, 478-125553,
478-125600, 478-125604, 478-125617, 478-125618, 478-125620, 478-125626,
478-125651, 478-126036, 478-126044, 478-126051, 478-126081, 478-126096,
478-126097, 478-126098, 478-126099, 478-126687, 478-126690, 478-126691,
478-127632, 478-134003, 478-134004, 478-134476, 478-136501, 478-136502,
478-136503, 478-136504, 478-136505, 478-136506, 478-136507, 478-136508,
478-136509, 478-136510, 478-136511, 478-136512, 478-136513, 478-136514,
478-136515, 478-136516, 478-136517, 478-136518, 478-136519, 478-136520,
478-136521, 478-136522, 478-136523, 478-136524, 478-136563, 478-136564,
478-137414, 478-139044, 478-139045, 478-139046, 478-139047, 478-139048,
478-139049, 478-139050, 478-139051, 478-139052, 478-139053, 478-139054,
478-139055, 478-139368, 478-139373, 478-139410, 478-139412, 478-139609,
478-139611, 478-139612, 478-139613, 478-139688, 478-139690, 478-139691,
478-139692, 478-139862, 478-139864, 478-139865, 478-139866, 478-139867,
478-139868, 478-139869, 478-139870, 478-139903, 478-139904, 478-139905,
478-139906, 478-139907, 478-139908, 478-139909, 478-139910, 478-139911,
478-139912, 478-139913, 478-139914, 478-139915, 478-139916, 478-139917,
478-139918, 478-140189, 478-140199, 478-140241, 478-140255, 478-140256,
478-140257, 478-140258, 478-140259, 478-140260, 478-140261, 478-140262,
478-140263, 478-140264, 478-140265, 478-140266, 478-140267, 478-140268,
478-140269, 478-140270, 478-140271, 478-140275, 478-140276, 478-140277,
478-140278, 478-140279, 478-140280, 478-140281, 478-140283, 478-140284,
478-140287, 478-140312, 478-140313, 478-140314, 478-140315, 478-140316,
478-140317, 478-140318, 478-140319, 478-140320, 478-140366, 478-140685,
478-140686, 478-140687, 478-140688, 478-141498, 478-141676, 478-141745,
478-141746, 478-141747, 478-141748, 478-141749, 478-141750, 478-141752,
478-141753, 478-141754, 478-141755, 478-141757, 478-141759, 478-141760,
478-141761, 478-141762, 478-141763, 478-141764, 478-141765, 478-141766,
478-141767, 478-141768, 478-141769, 478-141770, 478-141771, 478-141772,
478-141773, 478-141774, 478-141775, 478-142080, 478-142098, 478-142112,
478-142187, 478-142198, 478-142199, 478-142200, 478-142201, 478-142202,
478-142203, 478-142204, 478-142205, 478-142206, 478-142207, 478-142208,
478-142209, 478-142218, 478-142221, 478-142222, 478-142237, 478-142238,
478-142251, 478-142252, 478-142253, 478-142254, 478-142255, 478-142257,
478-142258, 478-142259, 478-142260, 478-142261, 478-142262, 478-142263,
478-142264, 478-142320, 478-142321, 478-142323, 478-142325, 478-142326,
478-142336, 478-142338, 478-142339, 478-142340, 478-142341, 478-142342,
478-142343, 478-142346, 478-142347, 478-142348, 478-142349, 478-142350,
478-142351, 478-142352, 478-142353, 478-142354, 478-142355, 478-142356,
478-142357, 478-142358, 478-142359, 478-142360, 478-142361, 478-142362,
478-142363, 478-142364, 478-142365, 478-142366, 478-142367, 478-142404,
478-142406, 478-142407, 478-142408, 478-142409, 478-142410, 478-142411,
478-142412, 478-142413, 478-142414, 478-142415, 478-142416, 478-142417,
478-142418, 478-142419, 478-142420, 478-142421, 478-142540, 478-142541,
478-142542, 478-142543, 478-142544, 478-142545, 478-142546, 478-142804,
478-142817, 478-142818, 478-142820, 478-142821, 478-142836, 478-142861,
478-142899, 478-142920, 478-142921, 478-142922, 478-142923, 478-143045,
478-143046, 478-143047, 478-143048, 478-143049, 478-143050, 478-143054,
478-143056, 478-143057, 478-143058, 478-143059, 478-143077, 478-143078,
478-143079, 478-143080, 478-143144, 478-143145, 478-143146, 478-143147,
478-143148, 478-143359, 478-143360, 478-143361, 478-143362, 478-143363,
478-143364, 478-143365, 478-143366, 478-143371, 478-143372, 478-143420,
478-143421, 478-143422, 478-143423, 478-143424, 478-143425, 478-143426,
478-143427, 478-143428, 478-143429, 478-143430, 478-143431, 478-143725,
478-143726, 478-143727, 478-143728, 478-143983, 478-143986, 478-144001,
478-144008, 478-144009, 478-144010, 478-144012, 478-144013, 478-144185,
478-144205, 478-144224, 478-144469, 478-144568, 478-144570, 478-144612,
478-144613, 478-144614, 478-144716, 478-144717, 478-144718, 478-144719,
478-144764, 478-144765, 478-144766, 478-144767, 478-144885, 478-144886,
478-144887, 478-144888, 478-144889, 478-144890, 478-144891, 478-144892,
478-144901, 478-145117, 478-145118, 478-145119, 478-145120, 478-145121,
478-145818, 478-145819, 478-145828, 478-145831, 478-145861, 478-145862,
478-145863, 478-145864, 478-145865, 478-145866, 478-145867, 478-145868,
478-145869, 478-145870, 478-145871, 478-145872, 478-145873, 478-145876,
478-145989, 478-146133, 478-146134, 478-146135, 478-146136, 478-146248,
478-146326, 478-146327, 478-146328, 478-146329, 478-146330, 478-146331,
478-146332, 478-146333, 478-146334, 478-146335, 478-146336, 478-146337,
478-146338, 478-146339, 478-146736, 478-146787, 478-147334, 478-147394,
478-147395, 478-147396, , 478-105280, 478-105976, 478-105977, 478-105996,
478-105997, 478-105998, 478-106003, 478-106004, 478-106074, 478-106075,
478-106505, 478-109829, 478-109830, 478-109831, 478-109832, 478-110626,
478-111175, 478-112024, 478-112037, 478-112039, 478-112041, 478-112494,
478-112495, 478-112500, 478-113109, 478-116877, 478-116888, 478-116889,
478-117079, 478-118040, 478-139752, 478-143282, 478-143283, 478-143284,
478-143285, 478-143286, 478-143287, 478-143693, 478-143694, 478-143695,
478-143696, 478-143697, 478-143698, 478-144037, 478-144038, 478-146207,
478-146210, , 478-105979, 478-105981, 478-105982, 478-105983, 478-105984,
478-105985, 478-105986, 478-105987, 478-106170, 478-106171, 478-106172,
478-106173, 478-106174, 478-106179, 478-107338, 478-107339, 478-107340,
478-107341, 478-107342, 478-107343, 478-107344, 478-107345, 478-107346,
478-107347, 478-107348, 478-107555, 478-107556, 478-107557, 478-107619,
478-107620, 478-107621, 478-107679, 478-107680, 478-107681, 478-107736,
478-108103, 478-108104, 478-108105, 478-108106, 478-108107, 478-108108,
478-109048, 478-109065, 478-109066, 478-109067, 478-110114, 478-110115,
478-110127, 478-110128, 478-110129, 478-110130, 478-110131, 478-110132,
478-110133, 478-110134, 478-110135, 478-110136, 478-110186, 478-110187,
478-110188, 478-110189, 478-110190, 478-110191, 478-110239, 478-110240,
478-110290, 478-110701, 478-110702, 478-110703, 478-110770, 478-110771,
478-110772, 478-110839, 478-110840, 478-110841, 478-111040, 478-111165,
478-111166, 478-111167, 478-111168, 478-111169, 478-111170, 478-111171,
478-111172, 478-111173, 478-111174, 478-111309, 478-111310, 478-111311,
478-111312, 478-111313, 478-111314, 478-111315, 478-111316, 478-111317,
478-111318, 478-111319, 478-111320, 478-111321, 478-111322, 478-111323,
478-111324, 478-111325, 478-111326, 478-111327, 478-111328, 478-111329,
478-111330, 478-111331, 478-111332, 478-111333, 478-111334, 478-111335,
478-111336, 478-111337, 478-111338, 478-113001, 478-113002, 478-113003,
478-113004, 478-113005, 478-113009, 478-113011, 478-113012, 478-113013,
478-113014, 478-113015, 478-113016, 478-113017, 478-113018, 478-113019,
478-113020, 478-113021, 478-113022, 478-113023, 478-113024, 478-113025,
478-113026, 478-113027, 478-113028, 478-113029, 478-113030, 478-113601,
478-113602, 478-113603, 478-113801, 478-113802, 478-113803, 478-113804,
478-113805, 478-113862, 478-113863, 478-113864, 478-113865, 478-113866,
478-113867, 478-113868, 478-113869, 478-113870, 478-113871, 478-113872,
478-113873, 478-113874, 478-113875, 478-113876, 478-113877, 478-113878,
478-113879, 478-115352, 478-115353, 478-115354, 478-115355, 478-115356,
478-115357, 478-115359, 478-115360, 478-115361, 478-115362, 478-115363,
478-115364, 478-115365, 478-115366, 478-115367, 478-115368, 478-115369,
478-115370, 478-115371, 478-115372, 478-115373, 478-115374, 478-115375,
478-115376, 478-116445, 478-116451, 478-116452, 478-116453, 478-117049,
478-117146, 478-117147, 478-117148, 478-117149, 478-117150, 478-117151,
478-117152, 478-117153, 478-117154, 478-117155, 478-117156, 478-117157,
478-117159, 478-117160, 478-117161, 478-117162, 478-117163, 478-117164,
478-117165, 478-117166, 478-117167, 478-117168, 478-117169, 478-117170,
478-118273, 478-118274, 478-118333, 478-118334, 478-118335, 478-118336,
478-118337, 478-118338, 478-118339, 478-118340, 478-118341, 478-118342,
478-118343, 478-118344, 478-118345, 478-118346, 478-118347, 478-118348,
478-118349, 478-118350, 478-118749, 478-118750, 478-118751, 478-118752,
478-118753, 478-118754, 478-118755, 478-118756, 478-118757, 478-118758,
478-118759, 478-118760, 478-118762, 478-118763, 478-118765, 478-118766,
478-118767, 478-118768, 478-118769, 478-118770, 478-118771, 478-118772,
478-118773, 478-118901, 478-118902, 478-118908, 478-118909, 478-122328,
478-122534, 478-122536, 478-122671, 478-122673, 478-122674, 478-122675,
478-122676, 478-122677, 478-122907, 478-122908, 478-122910, 478-122911,
478-122912, 478-123845, 478-123942, 478-124041, 478-124043, 478-124044,
478-124045, 478-124046, 478-124047, 478-124048, 478-134655, 478-134656,
478-134657, 478-134658, 478-134659, 478-134660, 478-134661, 478-134662,
478-141217, 478-141218, 478-141219, 478-141220, 478-141221, 478-141222,
478-141223, 478-141224, 478-141983, 478-141984, 478-142223, 478-142224,
478-142225, 478-142226, 478-142227, 478-142649, 478-142650, 478-142651,
478-143278, 478-143279, 478-143280, 478-143281, 478-143447, 478-143448,
478-143449, 478-143450, 478-143687, 478-143688, 478-143689, 478-143690,
478-143927, 478-143928, 478-143929, 478-143970, 478-143971, 478-143972,
478-143974, 478-143975, 478-143976, 478-143977, 478-143979, 478-147294,
478-147295, , 478-106825, 478-133977, 478-133981, 478-133983, 478-133984,
478-133985, 478-133986, 478-133987, 478-133988, 478-137692, 478-139189,
478-139614, 478-139615, 478-139616, 478-139617, 478-139618, 478-139619,
478-139620, 478-139621, 478-139622, 478-139623, 478-140408, 478-140552,
478-140733, 478-141450, 478-141451, 478-141452, 478-141453, 478-141454,
478-141455, 478-141557, 478-142565, 478-142566, 478-142567, 478-142568,
478-142569, 478-143691, 478-143692, 478-144928, 478-144929, 478-144930,
478-144931, 478-144932, 478-144933, 478-144934, 478-144935, 478-144936,
478-145112, 478-145113, 478-146515, 478-146516, 478-146517, 478-146518,
478-146519, 478-146520, 478-146719, 478-146720, 478-146721, 478-146929,
478-146930, 478-146931, 478-146932, 478-146933, 478-146934, , 478-105988,
478-105989, 478-105990, 478-105991, 478-106006, 478-106007, 478-106506,
478-106997, 478-106998, 478-107421, 478-107934, 478-108222, 478-108223,
478-108224, 478-108225, 478-108226, 478-109068, 478-109155, 478-109156,
478-109157, 478-109158, 478-109334, 478-109335, 478-109336, 478-109337,
478-109338, 478-109339, 478-109340, 478-109341, 478-109665, 478-109666,
478-109667, 478-109668, 478-110125, 478-110999, 478-111181, 478-111182,
478-112026, 478-112028, 478-112029, 478-112030, 478-112031, 478-112032,
478-112033, 478-112034, 478-112035, 478-112038, 478-112042, 478-112043,
478-112045, 478-112051, 478-112476, 478-112480, 478-112481, 478-112482,
478-112483, 478-112484, 478-112485, 478-112486, 478-112487, 478-112488,
478-112489, 478-112496, 478-112497, 478-112499, 478-113031, 478-113033,
478-113037, 478-113038, 478-113039, 478-113040, 478-113041, 478-113042,
478-113043, 478-113044, 478-113045, 478-113049, 478-113100, 478-113104,
478-113105, 478-113106, 478-113107, 478-113108, 478-113110, 478-113113,
478-114222, 478-115387, 478-115392, 478-115394, 478-115396, 478-116789,
478-116791, 478-116792, 478-116793, 478-116794, 478-116795, 478-116796,
478-116807, 478-116809, 478-116826, 478-116829, 478-117119, 478-117120,
478-117121, 478-117125, 478-117128, 478-117133, 478-117135, 478-117137,
478-117138, 478-117139, 478-117140, 478-117141, 478-117142, 478-117143,
478-119325, 478-119680, 478-119681, 478-119682, 478-119683, 478-119684,
478-119685, 478-119687, 478-119688, 478-119689, 478-120416, 478-120417,
478-120418, 478-120419, 478-120420, 478-120421, 478-120424, 478-121451,
478-121452, 478-121453, 478-121455, 478-121456, 478-121457, 478-124053,
478-124129, 478-124130, 478-124325, 478-124326, 478-124327, 478-124328,
478-124329, 478-124330, 478-124564, 478-124981, 478-124982, 478-124983,
478-124991, 478-124993, 478-124995, 478-125002, 478-125003, 478-125005,
478-125006, 478-125007, 478-125009, 478-125010, 478-125065, 478-125066,
478-125067, 478-125068, 478-125080, 478-126676, 478-126677, 478-128023,
478-128025, 478-128026, 478-128027, 478-129950, 478-130226, 478-130227,
478-130228, 478-130230, 478-130232, 478-130514, 478-130521, 478-130522,
478-130754, 478-130755, 478-130765, 478-131979, 478-132780, 478-132781,
478-132782, 478-140375, 478-140376, 478-140531, 478-140532, 478-140533,
478-140534, 478-140535, 478-140536, 478-140537, 478-140538, 478-140899,
478-140900, 478-141076, 478-141077, 478-141108, 478-141109, 478-141110,
478-141111, 478-141112, 478-141113, 478-141114, 478-141115, 478-141116,
478-141117, 478-141118, 478-141119, 478-141120, 478-141121, 478-141122,
478-143034, 478-143035, 478-143036, 478-143037, 478-143038, 478-143039,
478-143040, 478-143041, 478-143051, 478-143052, 478-143563, 478-143564,
478-143565, 478-143566, 478-144177, 478-144178, 478-144179, 478-144180,
478-144181, 478-144182, 478-144183, 478-144184, 478-144186, 478-144187,
478-144188, 478-144189, 478-144190, 478-144191, 478-144192, 478-144193,
478-144194, 478-144195, 478-144196, 478-144197, 478-144198, 478-144199,
478-144201, 478-144202, 478-144203, 478-144204, 478-144206, 478-144207,
478-144208, 478-144209, 478-144210, 478-144211, 478-144212, 478-144213,
478-144214, 478-144215, 478-144216, 478-144217, 478-144218, 478-144219,
478-144220, 478-144221, 478-144222, 478-144223, 478-144225, 478-144226,
478-144227, 478-144228, 478-144229, 478-144230, 478-144231, 478-144232,
478-144233, 478-144234, 478-144235, 478-144236, 478-144237, 478-144238,
478-144239, 478-144240, 478-144241, 478-144242, 478-144243, 478-144244,
478-144245, 478-144246, 478-144247, 478-144248, 478-144249, 478-144250,
478-144264, 478-145553, 478-145554, 478-145615, 478-145647, 478-145924,
478-146053, 478-146054, 478-146055, 478-146056, 478-146057, 478-146107,
478-146129, 478-146130, 478-146131, 478-146132, 478-146204, 478-146205,
478-146206, 478-146265, 478-146283, 478-146397, 478-146403, 478-146426,
478-146453, 478-146462, 478-1466911, 478-1466912, 478-1466913, 478-1466914,
478-1466915, 478-1466916, 478-146917, 478-146918, 478-100075, 478-100250,
478-111102, 478-111103, 478-112071, 478-112847, 478-112848, 478-112849,
478-112850, 478-112851, 478-112852, 478-112853, 478-112854, 478-112855,
478-112894, 478-112895, 478-112896, 478-112897, 478-112898, 478-112899,
478-112900, 478-112901, 478-112902, 478-112903, 478-112904, 478-112905,
478-112906, 478-112907, 478-114666, 478-116219, 478-122727, 478-125119, ,
478-109954, 478-109955, 478-109956, 478-109957, 478-109958, 478-109959,
478-112631, 470-112426, 478-100366, 478-101160, 478-101556, 478-105117,
478-105237, 478-106022, 478-106031, 478-106090, 478-106097, 478-106194,
478-106263, 478-106422, 478-106426, 478-106583, 478-106593, 478-106602,
478-106614, 478-106615, 478-106622, 478-106624, 478-106625, 478-106630,
478-106634, 478-107101, 478-107103, 478-107469, 478-107470, 478-107471,
478-107472, 478-108020, 478-108021, 478-108022, 478-108023, 478-108024,
478-108025, 478-108958, 478-108959, 478-108960, 478-108967, 478-109027,
478-109934, 478-110041, 478-110042, 478-110043, 478-110044, 478-110045,
478-110046, 478-110047, 478-110048, 478-110049, 478-110050, 478-110051,
478-110576, 478-111071, 478-111121, 478-111122, 478-111123, 478-111124,
478-111125, 478-111127, 478-111129, 478-111711, 478-112015, 478-112147,
478-112427, 478-112559, 478-112569, 478-112570, 478-112571, 478-112572,
478-112611, 478-112612, 478-112613, 478-112621, 478-112622, 478-112623,
478-112638, 478-112639, 478-112756, 478-112757, 478-112758, 478-112759,
478-112760, 478-112761, 478-112762, 478-112763, 478-112765, 478-112766,
478-112767, 478-112781, 478-112782, 478-112783, 478-112784, 478-112785,
478-112786, 478-112787, 478-112788, 478-112789, 478-112790, 478-112791,
478-112792, 478-112797, 478-112798, 478-112799, 478-112800, 478-112808,
478-112826, 478-112827, 478-112828, 478-112845, 478-112846, 478-113210,
478-113211, 478-113582, 478-113669, 478-113762, 478-113763, 478-113765,
478-113766, 478-113767, 478-113768, 478-113769, 478-113770, 478-113771,
478-113779, 478-113785, 478-113788, 478-113790, 478-114023, 478-114025,
478-114134, 478-114135, 478-114220, 478-114364, 478-114365, 478-114366,
478-114368, 478-114369, 478-114370, 478-114371, 478-114372, 478-114373,
478-114374, 478-114375, 478-114399, 478-114400, 478-114401, 478-114402,
478-114443, 478-114506, 478-114507, 478-114508, 478-114509, 478-114585,
478-114587, 478-114588, 478-114595, 478-114628, 478-114633, 478-114635,
478-114664, 478-114686, 478-114687, 478-114688, 478-114689, 478-114691,
478-115083, 478-115084, 478-115085, 478-115086, 478-116335, 478-116790,
478-116799, 478-116800, 478-116801, 478-116802, 478-116803, 478-116804,
478-116805, 478-116806, 478-116808, 478-116811, 478-116812, 478-116813,
478-116814, 478-116815, 478-116816, 478-116818, 478-116819, 478-116820,
478-116821, 478-116822, 478-116823, 478-116825, 478-117123, 478-117124,
478-117129, 478-117130, 478-117131, 478-117132, 478-117136, 478-117310,
478-117316, 478-118037, 478-118038, 478-118039, 478-118043, 478-118044,
478-118045, 478-118046, 478-118251, 478-118252, 478-118253, 478-118254,
478-118255, 478-118257, 478-118258, 478-118858, 478-119982, 478-120449,
478-120468, 478-120478, 478-120479, 478-122118, 478-122119, 478-122309,
478-122690, 478-122707, 478-122708, 478-122709, 478-122743, 478-124305,
478-124313, 478-124314, 478-124317, 478-124319, 478-124324, 478-127066,
478-128472, 478-128485, 478-128501, 478-128503, 478-128511, 478-128512,
478-128541, 478-129459, 478-129603, 478-129616, 478-129619, 478-129642,
478-129643, 478-130688, 478-130748, 478-125081, 478-125082, 478-109079,
478-110974, 478-112046, 478-113034, 478-113035, 478-113046, 478-113047,
478-113048, 478-113054, 478-113055, 478-113095, 478-113102, 478-113103,
478-114219, 478-114223, 478-114225, 478-115378, 478-115379, 478-115380,
478-115382, 478-115389, 478-116827, 478-116828, 478-116830, 478-116831,
478-118042, 478-122160, 478-122167, 478-124050, 478-124051, 478-124052,
478-124056, 478-124478, 478-124572, 478-124984, 478-124985, 478-124987,
478-124990, 478-124992, 478-124999, 478-125000, 478-125073, 478-125074,
478-125075, 478-125076, 478-106175, 478-106181, 478-106183, 478-128524,
478-129152, 478-127063, 478-127078, 478-128745, 478-130071, 478-130304,
478-130305, 478-130359, 478-146058, 478-146059, 478-130564, 478-130565,
478-130568, 478-130569, 478-120326, 478-120470, 478-120471, 478-120472,
478-120475, 478-120486, 478-120490, 478-120493, 478-120495, 478-122689,
478-118544, 478-119360, 478-122342, 478-124306, 478-124307, 478-124308,
478-124309, 478-124315, 478-124316, 478-124318, 478-124321, 478-124322,
478-124323, 478-126427, 478-126431, 478-126434, 478-126660, 478-127449,
478-127757, 478-127758, 478-127855, 478-128298, 478-128469, 478-128543,
478-128544, 478-109114, 478-116014, 478-116015, 478-116676, 478-118332,
478-122296, 478-122297, 478-122299, 478-122300, 478-122301, 478-122302,
478-122303, 478-122311, 478-122376, 478-122378, 478-128354, 478-128400,
478-128426, 478-128475, 478-127579, 478-128266, 478-110558, 478-122295,
478-122316, 478-130366, 478-132101, 478-132102, 478-132103, 478-132104,
478-127072, , 478-111194, 478-111211, 478-111266, 478-111267, 478-105379, ,
478-108390, 478-108391, 478-110666, 478-110668, 478-110678, 478-110681,
478-110683, 478-110717, 478-110722, 478-110724, 478-110730, 478-110733,
478-110738, 478-110967, 478-111012, , 478-100055, 478-100377, 478-100437,
478-101115, 478-101144, 478-106394, 478-108846, 478-108856, 478-108857,
478-108869, 478-108870, 478-108874, 478-108875, 478-108879, 478-108882,
478-108885, 478-108891, 478-108892, 478-108893, 478-108895, 478-108921,
478-108922, 478-108941, 478-108942, 478-108944, 478-108946, 478-108947,
478-108955, 478-108956, 478-108957, 478-119332, 478-119349, 478-131047,
478-131073, 478-131074, 478-131098, 478-131102, 478-131118, 478-133446,
478-133447, 478-133448, 478-133449, 478-133450, 478-133451, 478-133452,
478-133453, 478-133454, 478-133455, 478-133456, 478-133457, 478-133458,
478-133459, 478-133460, 478-133479, 478-133480, 478-133481, 478-133482,
478-133483, 478-133484, 478-133485, 478-133486, 478-133487, 478-133488,
478-133489, 478-133490, 478-133491, 478-133492, 478-133493, 478-133494,
478-133495, 478-133496, 478-133497, 478-133498, 478-133499, 478-133500,
478-133501, 478-133503, 478-133504, 478-140502, 478-140503, 478-140504,
478-140505, 478-140506, 478-140507, 478-140508, 478-140509, 478-140510,
478-140511, 478-143339, 478-143340, 478-143341, 478-143342, 478-144082,
478-144089, 478-144090, 478-144091, 478-144092, 478-144093, 478-144094,
478-144095, 478-144097, 478-144099, , 478-117513, 478-117516, 478-117529,
478-117530, 478-117531, 478-117532, 478-117768, 478-117769, 478-117771,
478-117774, 478-117778, 478-117779, , 478-107858, 478-111152, 478-111339,
478-111340, 478-111351, 478-111353, 478-111354, 478-111355, 478-118463,
478-118464, 478-118465, 478-118472, 478-118473, 478-118475, 478-118476,
478-118477, 478-118481, 478-118482, , 478-110227, 478-110228, 478-110390,
478-118731, 478-118896, 478-118930, 478-119528, 478-119529, 478-121488,
478-121526, 478-121527, 478-121530, 478-121531, 478-121541, 478-121930,
478-121931, 478-121932, 478-137038, 478-137073, 478-137126, 478-137134,
478-137185, 478-137197, 478-137198, 478-137199, 478-137200, 478-137201,
478-137202, 478-137203, 478-137204, 478-137205, 478-137206, 478-137207,
478-137208, 478-137211, 478-137212, 478-137213, 478-137214, 478-137215,
478-137216, 478-137217, 478-137218, 478-137219, 478-137220, 478-137221,
478-137225, and 478-137226
RECALLING
FIRM/MANUFACTURER Spacelabs Healthcare, Inc., Issaquah, WA,
REASON Telemetry Modules are failing to alarm for low
heart rate and asystole.
VOLUME OF PRODUCT IN
COMMERCE 37,590
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Kendall
Calf Garment - Reprocessed Sterile device used to cover calf
while conducting sterile procedures.
Catalog No. 5329,
b) Zimmer, 34" Tourniquet Cuff Single
Port Single Bladder Luer Lock Connector Brown Trim, Latex
Free - Reprocessed Sterile device -- Pneumatic tourniquet.
Cataloge No 60-7075-006,
c)
Neonatal/Adult 02 Transducer, (Nellcor), Latex Free. - Reprocessed Sterile
device – Pulse Oximeter. Catalog No. MAX-N,
d) Adult 02 Transducer (Nellcor) - Reprocessed Sterile device
-- Pulse Oximeter. Catalog No. MAX-A,
e) Hill-Rom Foot Garment - Reprocessed Sterile device --
Compressible limb sleeve. Catalog No. P3808,
f) Huntleigh Healthcare, Calf Garment - Regular. -- Reprocessed
Sterile device – Compressible limb sleeve. Catalog No
DVT-10, ;
g) Mitek 3.5 mm Side Effect Electrode - -
Reprocessed Sterile device -- Orthopedic Arthroscope.
Catalog No 225301,
h) Arthrocare 3.6 mm Right Angle -
Reprocessed Sterile device -- Orthopedic Arthroscope.
Catalog No A1336-01, i) Turbovac Suction Wand -
Reprocessed Sterile device -- Orthopedic Arthroscope.
Catalog No AS1335-01,
j) Mitek Angled Side Effect
Electrode - Reprocessed Sterile device -- Orthopedic Arthroscope. Catalog No 225302,
k) Huntleigh Healthcare
Thigh Garment. - Reprocessed Sterile device -- Compressible limb sleeve. Catalog No DVT-30,
l) VasoPress Foot Garment. - Reprocessed Sterile device --
Compressible limb sleeve. Catalog VP 520,
m)Tourniquet Cuff Single Port Single Bladder - Reprocessed
Sterile device -- Pneumatic tourniquet. Catalog No
60-7075-003,
n) Inlet Medical Suture Passer -
Reprocessed Sterile device -- Endoscope and accessories.
Catalog No CTI-512N,
o) Biomet Stablecut Saw Blade -
Reprocessed Sterile device -- Powered Saw and
Accessories. Catalog No 506090,
p) Kendall Thigh
Garment - Reprocessed Sterile device -- Compressible limb sleeve. Catalog No 9530,
q) Stryker
Oscillating & Sagittal Blade - Reprocessed Sterile device -- Powered Saw and Accessories. Catalog No 2296-3-105,
r) Color Cuff II, Double Port Single Bladder - Reprocessed
Sterile device -- Pneumatic tourniquet. Catalog No
DT-7034-02-QC,
s) Zimmer Tourniquet Cuff - Reprocessed
Sterile device -- Pneumatic tourniquet. Catalogue No 60-7070-106,
t) Turbovac Suction Wand - Reprocessed Sterile device --
Orthopedic Arthroscope. Catalog No AS1337-01,
u) Mitek Angled Side Effect Electrode - Reprocessed Sterile
device -- Orthopedic Arthroscope. Catalog No 225304,
v) Stryker Oscillating & Sagittal Blade -
Reprocessed Sterile device -- Powered Saw and
Accessories. Catalog No 2296-3-114,
w) Infant 02
Transducer (Nellcor) - Reprocessed Sterile device -- Pulse Oximeter. Catalog No I-20,
CODE
a) Lot # 135736;
b) Lot #
115010;
c) Lot # 118141, 139207, and 135902;
d) Lot # 118668, 140345,
144466, 148710, 149790, and 149925;
e) Lot # 130849;
f) Lot # 135657,
135889, 136197, and 136402;
g) Lot # 135978;
h) Lot # 135982;
i) Lot #
135992;
j) Lot #136025;
k) Lot # 136178;
l) Lot # 136357;
m) Lot # 136548;
n) Lot #137656;
o) Lot
#145046;
p) Lot #147056;
q) Lot #152838;
r)
Lot #135905;
s) Lot #114986;
t) Lot #136023;
u) Lot
#136027;
v) Lot #152840;
w) Lot #135254
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ascent Healthcare Solutions, Inc.,
Lakeland, FL,
Manufacturer: Venice
International, Orlando, FL.
REASON Sterility Compromised -- Ascent
Healthcare Solutions cannot validate the sterilization process for a variety
products.
VOLUME OF PRODUCT IN COMMERCE 8,306
devices
DISTRIBUTION Nationwide
PRODUCT
GE Healthcare Proteus XR/a Eclipse Collimator model # 2379827,
CODE
Units: 42948HL0, 42949HL8,
43054HL6, 43055HL3, 43056HL1, 43057HL9, 43132HL0, 43133HL8, 43134HL6, 43135HL3,
43201HL3, 43202HL1, 43203HL9, 44605HL4, 44606HL2, 44607HL0, 44608HL8, 44609HL6,
44610HL4, 44681HL5, 45046HL0, 45047HL8, 45048HL6, 45128HL6, 45129HL4, 45130HL2,
45131HL0, 48119HL2, 48120HL0, 48121HL8, 48122HL6, 48123HL4, 48124HL2, 48125HL9,
48126HL7, 48127HL5, 48128HL3, 48164HL8, 48181HL2, 48274HL5, 48276HL0, 48277HL8,
48278HL6, 48680HL3, 48682HL9, 48683HL7, 48684HL5, 48685HL2, 48686HL0, 48687HL8,
48688HL6, 48689HL4, 48876HL7, 48877HL5, 48878HL3, 48995HL3, 48997HL1, 48998HL9,
49000HL3, 49208HL2, 49209HL0, 49210HL8, 49211HL6, 49391HL6, 49392HL4, 49393HL2,
49395HL7, 49494HL8, 49496HL3, 49497HL1, 49498HL9, 49499HL7, 49500HL2, 49501HL0,
49502HL8, 49503HL6, 49681HL0, 49682HL8, 49683HL6, 49684HL4, 49685HL1, 49686HL9,
49687HL7, 49688HL5, 49850HL1, 49851HL9, 49852HL7, 49853HL5, 49855HL0, 49856HL8,
49857HL6, 50027HL2, 50028HL0, 50029HL8, 50030HL6, 50031HL4, 50177HL5, 50178HL3,
50179HL1, 50180HL9, 50321HL9, 50322HL7, 50323HL5, 50324HL3, 50444HL9, 50445HL6,
50446HL4, 50447HL2, 50448HL0, 50449HL8, 50450HL6, 50451HL4, 50452HL2, 50453HL0,
50790HL5, 50791HL3, 50792HL1, 50793HL9, 50794HL9, 50795HL4, 50797HL0, 50798HL8,
50801HL0, 51143HL6, 51144HL4, 51145HL1, 51147HL7, 51486HL9, 51487HL7, 51488HL5,
52014HL8, and 70RD05001
RECALLING FIRM/MANUFACTURER GE
Healthcare, Waukesha, WI,
REASON The actual average illuminance
for the collimators are approximately 140-lux. This does not meet the 160-lux
requirement. GE will be correcting the units by replacing all
collimators.
VOLUME OF PRODUCT IN COMMERCE 132
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
GE Datex-Ohmeda Engstrom Carestation. The Carestation consists of
three main components: a display, a ventilator unit, and an optional module bay.
The display allows the user to interface with the system and control settings.
The ventilator unit controls electrical power, nebulization, and pneumatic gas
flow to and from the patient. The module bay allows the integration of various
patient monitoring modules with the ventilator. This issue affects all of the
Engström Carestations shipped between 12/4/2006 and 9/4/2007, encompassed by
serial numbers CBCK00464 through CBCL01134,
CODE
Serial Number CBCL01134 CBCL01133
CBCL01128 CBCL01089 CBCL01087 CBCL01084 CBCL01075 CBCL01072 CBCL01070 CBCL01068
CBCL01067 CBCL01051 CBCL01050 CBCL01022 CBCL01021- CBCL01019 CBCL01018 CBCL01015
CBCL01012 CBCL01011 CBCL01010 CBCL01009 CBCL01008 CBCL01007 CBCL01000 CBCL00998
CBCL00997 CBCL00996 CBCL00995 CBCL00994 CBCL00993 CBCL00985 CBCL00984 CBCL00983
CBCL00978 CBCL00975 CBCL00974 CBCL00973 CBCL00972 CBCL00971 CBCL00968 CBCL00967
CBCL00966 CBCL00965 CBCL00964 CBCL00963 CBCL00962 CBCL00959 CBCL00958 CBCL00957
CBCL00956 CBCL00955 CBCL00954 CBCL00953 CBCL00952 CBCL00951 CBCL00950 CBCL00949
CBCL00948 CBCL00947 CBCL00946 CBCL00945 CBCL00944 CBCL00943 CBCL00942 CBCL00941
CBCL00940 CBCL00939 CBCL00938 CBCL00937 CBCL00936 CBCL00935 CBCL00934 CBCL00933
CBCL00932 CBCL00931 CBCL00930 CBCL00929 CBCL00928 CBCL00927 CBCL00926 CBCL00925
CBCL00924 CBCL00923 CBCL00922 CBCL00916 CBCL00915 CBCL00914 CBCL00913 CBCL00912
CBCL00911 CBCL00910 CBCL00909 CBCL00908 CBCL00907 CBCL00906 CBCL00905 CBCL00904
CBCL00903 CBCL00902 CBCL00901 CBCL00900 CBCL00899 CBCL00898 CBCL00897 CBCL00896
CBCL00895 CBCL00894 CBCL00893 CBCL00892 CBCL00891 CBCL00890 CBCL00889 CBCL00888
CBCL00887 CBCL00886 CBCL00885 CBCL00884 CBCL00883 CBCL00882 CBCL00881 CBCL00880
CBCL00879 CBCL00878 CBCL00877 CBCL00876 CBCL00875 CBCL00874 CBCL00873 CBCL00872
CBCL00871 CBCL00870 CBCL00869 CBCL00868 CBCL00867 CBCL00866 CBCL00865 CBCL00864
CBCL00863 CBCL00862 CBCL00861 CBCL00860 CBCL00859 CBCL00858 CBCL00857 CBCL00856
CBCL00855 CBCL00854 CBCL00853 CBCL00852 CBCL00851 CBCL00850 CBCL00849 CBCL00848
CBCL00847 CBCL00846 CBCL00845 CBCL00844 CBCL00843 CBCL00841 CBCL00840 CBCL00839
CBCL00837 CBCL00836 CBCL00835 CBCL00833 CBCL00832 CBCL00831 CBCL00830 CBCL00829
CBCL00828 CBCL00827 CBCL00826 CBCL00825 CBCL00824 CBCL00823 CBCL00821 CBCL00820
CBCL00818 CBCL00817 CBCL00816 CBCL00815 CBCL00814 CBCL00813 CBCL00812 CBCL00811
CBCL00810 CBCL00809 CBCL00808 CBCL00807 CBCL00806 CBCL00805 CBCL00804 CBCL00803
CBCL00802 CBCL00801 CBCL00800 CBCL00799 CBCL00798 CBCL00797 CBCL00796 CBCL00795
CBCL00794 CBCL00793 CBCL00792 CBCL00791 CBCL00790 CBCL00789 CBCL00788 CBCL00787
CBCL00786 CBCL00785 CBCL00784 CBCL00783 CBCL00782 CBCL00781 CBCL00780 CBCL00779
CBCL00778 CBCL00777 CBCL00776 CBCL00775 CBCL00774 CBCL00773 CBCL00772 CBCL00771
CBCL00770 CBCL00769 CBCL00768 CBCL00767 CBCL00766 CBCL00765 CBCL00764 CBCL00759
CBCL00758 CBCL00757 CBCL00756 CBCL00755 CBCL00754 CBCL00753 CBCL00752 CBCL00751
CBCL00750 CBCL00749 CBCL00748 CBCL00747 CBCL00746 CBCL00745 CBCL00744 CBCL00743
CBCL00742 CBCL00741 CBCL00740 CBCL00739 CBCL00738 CBCL00737 CBCL00736 CBCL00735
CBCL00734 CBCL00733 CBCL00732 CBCL00731 CBCL00730 CBCL00729 CBCL00728 CBCL00727
CBCL00726 CBCL00725 CBCL00724 CBCL00723 CBCL00722 CBCL00721 CBCL00720 CBCL00719
CBCL00718 CBCL00717 CBCL00716 CBCL00715 CBCL00714 CBCL00713 CBCL00712 CBCL00711
CBCL00710 CBCL00709 CBCL00708 CBCL00707 CBCL00706 CBCL00705 CBCL00704 CBCL00703
CBCL00702 CBCL00701 CBCL00700 CBCL00699 CBCL00698 CBCL00697 CBCL00696 CBCL00695
CBCL00694 CBCL00693 CBCL00692 CBCL00691 CBCL00690 CBCL00689 CBCL00688 CBCL00687
CBCL00684 CBCL00683 CBCL00682 CBCL00681 CBCL00680 CBCL00679 CBCL00678 CBCL00677
CBCL00676 CBCL00675 CBCL00674 CBCL00673 CBCL00672 CBCL00671 CBCL00670 CBCL00669
CBCL00668 CBCL00667 CBCL00666 CBCL00665 CBCL00664 CBCL00663 CBCL00662 CBCL00661
CBCL00660 CBCL00659 CBCL00658 CBCL00657 CBCL00656 CBCL00655 CBCL00654 CBCL00653
CBCL00652 CBCL00651 CBCL00650 CBCL00649 CBCL00648 CBCL00647 CBCL00646 CBCL00645
CBCL00644 CBCL00643 CBCL00642 CBCL00641 CBCL00640 CBCL00639 CBCL00638 CBCL00637
CBCL00636 CBCL00635 CBCL00634 CBCL00633 CBCL00632 CBCL00631* CBCL00630*
CBCL00629* CBCL00628* CBCL00627* CBCL00626* CBCL00625* CBCL00624* CBCL00623
CBCL00622 CBCL00621 CBCL00620 CBCL00619 CBCL00618 CBCL00617 CBCL00616 CBCL00615
CBCL00614 CBCL00613 CBCL00612 CBCL00611 CBCL00610 CBCL00609 CBCL00608 CBCL00607
CBCL00606 CBCL00605 CBCL00604 CBCL00603 CBCL00602 CBCL00600 CBCL00599 CBCL00598
CBCL00597 CBCL00596 CBCL00595 CBCL00594 CBCL00593 CBCL00592 CBCL00591 CBCL00590
CBCL00589 CBCL00588 CBCL00587 CBCL00586 CBCL00585 CBCL00584 CBCL00583 CBCL00582
CBCL00581 CBCL00580 CBCL00579 CBCL00578 CBCL00577 CBCL00576 CBCL00575 CBCL00574
CBCL00573 CBCL00572 CBCL00571 CBCL00570 CBCL00569 CBCL00568 CBCL00567 CBCL00566
CBCL00565 CBCL00564 CBCL00563 CBCL00562 CBCL00561 CBCL00560 CBCL00559 CBCL00558
CBCL00557 CBCL00556 CBCL00555 CBCL00554 CBCL00553 CBCL00552 CBCL00551 CBCL00550
CBCL00549 CBCL00548 CBCL00547 CBCL00546 CBCL00545 CBCL00544 CBCL00543 CBCL00542
CBCL00541 CBCL00540 CBCL00539 CBCL00538 CBCL00537 CBCL00536 CBCL00535 CBCL00534
CBCL00533 CBCL00532 CBCL00531 CBCL00530 CBCL00529 CBCL00528 CBCL00527 CBCL00526
CBCL00525 CBCL00524 CBCL00523 CBCL00522 CBCL00521 CBCL00520 CBCL00519 CBCL00518
CBCL00517 CBCL00516 CBCL00515 CBCL00514 CBCL00513 CBCL00511 CBCL00510 CBCL00509
CBCL00508 CBCL00507 CBCL00506 CBCL00505 CBCL00503 CBCL00501 CBCL00500 CBCL00499
CBCL00498 CBCL00497 CBCL00496 CBCL00495 CBCL00494 CBCL00493 CBCL00492 CBCL00491
CBCL00490 CBCL00489 CBCL00488 CBCL00487 CBCL00486 CBCL00485 CBCL00484 CBCL00483
CBCL00482 CBCL00481 CBCL00480 CBCL00479 CBCL00478 CBCL00477 CBCL00476 CBCL00475
CBCL00474 CBCL00473 CBCL00472 CBCL00471 CBCL00470 CBCL00469 CBCL00468 CBCL00467
CBCL00466 CBCL00465 CBCL00464 CBCL00463 CBCL00462 CBCL00461 CBCL00460 CBCL00459
CBCL00458 CBCL00457 CBCL00456 CBCL00455 CBCL00454 CBCL00453 CBCL00452 CBCL00451
CBCL00450 CBCL00449 CBCL00448 CBCL00447 CBCL00446 CBCL00445 CBCL00444 CBCL00443
CBCL00442 CBCL00441 CBCL00440 CBCL00439 CBCL00438 CBCL00437 CBCL00436 CBCL00435
CBCL00434 CBCL00433 CBCL00432 CBCL00431 CBCL00430 CBCL00429 CBCL00428 CBCL00427
CBCL00426 CBCL00425 CBCL00424 CBCL00423 CBCL00422 CBCL00421 CBCL00420 CBCL00419
CBCL00418 CBCL00417 CBCL00416 CBCL00415 CBCL00414 CBCL00413 CBCL00412 CBCL00411
CBCL00410 CBCL00409 CBCL00408 CBCL00407 CBCL00406 CBCL00405 CBCL00404 CBCL00403
CBCL00402 CBCL00401 CBCL00400 CBCL00399 CBCL00398 CBCL00397 CBCL00396 CBCL00395
CBCL00394 CBCL00393 CBCL00392 CBCL00391 CBCL00390 CBCL00389- CBCL00388
CBCL00387- CBCL00386- CBCL00385 CBCL00384 CBCL00383 CBCL00382 CBCL00381
CBCL00380 CBCL00379 CBCL00378 CBCL00377 CBCL00376 CBCL00375 CBCL00374 CBCL00373
CBCL00372 CBCL00371 CBCL00370 CBCL00369 CBCL00368 CBCL00367 CBCL00366 CBCL00365
CBCL00364 CBCL00363 CBCL00362 CBCL00361 CBCL00360 CBCL00359 CBCL00358 CBCL00357
CBCL00356 CBCL00355 CBCL00354 CBCL00353 CBCL00352 CBCL00351 CBCL00350 CBCL00349
CBCL00348 CBCL00347 CBCL00346 CBCL00345 CBCL00344 CBCL00343 CBCL00342 CBCL00341
CBCL00340 CBCL00339 CBCL00338 CBCL00337 CBCL00336 CBCL00335 CBCL00334 CBCL00333
CBCL00332 CBCL00331 CBCL00330 CBCL00329 CBCL00328 CBCL00327 CBCL00326 CBCL00325
CBCL00324 CBCL00323 CBCL00322 CBCL00321 CBCL00320 CBCL00319 CBCL00318 CBCL00317
CBCL00316 CBCL00315 CBCL00314 CBCL00313 CBCL00312 CBCL00311 CBCL00310 CBCL00309
CBCL00308 CBCL00307 CBCL00306 CBCL00305 CBCL00304 CBCL00303 CBCL00302 CBCL00301
CBCL00300 CBCL00299 CBCL00298 CBCL00297 CBCL00296 CBCL00295 CBCL00294 CBCL00293
CBCL00292 CBCL00291 CBCL00290 CBCL00289 CBCL00288 CBCL00287 CBCL00286 CBCL00285
CBCL00284 CBCL00283 CBCL00282 CBCL00281 CBCL00280 CBCL00279 CBCL00278 CBCL00277
CBCL00276 CBCL00275 CBCL00274 CBCL00273 CBCL00272 CBCL00271 CBCL00270 CBCL00269
CBCL00268 CBCL00267 CBCL00266 CBCL00265 CBCL00264 CBCL00263 CBCL00262 CBCL00261
CBCL00260 CBCL00259 CBCL00258 CBCL00257 CBCL00256 CBCL00255 CBCL00253 CBCL00252
CBCL00251 CBCL00250 CBCL00249 CBCL00248 CBCL00247 CBCL00246 CBCL00245 CBCL00244
CBCL00243 CBCL00242 CBCL00241 CBCL00240 CBCL00239 CBCL00238 CBCL00237 CBCL00236
CBCL00235 CBCL00234 CBCL00233 CBCL00232 CBCL00231 CBCL00230 CBCL00229 CBCL00228
CBCL00227 CBCL00226 CBCL00225 CBCL00224 CBCL00223 CBCL00222 CBCL00221 CBCL00220
CBCL00219 CBCL00218 CBCL00217 CBCL00216 CBCL00215 CBCL00214 CBCL00213 CBCL00212
CBCL00211 CBCL00210 CBCL00209 CBCL00208 CBCL00207 CBCL00206 CBCL00205 CBCL00204
CBCL00203 CBCL00202 CBCL00201 CBCL00200 CBCL00199 CBCL00198 CBCL00197 CBCL00196
CBCL00195 CBCL00194 CBCL00193 CBCL00192 CBCL00191 CBCL00190 CBCL00189 CBCL00188
CBCL00187 CBCL00186 CBCL00185 CBCL00184 CBCL00183 CBCL00182 CBCL00181 CBCL00180
CBCL00179 CBCL00178 CBCL00177 CBCL00175 CBCL00174 CBCL00172 CBCL00171 CBCL00170
CBCL00169 CBCL00168 CBCL00167 CBCL00166 CBCL00164 CBCL00163 CBCL00162 CBCL00161
CBCL00160 CBCL00159 CBCL00158 CBCL00157 CBCL00156 CBCL00155 CBCL00154 CBCL00153
CBCL00152 CBCL00151 CBCL00150 CBCL00149 CBCL00148 CBCL00147 CBCL00146 CBCL00145
CBCL00144 CBCL00143 CBCL00142 CBCL00141 CBCL00140 CBCL00139 CBCL00138 CBCL00137
CBCL00136 CBCL00135 CBCL00133 CBCL00132 CBCL00131 CBCL00130 CBCL00129 CBCL00128
CBCL00127 CBCL00126 CBCL00125 CBCL00124 CBCL00123 CBCL00122 CBCL00121 CBCL00120
CBCL00119 CBCL00118 CBCL00117 CBCL00116 CBCL00115 CBCL00114 CBCL00113 CBCL00112
CBCL00111 CBCL00110 CBCL00108 CBCL00107 CBCL00106 CBCL00105 CBCL00104 CBCL00103
CBCL00102 CBCL00101 CBCL00100 CBCK00883 CBCK00882 CBCK00881 CBCK00880 CBCK00879
CBCK00878 CBCK00877 CBCK00876 CBCK00875 CBCK00874 CBCK00873 CBCK00872 CBCK00871
CBCK00870 CBCK00869 CBCK00868 CBCK00867 CBCK00866 CBCK00865 CBCK00864 CBCK00863
CBCK00862 CBCK00861 CBCK00860 CBCK00859 CBCK00858 CBCK00857 CBCK00856 CBCK00855
CBCK00854 CBCK00853 CBCK00852 CBCK00851 CBCK00850 CBCK00849 CBCK00848 CBCK00847
CBCK00846 CBCK00845 CBCK00844 CBCK00843 CBCK00842 CBCK00841 CBCK00840 CBCK00839
CBCK00838 CBCK00837 CBCK00836 CBCK00835 CBCK00834 CBCK00833 CBCK00832 CBCK00831
CBCK00830 CBCK00829 CBCK00828 CBCK00827 CBCK00826 CBCK00825 CBCK00824 CBCK00823
CBCK00822 CBCK00821 CBCK00820 CBCK00819 CBCK00818 CBCK00817 CBCK00816 CBCK00815
CBCK00814 CBCK00813 CBCK00812 CBCK00811 CBCK00810 CBCK00809 CBCK00808 CBCK00807
CBCK00806 CBCK00805 CBCK00803 CBCK00802 CBCK00801 CBCK00800 CBCK00799 CBCK00798
CBCK00797 CBCK00796 CBCK00795 CBCK00794 CBCK00793 CBCK00792 CBCK00791 CBCK00790
CBCK00789 CBCK00788 CBCK00787 CBCK00786 CBCK00785 CBCK00784 CBCK00783 CBCK00782
CBCK00781 CBCK00780 CBCK00779 CBCK00778 CBCK00777 CBCK00776 CBCK00775 CBCK00774
CBCK00773 CBCK00772 CBCK00771 CBCK00770 CBCK00769 CBCK00768 CBCK00767 CBCK00766
CBCK00765 CBCK00764 CBCK00763 CBCK00762 CBCK00761 CBCK00760 CBCK00759 CBCK00758
CBCK00757 CBCK00756 CBCK00755 CBCK00754 CBCK00753 CBCK00752 CBCK00751 CBCK00750
CBCK00749 CBCK00745 CBCK00744 CBCK00743 CBCK00742 CBCK00741 CBCK00740 CBCK00739
CBCK00738* CBCK00737 CBCK00736 CBCK00735 CBCK00734 CBCK00733 CBCK00732 CBCK00730
CBCK00729* CBCK00728 CBCK00727 CBCK00725 CBCK00724 CBCK00723 CBCK00722 CBCK00721
CBCK00720 CBCK00719 CBCK00718 CBCK00717 CBCK00716 CBCK00715 CBCK00714 CBCK00713
CBCK00712 CBCK00711 CBCK00710 CBCK00709 CBCK00708 CBCK00707 CBCK00706 CBCK00705
CBCK00704 CBCK00703 CBCK00702 CBCK00701 CBCK00700 CBCK00699 CBCK00698 CBCK00697
CBCK00696 CBCK00695 CBCK00694 CBCK00693 CBCK00692 CBCK00691 CBCK00690 CBCK00689
CBCK00688 CBCK00687 CBCK00686 CBCK00685 CBCK00684 CBCK00683 CBCK00682 CBCK00681
CBCK00680 CBCK00679 CBCK00678 CBCK00677 CBCK00676 CBCK00675 CBCK00674 CBCK00673
CBCK00672 CBCK00671 CBCK00670 CBCK00669 CBCK00668 CBCK00666 CBCK00665 CBCK00664
CBCK00663 CBCK00662 CBCK00661 CBCK00660 CBCK00659 CBCK00658 CBCK00657 CBCK00656
CBCK00655 CBCK00654 CBCK00653 CBCK00652 CBCK00651 CBCK00650 CBCK00649 CBCK00648
CBCK00647 CBCK00642 CBCK00626 CBCK00614 CBCK00613 CBCK00612 CBCK00611 CBCK00560
CBCK00559 CBCK00558 CBCK00557 CBCK00556 CBCK00555 CBCK00554 CBCK00552 CBCK00551
CBCK00550 CBCK00469 and CBCK00464
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI,
Manufacturer: Datex –
Ohmeda, Inc., Madison, WI.
REASON There is a
correction associated with Engstrom Carestation with an integrated Aerogen
Professional Nebulizer System. There is an issue relating to the removal of the
nebulizer cable from nebulizer connection port, which, when done while the
nebulizer is active, may result in the discontinuance of mechanical ventilation.
VOLUME OF PRODUCT IN COMMERCE 1,130
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Gambro Cartridge Blood Set, 003410-510, is intended for single
use in a hemodialysis treatment using the Phoenix and
Centry system 3 Dialysis Delivery Systems,
b) Gambro Cartridge Blood Set, 0141080XXXC, is intended for single use
in a hemodialysis treatment using the Phoenix and Centry
system 3 Dialysis Delivery Systems,
CODE
a) Serial numbers: 04P158215 and below,
03P158XXX (all lots);
b) Serial numbers: 0XP15XXXX (all
lots)
RECALLING FIRM/MANUFACTURER
Recalling Firm: Gambro
Renal Products, Inc., Lakewood, CO,
Manufacturer: Gambro Renal Products
S.A. de C.V., Tijuana,
B.C. Mexico.
REASON Dialysis tubing sets may have occlusions
restricting blood flow.
VOLUME OF PRODUCT IN
COMMERCE 1,500,000
sets
DISTRIBUTION Nationwide
PRODUCT Hawkins
III Breast Localization Needle. Product # 243075. The product is used in the
marking of non-palpable lesions,
CODE Lot # 80281L5V
RECALLING
FIRM/MANUFACTURER Medical Device Technologies, Inc., Gainesville, FL
REASON
The sterility of the product cannot be
guaranteed.
VOLUME OF PRODUCT IN COMMERCE 490
units
DISTRIBUTION Nationwide and
Mexico
PRODUCT GE
Healthcare Definium 8000 Digital Radiographic System, model number 5135678. The
intended use of this product is to generate tomographic images of human anatomy,
CODE
Serial numbers: 0000000002772E,
00000001191M36, 00000001561M30, 00000001895M32, 00000002041M32, 00000002047M39,
00000002051M31, 00000002052M39, 00000002065M31, 00000002364M38, 00000002439M38,
00000002441M34, 00000002650M30, 00000002767EN2, 00000002771M34, 00000002965M32,
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RECALLING
FIRM/MANUFACTURER GE Healthcare, Waukesha, WI,
REASON
Not properly labeling the manual switch
for disabling positive beam limitation (PBL) located on the overhead tube
support user interface as required.
VOLUME OF PRODUCT IN
COMMERCE 668 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) GE OEC 9800 Fluoroscopic X-Ray System. The intended use of this
device is to perform mobile fluoroscopic examination of
human anatomy,
b) GE OEC 9900 Elite Fluoroscopic X-Ray
System. The intended use of this device is to perform
mobile fluoroscopic examination of human anatomy,
CODE
a) Serial Numbers: 82-2965, 82-3366,
82-3403, 82-3563, 82-3570, 82-3614, 82-3634, 82-3815, 82-3839, 82-3851, 82-3882,
82-3884, 82-3887, 82-3888, 82-3890, 82-3894, 82-3895, 82-3896, 82-3898, 82-3899,
82-3901, 82-3903, 82-3904, 82-3910, 82-3911, 82-3912, 82-3913, 82-3914, 82-3915,
82-3917, 82-3919, 82-3920, 82-3921, 82-3922, 82-3923, 82-3925, 82-3928, 82-3929,
82-3930, 82-3931, 82-3933, 82-3934, 82-3935, 82-3936, 82-3937, 82-3938, 82-3939,
82-3941, 82-3942, 82-3943, 82-7154-CMH, 82-7189-MH, 82-7190-MH, 82-7191-MH,
82-7197-MH, 82-7200, 82-7206, 89-3211, 89-3355, 89-3420, 89-3461, 89-3479,
89-3483, 89-3488, 89-3490, 89-3494, 89-3495, 89-3499, 89-3501, 89-3504, 89-3508,
89-3509, 89-3511, 89-3512, 89-3513, 89-3514, 89-3515, 89-3519, 89-3520, 89-3522,
89-3524, 89-3527, 89-3529, 89-3530, 89-3533, 89-3537, 89-3538, 89-3539, 89-3543,
89-3544, 89-3545, 89-3546, 89-3547, 89-89-3549, 89-3551, 89-3552, 89-3553,
89-3554, 89-3555, 89-3556, 89-3557, 89-3558, 89-3559, 89-3560, 89-3561, 89-3562,
89-3563, 89-3564, 89-3565, 89-3567, 89-3568, 89-3569, 89-3570, 89-3571, 89-3572,
89-3573, 89-3574, 89-3578, 89-3579, 8S-1474-C, 8S-2329, 8S-2462, 8S-2532,
8S-2985, 8S-3111, 8S-3112, 8S-3179, 8S-3183, 8S-3197, 8S-3205, 8S-3207,
8S-3211-CH, 8S-3216, 8S-3222, 8S-3231, 8S-3233, 8S-3243, 8S-3245, 8S-3246,
8S-3247, 8S-3248, 8S-3249, 8S-3253, 8S-3254, 8S-3255, 8S-3256, 8S-3257, 8S-3258,
8S-3259, 8S-3260, 8S-3261, 8S-3262, 8S-3263, 8S-3264, 8S-3265, 8S-3266, 8S-3267,
8S-3268, 8S-3269-H, 8S-3270-H, 8S-3271-H, 8S-3272-H, 8S-3273-CH, 8S-3274-CH,
8S-3275, 8S-3276, 8S-3278, 8S-3279, 8S-3280, 8S-3281, 8S-3282, 8S-3283, 8S-3285,
8S-3286, 8S-3287, 8S-3288-H, 8S-3289-H, 8S-3291, 8S-3292, 8S-3296, 8S-3299,
8S-3301-H, 8S-3302, 8S-3305, 8S-3306, 8S-3307, 8S-3308, 8S-3309, 8S-3310-H,
8S-3311, 8S-3315, 8S-7094-CMH, 8S-7228-CMH, 8S-7229-CMH, 8S-7230-CMH,
8S-7231-MH, 8S-7232-MH, and 8S-7233-MH;
b) Serial Numbers: E2-0001,
E2-0015, E2-0026, E2-0028, E2-0084, E2-0108, E2-0111, E2-0117, E2-0120, E2-0122,
E2-0130, E2-0143, E2-0148, E2-0151, E2-0152, E2-0153, E2-0154, E2-0155, E2-0156,
E2-0157, E2-0158, E2-0159, E2-0160, E2-0161, E2-0162, E2-0163, E2-0164, E2-0165,
E2-0167, E2-0168, E2-0169, E2-0171, E2-0172, E2-0173, E2-0174, E2-0175, E2-0176,
E2-0177, E2-0178, E2-0179, E2-0180, E2-0181, E2-0182, E2-0183, E2-0184, E2-0185,
E2-0186, E2-0187, E2-0188, E2-0189, E2-0190, E2-0191, E2-0192, E2-0193, E2-0194,
E2-0195, E2-0196, E2-0197, E2-0198, E2-0199, E2-0200, E2-0201, E2-0202, E2-0203,
E2-0204, E2-0205, E2-0206, E2-0207, E2-0208, E2-0209, E2-0210, E2-0211, E2-0212,
E2-0213, E2-0215, E2-0217, E2-0222, E2-0224, E2-0225, E2-0230, E2-0231, E2-0232,
E2-0233, E2-0234, E2-0235-C, E2-0237, E2-0238, E2-0239, E2-0240, E2-0241,
E2-0242, E2-0243, E2-0244, E2-0245, E2-0246, E2-0247, E2-0248, E2-0250, E2-0251,
E2-0252, E2-0253, E2-0254, E2-0255, E2-0256, E2-0257, E2-0258, E2-0259, E2-0260,
E2-0261, E2-0262, E2-0263, E2-0264, E2-0265, E2-0266, E2-0267, E2-0268, E2-0269,
E2-0270, E2-0271, E2-0272, E2-0273, E2-0274, E2-0275, E2-7014-MH, E2-7020-MH,
E2-7048-MH, E2-7050-MH, E2-7051-MH, E2-7057-MH, E2-7058-MH, E2-7059-MH,
E2-7060-MH, E2-7061-MH, E2-7062-MH, E2-7063-MH, E2-7064-MH, E2-7065-MH,
E2-7066-MH, E2-7067-MH, E2-7068-MH, E2-7069-CMH, E2-7070-MH, E2-7071-MH,
E2-7072-MH, E2-7074-MH, E2-7075-MH, E2-7076-MH, E2-7077-CMH, E2-7078-MH,
E2-7079-MH, E9-0025, E9-0031, E9-0037, E9-0050, E9-0083, E9-0085, E9-0086,
E9-0088, E9-0089-G, E9-0090, E9-0091, E9-0092, E9-0093, E9-0094, E9-0095,
E9-0098, E9-0099, E9-0100, E9-0101, E9-0102, E9-0103, E9-0108, E9-0109, E9-0110,
E9-0111, E9-0112, E9-0113, E9-0114, E9-0115, E9-0116, E9-0118, E9-0119, E9-0120,
E9-0121, E9-0122, E9-0123, E9-0124, E9-0125, E9-0126, E9-0127, E9-0128, E9-0129,
E9-0130, E9-0139, E9-0141, E9-0142, E9-0143, E9-0144, E9-0145, E9-0146, E9-0147,
E9-0148, E9-0149, E9-0150, E9-0151, E9-0152, E9-0153, E9-0155, E9-0157, E9-0158,
E9-0159, E9-0162, E9-0163, E9-0164, E9-0165, E9-0166, E9-0169, E9-0170, E9-0171,
E9-0172, E9-0173, E9-0177, E9-0178, E9-0179, E9-0180, E9-0181, E9-0183, E9-0184,
E9-0185, E9-0188, E9-0249, E9-0253, ES-0005, ES-0006, ES-0007-C, ES-0022-CH,
ES-0029-CH, ES-0056, ES-0069, ES-0071, ES-0072, ES-0078, ES-0084-G, ES-0086-G,
ES-0087, ES-0088, ES-0089, ES-0090, ES-0091-H, ES-0092-CH, ES-0096, ES-0097,
ES-0098, ES-0099-CH, ES-0101-CH, ES-0102-CH, ES-0103, ES-0104, ES-0105, ES-0106,
ES-0107, ES-0108, ES-0109, ES-0110, ES-0111, ES-0112, ES-0113, ES-0114, ES-0115,
ES-0116, ES-0117, ES-0118, ES-0119, ES-0120, ES-0121, ES-0122, ES-0123, ES-0124,
ES-0125, ES-0126, ES-0127, ES-0128, ES-0129, ES-0130, ES-0131-H, ES-0132,
ES-0133, ES-0134, ES-0135, ES-0136, ES-0138, ES-0139, ES-0140, ES-0141, ES-0142,
ES-0147, ES-0155-H, ES-0156, ES-0158, ES-0159, ES-0160, ES-0163-G, ES-0169-CH,
ES-0170, ES-0171, ES-0172, ES-0176, ES-0178, ES-0180, ES-0181, ES-0182,
ES-0184-CH, ES-0185-H, ES-0186-H, ES-0187-H, ES-0190-CH, ES-0191-H, ES-0192-H,
ES-7010-CMH, ES-7015-MH, ES-7018-MH, ES-7021-MH, ES-7028-CMH, ES-7029-MH,
ES-7030-CMH, ES-7031-CMH, ES-7033-CMH, ES-7034-CMH, ES-7035-CMH, ES-7036-CMH,
ES-7037-CMH, and ES-7039-MH
RECALLING
FIRM/MANUFACTURER OEC Medical Systems, Inc., Salt Lake City, UT,
REASON
Beam limitation may be non-compliant on
some X-ray units.
VOLUME OF PRODUCT IN COMMERCE 536
units
DISTRIBUTION Nationwide
PRODUCT
a) Model 2000 CMS/ Model 2000 Plus Ambulatory Infusion Pump, Model
Number: 340-1001,
b) Model 4000
Plus Ambulatory Infusion Pump, Model Number: 350-1001,
c) Model 4000 CMS Ambulatory Infusion
Pump, Model Number: 350-1101,
d)
Model 6000 CMS, CMS IOD, or Plus Ambulatory Infusion Pump, Model Number: 360-1101,
e)
PainSmart,
PainSmart IOD Ambulatory Infusion System, Model Number: 360-1301;
CODE Serial
Numbers for all affected units: 100074 to 210458
RECALLING
FIRM/MANUFACTURER Curlin Medical Llc, Huntington Beach, CA,
REASON
Over-delivery/free-flow involving Curlin
ambulatory peristaltic multi-therapy infusion pumps where the pumping chamber
door (platen) had become deformed in a manner that permitted gravity
flow.
VOLUME OF PRODUCT IN COMMERCE 39,366
units
DISTRIBUTION Nationwide, Australia, Croatia,
Germany, Italy, New Zealand, and South
Africa
PRODUCT
1) Margron DTC Hip Replacement System; Margron hip - Femoral
neck Y, sterile; REF 1-746-000. Product is used for
Orthopedic surgery,
2) Margron DTC Hip
Replacement System; Margron hip - Femoral neck Z,
sterile; REF 1-747-000. Product is used for
Orthopedic surgery,
3) Margron
DTC Hip Replacement System; Margron hip - Femoral neck AZ,
sterile; REF 1-750-000. Product is used for
Orthopedic surgery,
4) Margron
DTC Hip Replacement System; Margron hip - Femoral neck A, sterile; REF 1-654-000. Product is used for Orthopedic
surgery,
5) Margron DTC Hip
Replacement System; Margron hip - Femoral neck B, sterile; REF 1-656-000. Product is used for Orthopedic
surgery,
6) Margron DTC Hip
Replacement System; Margron hip - Femoral neck C, sterile; REF 1-658-000. Product is used for Orthopedic surgery,
7) Margron DTC Hip Replacement
System; Margron hip - Femoral neck CB+6, sterile;
REF 1-685-000. Product is used for Orthopedic surgery,
8) Margron DTC Hip Replacement System; Margron
hip - Femoral neck B-A, sterile; REF 1-686-000.
Product is used for Orthopedic surgery,
9) Margron DTC Hip Replacement System; Margron
hip - Femoral neck C-A, sterile; REF 1-687-000.
Product is used for Orthopedic surgery,
10) Margron DTC Hip Replacement System; Margron hip -
Femoral neck C-B, sterile; REF 1-688-000.
Product is used for Orthopedic surgery,
11) Margron DTC Hip Replacement System; Margron hip -
Femoral neck B+4, sterile; REF 1-689-000.
Product is used for Orthopedic surgery,
12) Margron DTC Hip Replacement System; Margron hip -
Femoral neck C+6, sterile; REF 1-690-000.
Product is used for Orthopedic surgery,
13) Margron DTC Hip Replacement System; Margron hip -
Femoral stem Y+0, sterile; REF 1-726-000.
Product is used for Orthopedic surgery,
14) Margron DTC Hip Replacement System; Margron hip -
Femoral stem Z+0, sterile; REF 1-727-000.
Product is used for Orthopedic surgery,
15) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 1+0, sterile; REF
1-647-000. Product is used for Orthopedic surgery,
16) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 2+0, sterile; REF 1-648-000.
Product is used for Orthopedic surgery,
17) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 3+0, sterile; REF 1-649-000.
Product is used for Orthopedic surgery,
18) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 4+0, sterile; REF 1-650-000.
Product is used for Orthopedic surgery,
19) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 5+0, sterile; REF 1-651-000.
Product is used for Orthopedic surgery,
20) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 6+0, sterile; REF 1-652-000.
Product is used for Orthopedic surgery,
21) Margron DTC Hip Replacement System; Margron hip -
Femoral stem Y+1, sterile; REF 1-730-061.
Product is used for Orthopedic surgery,
22) Margron DTC Hip Replacement System; Margron hip -
Femoral stem Y+2, sterile; REF
1-730-062. Product is used for Orthopedic surgery,
23) Margron DTC Hip Replacement System; Margron
hip - Femoral stem Z+1, sterile; REF
1-730-071. Product is used for Orthopedic surgery,
24) Margron DTC Hip Replacement System; Margron hip -
Femoral stem Z+2, sterile; REF 1-730-072.
Product is used for Orthopedic surgery,
25) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 1+1, sterile; REF 2-662-011.
Product is used for Orthopedic surgery,
26) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 1+2, sterile, REF 2-662-012.
Product is used for Orthopedic surgery,
27) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 2+1, sterile; REF 2-662-021.
Product is used for Orthopedic surgery,
28) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 2+2, sterile, REF
2-662-022. Product is used for Orthopedic surgery,
29) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 3+1, sterile; REF 2-662-031.
Product is used for Orthopedic surgery,
30) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 3+2, sterile; REF 2-662-032.
Product is used for Orthopedic surgery,
31) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 4+1, sterile; REF
2-662-041. Product is used for Orthopedic surgery,
32) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 4+2, sterile; REF 2-662-042.
Product is used for Orthopedic surgery,
33) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 5+1, sterile; REF 2-662-051.
Product is used for Orthopedic surgery,
34) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 5+2, sterile; REF 2-662-052.
Product is used for Orthopedic surgery,
35) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 6+1, sterile; REF 2-662-061.
Product is used for Orthopedic surgery,
36) Margron DTC Hip Replacement System; Margron hip -
Femoral stem 6+2, sterile; REF 2-662-062.
Product is used for Orthopedic surgery,
37) Margron DTC Hip Replacement System; Margron hip -
Femoral stem + suture holes Y+3, sterile; REF
1-730-963. Product is used for Orthopedic surgery,
38)
Margron DTC Hip Replacement System; Margron hip - Femoral stem + suture holes Y+4, sterile; REF 1-730-964. Product is
used for Orthopedic surgery,
39) Margron DTC Hip Replacement System; Margron hip -
Femoral stem + suture holes Y+5, sterile; REF
1-730-965. Product is used for Orthopedic surgery,
40) Margron DTC Hip Replacement
System; Margron hip - Femoral stem +
suture holes Z+3, sterile; REF
1-730-973. Product is used for Orthopedic surgery,
41) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes Z+4, sterile; REF 1-730-974. Product is
used for Orthopedic surgery,
42) Margron DTC Hip Replacement System; Margron hip - Femoral
stem + suture holes Z+5, sterile; REF
1-730-975. Product is used for Orthopedic surgery,
43) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 1+3, sterile; REF 2-662-913. Product is
used for Orthopedic surgery,
44) Margron DTC Hip Replacement System; Margron hip - Femoral
stem + suture holes 1+4, sterile; REF
2-662-914. Product is used for Orthopedic surgery,
45) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 1+5, sterile; REF 2-662-915. Product is
used for Orthopedic surgery
46) Margron DTC Hip Replacement System; Margron hip - Femoral
stem + suture holes 2+3, sterile; REF
2-662-923. Product is used for Orthopedic surgery,
47) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 2+4, sterile; REF 2-662-924. Product is
used for Orthopedic surgery,
48) Margron DTC Hip Replacement System; Margron hip - Femoral
stem + suture holes 2+5, sterile, Portland
Orthopaedics Inc., St. Clair, MI; REF 2-662-925. Product is used for Orthopedic surgery,
49) Margron DTC Hip Replacement System; Margron hip -
Femoral stem + suture holes 3+3, sterile,
Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-933.
Product is used for Orthopedic surgery,
50) Margron DTC Hip Replacement System; Margron hip -
Femoral stem + suture holes 3+4, sterile,
Portland Orthopaedics Inc., St. Clair, MI; REF 2-662-934.
Product is used for Orthopedic surgery,
51) Margron DTC Hip Replacement System;
Margron hip - Femoral stem + suture holes
3+5, sterile; REF 2-662-935. Product is used for Orthopedic surgery,
52) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 4+3, sterile; REF 2-662-943.
Product is used for Orthopedic surgery,
53) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 4+4, sterile; REF 2-662-944. Product is
used for Orthopedic surgery,
54) Margron DTC Hip Replacement System; Margron hip - Femoral
stem + suture holes 4+5, sterile; REF
2-662-945. Product is used for Orthopedic surgery,
55) Margron DTC Hip Replacement
System; Margron hip - Femoral stem + suture
holes 5+3, sterile; REF 2-662-953. Product is used for Orthopedic surgery,
56) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 5+4, sterile; REF 2-662-954.
Product is used for Orthopedic surgery,
57) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 5+5, sterile; REF 2-662-955.
Product is used for Orthopedic surgery,
58) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 5+6, sterile; REF 2-662-956. Product is
used for Orthopedic surgery,
59) Margron DTC Hip Replacement System; Margron hip - Femoral
stem + suture holes 6+3, sterile; REF
2-662-963. Product is used for Orthopedic surgery,
60) Margron DTC Hip
Replacement System; Margron hip - Femoral stem + suture holes 6+4, sterile; REF 2-662-964. Product is used
for Orthopedic surgery,
61) Margron DTC Hip Replacement System; Margron hip - Femoral
stem + suture holes 6+5, sterile; REF
2-662-965, 62) Margron DTC Hip Replacement System;
Margron hip - Femoral stem + suture holes
6+6, sterile; REF 2-662-966, 63) Margron DTC Hip
Replacement System; Margron hip extension module AA6, sterile; REF 2-662-201. Product is used for
Orthopedic surgery,
64) Margron DTC Hip Replacement System; Margron hip extension
module AA7, sterile; REF 2-662-202.
Product is used for Orthopedic surgery,
65) Margron DTC Hip
Replacement System; Margron hip extension module BB6, sterile, REF 2-662-203. Product is used
for Orthopedic surgery,
66) Margron DTC Hip Replacement System; Margron hip extension
module BB7, sterile; REF 2-662-204.
Product is used for Orthopedic surgery,
67) Margron DTC Hip
Replacement System; Margron hip extension module CC7, sterile; REF 2-662-205. Product is used
for Orthopedic surgery,
68) Margron DTC Hip Replacement System; Margron hip extension
module YY6, sterile; REF 2-731-005.
Product is used for Orthopedic surgery,
69) Margron DTC Hip
Replacement System; Margron hip extension module YY7, sterile; REF 2-731-006. Product is used
for Orthopedic surgery,
70) Margron DTC Hip Replacement System; Margron hip extension
module ZZ6, sterile; REF 2-731-007.
Product is used for Orthopedic surgery,
71) Margron DTC Hip
Replacement System; Margron hip extension module ZZ7, sterile; REF 2-731-008. Product is used for
Orthopedic surgery,
CODE All lots
RECALLING
FIRM/MANUFACTURER Portland Orthopaedics Pty, Ltd., Saint George
Hospital, Kogarah, Australia,
REASON Australian data indicates the
product is associated with a higher than average rate of hip replacement
revision surgery.
VOLUME OF PRODUCT IN COMMERCE 2,403
units
DISTRIBUTION Nationwide
PRODUCT 6.5 Cancellous Bone Screw 25 mm; Made in USA; Catalog Number:
2030-6525-1 The Omnifit bone screws are intended to augment the fixation of
compatible acetabular cups,
CODE Lot
# 35323605
RECALLING FIRM/MANUFACTURER Stryker Howmedica
Osteonics Corp., Mahwah, NJ
REASON One lot of 6.5 Cancellous Bone
Screws 25 mm was packaged and labeled as 25 mm in length when it maybe 20 mm in
length.
VOLUME OF PRODUCT IN COMMERCE 29
units
DISTRIBUTION Nationwide
PRODUCT
1) 5 Hole Locking 1st Tarsometatarsal Plate. REF 70-0007-S,
2) 4 Hole Locking 1st Tarsometatarsal Plate. REF
70-0008-S,
3) 4 Hole Locking 2nd and 3rd
Tarsometatarsal Plate. REF 70-0009-S,
4) Left Locking Proximal
Metatarsal Wedge Plate. REF 70-0010-S,
5) Right Locking Proximal
Metatarsal Wedge Plate. REF 70-0011-S,
6) Left Locking Dorsal 1st MTP Fusion Plate. REF
70-0012-S,
7) Left Locking 1st MTP Revision
Fusion Plate. REF 70-0018-S,
8) Right Locking
1st MTP Revision Fusion Plate. REF 70-0019-S,
9) Left Locking 2nd
MTP/MPJ
Combo Fusion Plate. REF 70-0036-S,
10) Right Locking 1st MTP/MPJ Combo Fusion Plate, REF 70-0037-S,
11) 6mm
Bone Graft Drill. Product labeled in part, Size: 6mm Bone Graft Drill... REF BG-8006-S,
12) 10mm Bone Graft Drill. Product labeled in
part, Size: 10mm Bone Graft Drill... REF BG-8020-S,
13)
Locking Clavicle Plate, 10 Holes Large Left. Product labeled in part, REF
PL- CL10LL-S,
14)
Locking Clavicle Plate, 10 Holes Large Right. Product labeled in part, REF
PL- CL10LR-S,
15)
Locking Clavicle Plate, 6 Holes Small Left. REF PL-CL6SL-S,
16) Locking Clavicle Plate, 6
Holes Small Right. REF PL-CL6SR-S,
17) Locking Clavicle Plate, 8 Holes, J-Plate Left.,
REF PL-CL8JL-S,
18) Locking Clavicle Plate, 8 Holes, J-Plate Right. REF PL-CL8JR-S,
19) Locking
Clavicle Plate, 8 Holes Large Left. REF PL-CL8LL-S,
20) Locking Clavicle Plate, 8
Holes Large Right. REF PL-CL8LR-S,
21) Locking Clavicle Plate, 8
Holes Medium Left. REF PL-CL8ML-S,
22) Locking Clavicle
Plate, 8 Holes Medium Right. REF PL-CL8MR-S,
23) Locking Clavicle Plate, 8
Holes Small Right. REF PL-CL8SR-S,
24) Locking Clavicle
Plate, 9 Holes, J-Plate Left. REF PL-CL9JL-S,
25) Locking Clavicle
Plate, 9 Holes, J-Plate Right. REF PL-CL9JR-S,
CODE
1) Work order number/Lot: W58115 (W=work order,
###=sequential number); Expiration date: 2014-11
(Year/Month);
2) Work order number/Lot: W58116 (W=work order, ###=sequential
number); Expiration date: 2014-11 (Year/Month);
3)
Work order number/Lot: W58117 (W=work order, ###=sequential number); Expiration date: 2014-11 (Year/Month);
4) Work order
number/Lot: W58118 (W=work order, ###=sequential number); Expiration date: 2014-11
(Year/Month);
5) Work order number/Lot: W58119 (W=work order,
###=sequential number); Expiration date:
2014-11 (Year/Month);
6) Work order number/Lot: W58120 (W=work order,
###=sequential number); Expiration date:
2014-11 (Year/Month);
7) Work order number/Lot: W58121 (W=work order,
###=sequential number); Expiration date:
2014-11 (Year/Month);
8) Work order number/Lot: W58122 (W=work order,
###=sequential number); Expiration date:
2014-11 (Year/Month);
9) Work order number/Lot: W58123 (W=work order,
###=sequential number); Expiration date:
2014-11 (Year/Month);
10) Work order number/Lot: W58148 (W=work order,
###=sequential number); Expiration date:
2014-11 (Year/Month);
11) Work order number/Lot: W51258 (W=work order,
###=sequential number); Expiration date:
2014-09 (Year/Month);
12) Work order number/Lot: W54076 (W=work order,
###=sequential number); Expiration
date: 2014-10 (Year/Month);
13) Work order number/Lot: W58181 (W=work order,
###=sequential number); Expiration date:
2014-11 (Year/Month);
14) Work order numbers/Lots: W57997and W58182(W=work
order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
15) Work order numbers/Lots: W57683
and W58184 (W=work order, ###=sequential number); Expiration date: 2014-11
(Year/Month)
16) Work order number/Lot: W57684 (W=work order, ###=sequential
number); Expiration date: 2014-11
(Year/Month);
17) Work order numbers/Lots: W57685 and W58187 (W=work order,
###=sequential number); Expiration
date: 2014-11 (Year/Month);
18) Work order number/Lot: W57686 (W=work order,
###=sequential number); Expiration
date: 2014-11 (Year/Month);
19) Work order numbers/Lots: W57687 and W58190
(W=work order, ###=sequential number);
Expiration date: 2014-11 (Year/Month);
20) Work order numbers/Lots: W58192,
W58081, and W57688 (W=work order,
###=sequential number); Expiration date: 2014-11 (Year/Month);
21) Work order
number/Lot: W58194 (W=work order, ###=sequential number); Expiration date: 2014-11 (Year/Month);
22)
Work order number/Lot: W58195 (W=work order, ###=sequential number); Expiration date: 2014-11 (Year/Month);
23)
Work order numbers/Lots: W57689 and W58197 (W=work order, ###=sequential number); Expiration date: 2014-11
(Year/Month);
24) Work order number/Lot: W57690 (W=work order, ###=sequential
number); Expiration date: 2014-11
(Year/Month);
25) Work order number/Lot: W58199 (W=work order, ###=sequential
number); Expiration date: 2014-11
(Year/Month)
RECALLING FIRM/MANUFACTURER Acumed LLC,
Hillsboro, OR
REASON Product sterility may be
compromised.
VOLUME OF PRODUCT IN COMMERCE 268
pieces
DISTRIBUTION Nationwide, UK, Australia, and
Greece
PRODUCT Isoloc Software, Version 6.6, 6.5, and 6.0. Part # MT-NW-425-520.
Software computer hard disc reads “ISOLOC 6.6 Copyright NMPE Copyright 1997-2004
NMPE Build # 10302006 CIVCO Medical Solutions is an EPID-based (electronic
portal imaging device) version of localization software for determining the
treatment machine position of radiotherapy targets, R
CODE Versions 6.6, 6.5 and
6.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Civco
Medical Instruments, Inc., Kalona, IA,
Manufacturer: Northwest Medical Physics Equipment, Inc., Everett, WA.
REASON
A localization
may be produced which has the incorrect moves, and therefore, could place the
patient in the incorrect location.
VOLUME OF PRODUCT IN
COMMERCE 235 units
DISTRIBUTION Nationwide,
Korea, Portugal, and
UK
PRODUCT GE Precision RXi Digital remote X-Ray Imaging R&F System, model
5117828. The product is used for performing general R&F, radiology,
fluoroscopy, interventional and angiography procedures/applications, CODE
Serial numbers: 100, 106, 107, 111, 112,
136, 145, 146, 147, 148, 149, 157, 158, 164, 165, 167, 168, 173, 176, 183, 184,
188, 193, 198, 205, 211, 212, 213, 221, 225, 230, 233, 242, 244, 252, 254, 261,
264, 283, 284, 285, 291, 292, 299, 304, 306, 308, 323, 324, 327, 328, 334, 339,
366, 380, 388, 390, 392, 394, 421, and 426
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI,
Manufacturer: General Medical
Merate,
Seriate, Italy. REASON The Precision RXi collimator did not contain a
label identifying the device as being certified to comply with applicable
requirements of the x-ray performance standard.
VOLUME OF PRODUCT IN
COMMERCE 61 systems
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a) GE Stereotaxy Positioner, model 2405544-2, for use with
Senographe DS Full Field Mammography system, models
2383168, 2383168-2, 2383168-3, 2383168-3-1,
2383168-4-1.
The expected use of the Senographe DS Stereotaxy is an optional accessory for the Senographe system for mammography
examinations,
b) GE Stereotaxy Positioner, model 2405544-3, for use with Senographe DS Full Field Mammography system, models 2383168, 2383168-2, 2383168-3,
2383168-3-1,
2383168-4-1. The expected use of the
Senographe DS Stereotaxy is an optional accessory for the
Senographe system for mammography examinations,
CODE
a) Serial
numbers: 00000434834BU8, 00000434837BU1, 00000437358BU5,
00000437363BU5, 00000437366BU8, 00000437366BU8, 00000444593BU8, 00000444603BU5, 00000450276BU1, 00000450289BU4,
00000454195BU9, 00000454197BU5, 00000454200BU7,
00000454202BU3, 0000046417BU0,
00000464622BU0,
00000464628BU7, 00000484259BU7, 00000484270BU4,
00000484290BU2, 00000484297BU7, 0000048429BU4, 00000492966BU7, 00000492975BU8, 00000494921BU0, 00000500104BU5, and
00000500118BU5;
b) Serial numbers: 00000509762BU1, 00000509764BU7,
00000543767BU8, 00000546136BU3, 00000546140BU5,
00000546772BU5, 00000546793BU1, 00000546794BU9,
00000546799BU8, 00000550251BU3, 00000550265BU3, and
00000550266BU1
RECALLING FIRM/MANUFACTURER
Recalling
Firm: GE Healthcare, Waukesha, WI,
Manufacturer: GE Medical Systems, SCS, Buc Cedex, France.
REASON
GE Healthcare has recently
become aware of x-ray emission beyond the edge of the detector primary barrier.
This issue occurs when an exam is performed in a specific angulated view
associated with use of the Stereotactic Positioner of your Senographe DS
Acquisition system and could impact patient safety. If the Stereotactic
Positioner is removed when the examination arm is at 33 degrees and, the
operator exits the Stereo Medical application, then starts a new examination in
standard mode, this allows the user to perform an acquisition that leads to
x-ray emission beyond the edge of the detector. There have been no reports of
exposure to unintended x-ray emission.
VOLUME OF PRODUCT IN
COMMERCE 39 units
DISTRIBUTION AL, CA, CO,
FL, IL, KS, MA, ME, MN,MO, NC, NJ, NM, NY OK, SC, TN, TX, and
WI
PRODUCT
a) Flexipet Denuding pipette 130 micron. The product is boxed with
5 vials of 10. The device is used for the
intracytoplasmic single sperm injection of oocytes,
b) Flexipet Manipulation pipette 300
micron. The device is used for the intracytoplasmic
single sperm injection of oocytes,
CODE
a) Lot number N74091;
b) Lot number
N74173
RECALLING FIRM/MANUFACTURER Cook Vascular Inc.,
Vandergrift, PA,
REASON Mislabeled - 300 micron flexipets
labeled as 130 micron and vice versa.
VOLUME OF PRODUCT IN
COMMERCE 194 boxes
DISTRIBUTION CA, FL, GA,
IN, NJ, NM, NV, WA, and
WI
PRODUCT
a) Hologic Discovery Bone Densitometers with Apex software versions
2.0, 2.1 and 2.2 is indicated for the estimate of bone
mineral density, comparison of measured
variables
obtained from a given scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body
composition analysis, and
discrimination of bone from
prosthetics,
b) Hologic QDR4500 Bone Densitometers with
Apex software versions 2.0, 2.1 and 2.2 is indicated for
the estimate of bone mineral density, comparison of measured
variables obtained from a given scan to a database of
reference values, the estimation of fracture risk,
vertebral deformity assessment, body composition analysis, and
discrimination of bone from prosthetics,
c) Hologic Delphi Bone Densitometers with Apex software versions
2.0, 2.1 and 2.2 is indicated for the estimate of bone
mineral density, comparison of measured variables
obtained from a given scan to a database of reference values, the estimation of
fracture risk, vertebral deformity assessment, body
composition analysis, and discrimination of bone from
prosthetics,
d) Hologic Explorer Bone Densitometers
with Apex software versions 2.0, 2.1 and 2.2 is indicated
for the estimate of bone mineral density, comparison of measured variables obtained from a given scan to a database of reference
values, the estimation of fracture risk, vertebral
deformity assessment, body composition analysis, and discrimination of bone from prosthetics,
e)
Hologic Oasis Bone Densitometers with Apex software versions 2.0, 2.1 and 2.2 is indicated for the estimate of bone mineral density,
comparison of measured variables
obtained from a given
scan to a database of reference values, the estimation of fracture risk, vertebral deformity assessment, body composition
analysis, and discrimination of bone from prosthetics,
CODE
a) Serial numbers: 83286 83048
83152 83372 83361 83033 83196 83270 83333 83172 83238 83446 83217 83078
83147 83212 83374 83375 83379 83392 83394 83396 83410 83423 80199 80920
83024 83053 83232 83318 83336 83110 83183 83189 83244 83434 83056 83335
83058 83097 83113 83166 83248 83265 83266 83283 83297 83258 83359 83381 83214
83380 83274 83123 83299 83060 83104 83108 83167 83234 83247 83403 83404 83031
83103 83067 83130 83179 83208 83226 83228 83259 83275 83304 83327 83331 83389
83416 83026 83036 83042 83052 83068 83069 83124 83128 83135 83136 83143 83153
83168 83187 83188 83193 83198 83204 83215 83242 83251 83253 83319 83320 83330
83339 83345 83347 83349 83391 83393 83444 83462 83463 83127 83137 83192 83355
83307 83063 83132 83138 83250 83262 83222 83424 83016 83030 83037 83102 83140
83281 83288 83295 83433 83070 83296 83364 83383 83449 83066 83230 83289 83344
83054 83089 83099 83146 83162 82998 83117 83145 83151 83158 83284 83401 83405
83437 83443 83341 83409 83061 83071 83079 83119 83006 83101 83303 83382 83237
83073 83095 83315 82894 82997 83012 83106 83125 83180 83184 83224 83239 83325
83340 83358 83368 83461 83129 83256 83272 83049 83171 83306 83363 83402 82970
83426 83029 83414 83087 83074 82249 80006 83220 82185 83142 83287 82771 83062
83376 83267 83227 80146 83160 83155 83233 83240 83164 83280 80397 83175 83083
80246 82827 83000 83329 83004 80498 83159 82944 83269 83059 83369 83302 83210
83163 83118 83263 81256 83413 82981 80257 82811 83219 81477 83300 83308 83098
83150 83246 82110 83041 83301 83305 81646 82376 83203 83182 83377 83231 83213
83338 83425 83156 83321 83207 83322 83072 82996 83334 83442 83395 83241 83010
82933 83001 83356 82920 82437 81968 83271 83387 83348 81841 83218 83021 83115
80836 83422 83430 83440 83039 83032 83114 81633 83460 83121 83328 83255 83406
83202 83149 81897 83453 83245 83169 83195 83292 82889 82899 83116 83191 83020
83112 83445 83384 83243 83190 83260 80111 83378 83209 83084 80741 82144 83429
83278 83451 83261 81681 80514 83088 83122 83223 82038 81942 83181 83366 83337
83197 83019 82402 81478 83081 83105 83324 83013 83225 83357 81054 83092 83157
83221 83428 83457 83107 83076 83353 83279 83144 83154 83454 83047 83055 83139
83100 83458 83323 82982 83111 83211 83176 83273 83011 83064 82591 83120 81980
83447 83170 83007 83311 83252 83080 81672 83310 82979 82857 83051 83148 83276
80910 83367 83093 83040 83317 83385 82916 80395 83046 83421 83194 83432 83316
83254 83077 83023 83343 83045 81784 81787 82064 82067 83075 83342 83411 83418
83351 81287 83009 83126 83362 83400 83094 83090 83133 83134 83314 83109 83371
83365 82371 83397 83346 83017 83034 83174 83178 83038 83082 83431 83185 83386
83415 83291 83003 83131 83398 83419 83085 83285 83065 83235 83294 83173 81058
83464 82989 82134 83177 83022 83199 83309 83427 83388 83015 83293 82671 83044
81866 83350 82876 83018 83326 80392 82828 83091 83014 83186 83282 83264 83277
83249 81665 80378 83420 83216 82226 83086 82400 80079 80374 83436 81464 82426
83050 83005 83096 82992 82935 81948 82895 83025 83043 83456 82378 83360 83229
83332 80711 83161 83370 83373 83027 83035 83165 83141 83417 83205 83312 83448
83057 83028 82775 83435 83352 83008 83206 83002 80045 83390 80970 81254 83268
83313 and 83200;
b) Serial numbers: 47733C 48128 45692A 45757W 48009C/NCE
48321C/NCE 49477W 50033C 47265C 49113C/CE 49170W/CE 49244C/CE 48815C/NCE 47638C 45801A/CE 47068C 50099C/CE 47758C 48939C 47092C 71239 45100SL
47629C 45273SL 45690SL/CE 47104C 45546A/CE 45744A/CE 45762A/CE 45633A/CE 45442SL
49189C 48783C 48397C/NCE 47763C 45916 49820 49823 49824 47339C 45597SL/CE
45520A/CE 47712C 48157W/CE 47501C 45352SL 48242C/NCE 45853SL/CE 45837SL/CE
47679C 48781C/NCE 48579C 47443 48610C 49423W/CE 49792C/CE 45434SL/CE 49848
47197C 48781C/NCE 47159W 45264 48224 45264A 45759 45759SL/CE 49404C/CE
45708SL/CE 45935SL/CE 48220W/CE 48269C/NCE 47478NCE 49194 48953C/NCE 45479A/CE
45640A/CE 49179 49576C 45496A/CE 45158SL/CE 45537A/CE 45553SL/CE 48789 47034W
45860SL/CE 45197A 45573SL/CE 50051C/CE 47822 49034W/CE 47512C 45674SL 48280C/NCE
48204W/CE 47345C 47677C/CE 45486 48063C 45550SL/CE 48064C/NCE 45668A/CE
49349C/CE 49259C/CE 47564C 47641C 48240C/NCE 49386 45523A/CE 45941SL/CE
45782SL/CE 47061C 47105C 48106C/NCE 49351C/CE 45498A/CE 48384C/NCE 45811SL/CE
49286C/CE 45443SL/CE 48231C/NCE 45492SL/CE 49367C/CE 48858C/NCE 47703C
45688SL/CE 49270W/CE 47262C 47710C 48431C/NCE 49124C/CE 48004C 45620SL/CE
48221W/CE 48963C/NCE 45495SL/CE 49366C/CE 49287C/CE 48990C/NCE 45556A/CE 47435C
45241A 45115A 48958C/NCE 48229C/NCE 45842A/CE 45247A 48899C/NCE 45816A/CE 45104
48021C/NCE 45659A/CE 47760C 45214A and 45725A/CE
c) Serial numbers:
70411W 70456W 71132C 71205W 70007C 70024C 70102C 70129C 70138C 70351C 70379A
70394A 70395C 70414A 70415A 70418A 70419A 70421A 70434W 70512A 70525W 70545W
70561W 70603W 70609C 70677C 70678W 70717C 70721W 70724A 70734A 70744C 70761C
70791C 70817W 70824C 70845C 70855SL 70896SL 70987W 71016C 71035W 71076C 71091C
71151C 71172SL 71188C 71223C 71231W 71239C 71255W 71257C 71287C 71342C and
71386C;
d) Serial numbers: 91108 90941 91022 90952 91032 91127 91126
91193 91065 90885 91222 91070 91141 91057 90970 90969 91107 91050 91013 91014
91015 91016 91017 91018 91019 91020 91043 91044 91045 91046 91047 91048 91049
91151 91152 91153 91154 91155 91213 91214 91215 91218 91238 91239 91240 91241
91242 91243 91253 91254 91256 91257 91262 91263 91265 91266 91268 91269 91051
91099 91165 91100 91143 91054 91012 91039 91076 91258 91224 91260 91261 90920
90924 90934 90938 90923 91028 91029 91031 91026 91030 91113 91114 91128 91180
91186 91187 91183 91210 91212 91226 91208 91227 91229 91252 91034 91205 91281
91111 91211 91202 91228 90939 90945 90953 90971 90972 90942 90976 90995 90996
91009 91033 91036 91060 91071 91072 91068 91069 91059 91105 91106 91118 91123
91124 91133 91137 91138 91181 91182 91221 91223 91225 91259 91283 90911 90978
90994 91066 91103 91104 91125 91250 91064 91075 90988 91174 91271 91109 91110
91132 91135 91184 91094 90954 90955 90956 90957 90958 91097 91098 91101 91102
91136 91146 91147 91148 91149 91150 90977 90984 90985 90986 90987 90997 90998
90999 91001 91002 91003 91007 91008 91052 91053 91055 91077 91078 91079 91080
91085 91086 91087 91157 91158 91159 91198 91199 91168 91169 91170 91171 91172
91093 91167 91173 91176 91177 91234 91235 91236 91179 91237 91244 91245 91264
91275 91276 91277 91278 91279 91207 90992 91006 91063 91084 91119 91161 91232
91246 91255 90982 91142 90993 91062 91083 91120 91121 91122 91130 91145 91160
91162 91163 91164 91196 91247 91248 91273 91274 91185 91190 91027 91156 91280
91203 91042 91081 91082 91131 91233 91061 91021 91000 91004 91267 91067 90990
91134 90937 91140 91197 91175 91091 90981 91117 91178 91209 91251 90940 90980
90983 91035 91115 91144 91231 91092 91249 91270 91272 91010 91011 90979 90991
90989 91025 91056 91058 91088 91089 91090 91095 91096 91112 91116 91139 91188
91192 91194 91189 91204 91191 91195 91230 91206 91005 91040 91200 91201 91216
91217 91219 91220 91166 91037 and 91038;
e) Serial numbers: 11/01/06 B
1/04/08B 11/01/06 A 6/24/05-A 9/25/06-01 9/25/06-02 9/25/06-03 9/25/06-04
9/28/06-01 9/28/06-02 9/28/06-03 9/12/07B 10/02/07B 10/02/07A and 1/04/08A
RECALLING FIRM/MANUFACTURER Hologic, Inc., Bedford, MA,
REASON
Software densitometer readings for left
hip and lumbar spine under certain conditions may be
inaccurate.
VOLUME OF PRODUCT IN COMMERCE 1,168
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Plastic Cannula
Holdex® Tube Holder, Item number: 450216. It is
intended for use in routine specimen withdrawal from specimen collection bags or
bottles through needleless cannula ports,
CODE Lot#: A030804
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Greiner Bio-One North America,
Inc., Monroe, NC,
Manufacturer: Greiner
Bio-One Gmbh, Kremsmunster, Austria.
REASON At removal of the tube from the holder the needle
may dislodge and become stuck in the tube stopper with the blunt end of the
needle facing out.
VOLUME OF PRODUCT IN COMMERCE 150,000
pieces
DISTRIBUTION AL, FL, IN, KS, KY, MO, MN, NC, OH,
PA, TN, TX, UT, VA, WI and
WV
PRODUCT MEDTOXscan Reader. Product number: 833062,
CODE
Product number only
RECALLING
FIRM/MANUFACTURER Medtox Diagnostics, Inc., Burlington, NC,
REASON
Reader was marketed without a
510(k).
VOLUME OF PRODUCT IN COMMERCE 391
Readers
DISTRIBUTION Nationwide
PRODUCT Acuson
CV70 Ultrasound systems Ultrasonic Pulsed echo/doppler imaging system with
Software revisions less than 4.0.0b, material number 784539, 7848521, and
7848547. Is a general purpose, mobile, software-controlled, diagnostic
ultrasound system with an on-screen display for thermal and mechanical indices
related to potential bioeffect mechanisms,
CODE
Serial numbers: AHE0824 D855 HA0771
HAA0008 HAA0101 HAA0102 HAA0103 HAA0104 HAA0105 HAA0106 HAA0107 HAA0108 HAA0109
HAA0110 HAA0111 HAA0112 HAA0113 HAA0114 HAA0115 HAA0116 HAA0117 HAA0118 HAA0119
HAA0120 HAA0121 HAA0122 HAA0123 HAA0124 HAA0125 HAA0126 HAA0127 HAA0128 HAA0129
HAA0130 HAA0132 HAA0133 HAA0134 HAA0135 HAA0136 HAA0137 HAA0138 HAA0139 HAA0140
HAA0141 HAA0142 HAA0143 HAA0144 HAA0146 HAA0147 HAA0148 HAA0149 HAA0150 HAA0151
HAA0152 HAA0153 HAA0154 HAA0155 HAA0156 HAA0157 HAA0158 HAA0159 HAA0160 HAA0161
HAA0162 HAA0163 HAA0164 HAA0166 HAA0167 HAA0168 HAA0169 HAA0170 HAA0171 HAA0172
HAA0173 HAA0174 HAA0176 HAA0177 HAA0178 HAA0179 HAA0180 HAA0181 HAA0182 HAA0183
HAA0184 HAA0185 HAA0186 HAA0187 HAA0188 HAA0189 HAA0190 HAA0191 HAA0192 HAA0193
HAA0194 HAA0195 HAA0196 HAA0197 HAA0198 HAA0199 HAA0200 HAA0201 HAA0202 HAA0203
HAA0204 HAA0205 HAA0206 HAA0208 HAA0209 HAA0210 HAA0211 HAA0212 HAA0213 HAA0214
HAA0215 HAA0216 HAA0217 HAA0218 HAA0219 HAA0222 HAA0224 HAA0225 HAA0231 HAA0244
HAA0245 HAA0246 HAA0247 HAA0248 HAA0250 HAA0262 HAA0263 HAA0265 HAA0266 HAA0267
HAA0268 HAA0269 HAA0270 HAA0271 HAA0272 HAA0273 HAA0274 HAA0275 HAA0276 HAA0278
HAA0279 HAA0280 HAA0282 HAA0283 HAA0284 HAA0285 HAA0286 HAA0287 HAA0289 HAA0290
HAA0291 HAA0292 HAA0294 HAA0296 HAA0297 HAA0298 HAA0299 HAA0300 HAA0301 HAA0302
HAA0303 HAA0304 HAA0305 HAA0306DEL HAA0307 HAA0308 HAA0309 HAA0310 HAA0311
HAA0312 HAA0314 HAA0315 HAA0316 HAA0317 HAA0318 HAA0319 HAA0320 HAA0322 HAA0324
HAA0326 HAA0327 HAA0328 HAA0329 HAA0331 HAA0333 HAA0334 HAA0335 HAA0336 HAA0338
HAA0340 HAA0341 HAA0342 HAA0343 HAA0344 HAA0346 HAA0347 HAA0348 HAA0351 HAA0352
HAA0353 HAA0354 HAA0355 HAA0356 HAA0357 HAA0358 HAA0359 HAA0360 HAA0361 HAA0363
HAA0365 HAA0366 HAA0367 HAA0368 HAA0369 HAA0371 HAA0372 HAA0373 HAA0375 HAA0376
HAA0377 HAA0378 HAA0379 HAA0380 HAA0382 HAA0383 HAA0384 HAA0386 HAA0387 HAA0388
HAA0389 HAA0390 HAA0391 HAA0392 HAA0393 HAA0395 HAA0398 HAA0399 HAA0400 HAA0401
HAA0402 HAA0403 HAA0404 HAA0405 HAA0406 HAA0407 HAA0408 HAA0409 HAA0410 HAA0411
HAA0412 HAA0413 HAA0414 HAA0415 HAA0416 HAA0417 HAA0418 HAA0419 HAA0420 HAA0421
HAA0422 HAA0423 HAA0424 HAA0425 HAA0426 HAA0429 HAA0430 HAA0431 HAA0432 HAA0433
HAA0434 HAA0436 HAA0437 HAA0438 HAA0439 HAA0440 HAA0441 HAA0442 HAA0443 HAA0445
HAA0446 HAA0449 HAA0452 HAA0453 HAA0454 HAA0456 HAA0457 HAA0458 HAA0459 HAA0460
HAA0461 HAA0462 HAA0463 HAA0464 HAA0465 HAA0466 HAA0467 HAA0468 HAA0469 HAA0470
HAA0472 HAA0473 HAA0474 HAA0475 HAA0477 HAA0478 HAA0480 HAA0481 HAA0482 HAA0483
HAA0484 HAA0485 HAA0486 HAA0487 HAA0489 HAA0490 HAA0491 HAA0492 HAA0493 HAA0494
HAA0495 HAA0496 HAA0497 HAA0498 HAA0499 HAA0500 HAA0501 HAA0502 HAA0503 HAA0504
HAA0505 HAA0506 HAA0507 HAA0508 HAA0509 HAA0510 HAA0511 HAA0512 HAA0514 HAA0515
HAA0516 HAA0517 HAA0518 HAA0519 HAA0520 HAA0521 HAA0523 HAA0524 HAA0525 HAA0526
HAA0527 HAA0528 HAA0529 HAA0530 HAA0531 HAA0532 HAA0533 HAA0534 HAA0535 HAA0536
HAA0537 HAA0538 HAA0539 HAA0540 HAA0541 HAA0542 HAA0543 HAA0544 HAA0545 HAA0546
HAA0547 HAA0548 HAA0549 HAA0550 HAA0551 HAA0552 HAA0553 HAA0554 HAA0555 HAA0556
HAA0566 HAA0569 HAA0570 HAA0571 HAA0572 HAA0573 HAA0574 HAA0575 HAA0576 HAA0577
HAA0578 HAA0579 HAA0580 HAA0581 HAA0582 HAA0583 HAA0584 HAA0585 HAA0587 HAA0588
HAA0589 HAA0590 HAAX0114 HAAX0131 HAAX0145 HAAX0184 HAAX0207 HAAX0216 HAAX0235
HAAX0273 HAAX0274 HAAX0277 HAAX0281 HAAX0288 HAAX0295 HAAX0321 HAAX0323 HAAX0332
HAAX0337 HAAX0345 HAAX0350 HAAX0364 HAAX0396 HAAX0397 HAAX0476 HAAX0479 HAAX0488
HAE0002 HAE0003 HAE0004 HAE0005 HAE0006 HAE002 HAE003 HAE005 HAE0101 HAE0102
HAE0103 HAE0104 HAE0105 HAE0106 HAE0107 HAE0108 HAE0109 HAE0110 HAE0111 HAE0112
HAE0113 HAE0114 HAE0115 HAE0116 HAE0117 HAE0118 HAE0119 HAE0120 HAE0121 HAE0122
HAE0123 HAE0124 HAE0125 HAE0126 HAE0127 HAE0128 HAE0129 HAE0130 HAE0131 HAE0132
HAE0133 HAE0134 HAE0135 HAE0136 HAE0137 HAE0138 HAE0139 HAE0140 HAE0141 HAE0142
HAE0143 HAE0145 HAE0146 HAE0147 HAE0148 HAE0149 HAE0150 HAE0151 HAE0152 HAE0153
HAE0154 HAE0155 HAE0156 HAE0157 HAE0158 HAE0159 HAE0160 HAE0161 HAE0162 HAE0163
HAE0164 HAE0165 HAE0166 HAE0167 HAE0168 HAE0169 HAE0170 HAE0171 HAE0172 HAE0173
HAE0174 HAE0175 HAE0176 HAE0177 HAE0178 HAE0179 HAE0180 HAE0181 HAE0182 HAE0183
HAE0184 HAE0185 HAE0186 HAE0187 HAE0188 HAE0189 HAE0190 HAE0191 HAE0192 HAE0193
HAE0194 HAE0195 HAE0196 HAE0197 HAE0198 HAE0199 HAE0200 HAE0201 HAE0202 HAE0203
HAE0204 HAE0205 HAE0206 HAE0207 HAE0208 HAE0209 HAE0210 HAE0211 HAE0212 HAE0213
HAE0214 HAE0215 HAE0216 HAE0217 HAE0218 HAE0219 HAE0220 HAE0221 HAE0222 HAE0223
HAE0224 HAE0225 HAE0226 HAE0227 HAE0228 HAE0229 HAE0230 HAE0231 HAE0232 HAE0233
HAE0234 HAE0235 HAE0236 HAE0237 HAE0239 HAE0240 HAE0241 HAE0242 HAE0243 HAE0244
HAE0245 HAE0246 HAE0247 HAE0248 HAE0249 HAE0250 HAE0251 HAE0252 HAE0253 HAE0254
HAE0255 HAE0256 HAE0257 HAE0258 HAE0259 HAE0260 HAE0261 HAE0262 HAE0263 HAE0264
HAE0265 HAE0266 HAE0267 HAE0268 HAE0269 HAE0270 HAE0271 HAE0272 HAE0273 HAE0274
HAE0275 HAE0276 HAE0278 HAE0279 HAE0280 HAE0281 HAE0282 HAE0283 HAE0284 HAE0285
HAE0286 HAE0287 HAE0288 HAE0289 HAE0290 HAE0291 HAE0292 HAE0293 HAE0294 HAE0295
HAE0296 HAE0297 HAE0298 HAE0299 HAE0300 HAE0301 HAE0302 HAE0303 HAE0304 HAE0305
HAE0306 HAE0307 HAE0308 HAE0309 HAE0310 HAE0311 HAE0312 HAE0313 HAE0314 HAE0315
HAE0316 HAE0317 HAE0318 HAE0319 HAE0320 HAE0321 HAE0322 HAE0323 HAE0324 HAE0325
HAE0326 HAE0328 HAE0329 HAE0330 HAE0331 HAE0332 HAE0333 HAE0334 HAE0335 HAE0336
HAE0337 HAE0338 HAE0339 HAE0340 HAE0341 HAE0342 HAE0343 HAE0345 HAE0346 HAE0347
HAE0348 HAE0349 HAE0350 HAE0351 HAE0352 HAE0353 HAE0354 HAE0355 HAE0356 HAE0357
HAE0358 HAE0359 HAE0360 HAE0361 HAE0362 HAE0363 HAE0364 HAE0365 HAE0366 HAE0367
HAE0368 HAE0369 HAE0370 HAE0371 HAE0372 HAE0373 HAE0374 HAE0375 HAE0376 HAE0377
HAE0378 HAE0379 HAE0380 HAE0381 HAE0382 HAE0383 HAE0384 HAE0385 HAE0386 HAE0387
HAE0388 HAE0389 HAE0390 HAE0391 HAE0392 HAE0394 HAE0395 HAE0396 HAE0397 HAE0398
HAE0399 HAE0400 HAE0401 HAE0402 HAE0403 HAE0404 HAE0405 HAE0407 HAE0408 HAE0409
HAE0411 HAE0412 HAE0413 HAE0414 HAE0415 HAE0416 HAE0417 HAE0418 HAE0419 HAE0420
HAE0421 HAE0422 HAE0423 HAE0424 HAE0425 HAE0426 HAE0427 HAE0428 HAE0429 HAE0431
HAE0432 HAE0433 HAE0434 HAE0435 HAE0436 HAE0437 HAE0438 HAE0439 HAE0441 HAE0442
HAE0443 HAE0444 HAE0445 HAE0446 HAE0447 HAE0448 HAE0449 HAE0450 HAE0451 HAE0452
HAE0453 HAE0456 HAE0457 HAE0458 HAE0459 HAE0460 HAE0461 HAE0462 HAE0463 HAE0464
HAE0465 HAE0466 HAE0467 HAE0468 HAE0469 HAE0471 HAE0472 HAE0473 HAE0474 HAE0475
HAE0476 HAE0477 HAE0478 HAE0479 HAE0480 HAE0481 HAE0482 HAE0483 HAE0484 HAE0485
HAE0486 HAE0487 HAE0488 HAE0489 HAE0490 HAE0491 HAE0492 HAE0493 HAE0494 HAE0495
HAE0496 HAE0497 HAE0498 HAE0499 HAE0500 HAE0501 HAE0502 HAE0503 HAE0505 HAE0506
HAE0507 HAE0508 HAE0509 HAE0510 HAE0511 HAE0512 HAE0513 HAE0514 HAE0515 HAE0516
HAE0517 HAE0518 HAE0519 HAE0520 HAE0521 HAE0522 HAE0523 HAE0524 HAE0525 HAE0526
HAE0527 HAE0528 HAE0529 HAE0530 HAE0531 HAE0532 HAE0533 HAE0534 HAE0535 HAE0536
HAE0537 HAE0538 HAE0539 HAE0540 HAE0541 HAE0542 HAE0543 HAE0544 HAE0545 HAE0546
HAE0547 HAE0548 HAE0549 HAE0550 HAE0551 HAE0552 HAE0553 HAE0554 HAE0555 HAE0556
HAE0557 HAE0558 HAE0559 HAE0560 HAE0561 HAE0562 HAE0563 HAE0564 HAE0565 HAE0566
HAE0567 HAE0568 HAE0569 HAE0570 HAE0571 HAE0572 HAE0573 HAE0574 HAE0575 HAE0576
HAE0577 HAE0578 HAE0579 HAE0580 HAE0581 HAE0582 HAE0583 HAE0584 HAE0585 HAE0586
HAE0587 HAE0588 HAE0589 HAE0590 HAE0591 HAE0592 HAE0593 HAE0594 HAE0595 HAE0596
HAE0597 HAE0598 HAE0599 HAE0600 HAE0601 HAE0602 HAE0603 HAE0604 HAE0605 HAE0606
HAE0607 HAE0608 HAE0609 HAE0610 HAE0611 HAE0612 HAE0613 HAE0614 HAE0615 HAE0616
HAE0617 HAE0618 HAE0619 HAE0620 HAE0621 HAE0622 HAE0623 HAE0624 HAE0625 HAE0626
HAE0627 HAE0628 HAE0629 HAE0630 HAE0631 HAE0632 HAE0633 HAE0634 HAE0635 HAE0636
HAE0637 HAE0638 HAE0639 HAE0640 HAE0641 HAE0642 HAE0643 HAE0644 HAE0645 HAE0646
HAE0647 HAE0648 HAE0649 HAE0650 HAE0651 HAE0652 HAE0653 HAE0654 HAE0655 HAE0656
HAE0657 HAE0658 HAE0659 HAE0660 HAE0661 HAE0662 HAE0663 HAE0664 HAE0665 HAE0666
HAE0667 HAE0668 HAE0669 HAE0670 HAE0671 HAE0672 HAE0673 HAE0675 HAE0676 HAE0677
HAE0678 HAE0679 HAE0680 HAE0681 HAE0682 HAE0683 HAE0684 HAE0685 HAE0686 HAE0687
HAE0688 HAE0689 HAE0690 HAE0691 HAE0692 HAE0693 HAE0694 HAE0695 HAE0696 HAE0697
HAE0698 HAE0699 HAE0700 HAE0701 HAE0702 HAE0703 HAE0704 HAE0705 HAE0706 HAE0707
HAE0708 HAE0709 HAE0710 HAE0711 HAE0712 HAE0713 HAE0714 HAE0715 HAE0716 HAE0717
HAE0718 HAE0719 HAE0720 HAE0721 HAE0722 HAE0723 HAE0724 HAE0725 HAE0726 HAE0727
HAE0728 HAE0729 HAE0730 HAE0731 HAE0732 HAE0733 HAE0734 HAE0735 HAE0736 HAE0737
HAE0738 HAE0739 HAE0740 HAE0741 HAE0742 HAE0743 HAE0744 HAE0745 HAE0746 HAE0747
HAE0748 HAE0749 HAE075 HAE0750 HAE0751 HAE0752 HAE0753 HAE0754 HAE0755 HAE0756
HAE0757 HAE0758 HAE0759 HAE0760 HAE0761 HAE0762 HAE0763 HAE0764 HAE0765 HAE0766
HAE0767 HAE0768 HAE0769 HAE0770 HAE0772 HAE0773 HAE0774 HAE0775 HAE0776 HAE0777
HAE0778 HAE0779 HAE0780 HAE0781 HAE0782 HAE0783 HAE0784 HAE0785 HAE0786 HAE0787
HAE0788 HAE0789 HAE0790 HAE0791 HAE0792 HAE0793 HAE0795 HAE0796 HAE0797 HAE0798
HAE0799 HAE0800 HAE0801 HAE0802 HAE0803 HAE0804 HAE0805 HAE0806 HAE0807 HAE0808
HAE0809 HAE0810 HAE0811 HAE0812 HAE0813 HAE0814 HAE0815 HAE0816 HAE0817 HAE0818
HAE0819 HAE0820 HAE0821 HAE0822 HAE0823 HAE0826 HAE0827 HAE0828 HAE0829 HAE0830
HAE0831 HAE0832 HAE0835 HAE0837 HAE0838 HAE0839 HAE0840 HAE0841 HAE0842 HAE0843
HAE0844 HAE0845 HAE0846 HAE0847 HAE0848 HAE0849 HAE0850 HAE0851 HAE0852 HAE0853
HAE0854 HAE0855 HAE0856 HAE0857 HAE0859 HAE0860 HAE0862 HAE0863 HAE0864 HAE0865
HAE0866 HAE0867 HAE0868 HAE0869 HAE0870 HAE0871 HAE0872 HAE0873 HAE0874 HAE0875
HAE0876 HAE0877 HAE0878 HAE0879 HAE0880 HAE0881 HAE0882 HAE0883 HAE0884 HAE0885
HAE0886 HAE0887 HAE0888 HAE0889 HAE0890 HAE0891 HAE0892 HAE0895 HAE0896 HAE0897
HAE0899 HAE0900 HAE0901 HAE0902 HAE0903 HAE0904 HAE0905 HAE0906 HAE0907 HAE0908
HAE0911 HAE0914 HAE1047 HAE1052 HAE1053 HAE1103 HAE1106 HAE42466 HAJ0106 HEE0325
HUJ0105
RECALLING FIRM/MANUFACTURER Siemens Medical
Solutions USA, Inc, Mountain View, CA,
REASON System may either
display incorrect mechanical and thermal index values, or fail to display them
altogether.
VOLUME OF PRODUCT IN COMMERCE 1,230
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Metal
Hemiarthroplasty, MDL E536687, Part # 03-6000-1, 03-6000-02,
03-600-03, 03-6000-04. Hemi is designed to supplement first metatarsal
Phalangeal joint arthroplasty,
CODE
Lot numbers: OP-1628, OP-1620, OP-1550,
OP-1549, OP-1545, OP-1525, OP-1524, OP-1523, OP-1522, OP-1521, OP-1520, OP-1519,
OP-1426, OP-1425, OP-1424, OP-1423, OP-1422, OP-1421, OP-1419, OP-1420, and
07-0310
RECALLING FIRM/MANUFACTURER
Recalling Firm:
OrthoPro LLC, Salt Lake City, UT, Manufacturer: Thortex (Malaysia) Sdn
Bhd, Penang, Malaysia.
REASON Labeling presented
conflicting information as to whether device was sterile or
not.
VOLUME OF PRODUCT IN COMMERCE 210
implants
DISTRIBUTION AZ, CA, CO, FL, HI, IL, IN, MI, NY,
OH, OR, PA, RI, TX, UT, VA, and
WA
PRODUCT Reflex
Revision Screwdriver Inner Shaft is an orthopedic manual surgical instrument
that is a nonpowered, hand held device intended for medical purposes to
manipulate tissue or for use with other devices in orthopedic surgery. Ref
Number 48500900; Non Sterile,
CODE Lot codes: 26719, 047377, 047570,
065167, 06A167, and 072689
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Spine, Allendale, NJ,
Manufacturer: Stryker Spine,
Cestas, Aquitane, France. REASON The Inner Shaft does not extend far enough from
the tip of the Revision Screwdriver to fully engage the bone
screw.
VOLUME OF PRODUCT IN COMMERCE 35
units
DISTRIBUTION Nationwide
PRODUCT ARCHITECT i1000SR System Assay CD ROM WW (excluding US) Special
edition Version 1.01 and Version 2.0; list 01P61-01 and 01P61-02. The device is
intended to duplicate manual analytical procedures by performing automatically
various steps such as pipetting, preparing filtrates, heating, and measuring
color intensity, CODE Lot number:
63062P100
RECALLING FIRM/MANUFACTURER Abbott
Laboratories, Abbott Park, IL
REASON When running the Automated Dilution
Protocol with the assay files "CMV IgG" or "Toxo IgG" on the ARCHITECT i1000SR
system, a software error [9010 (Pipettor Robotics) preventing (Process Path)
from operating] is generated and the instrument stops running. No results are
generated.
VOLUME OF PRODUCT IN COMMERCE 75
CD-ROMS
DISTRIBUTION Austria, Belgium, Czech Republic,
Denmark, France, Germany, Iceland, India, Italy, Latvia, Lithuania, Netherlands,
Poland, Portugal, Sweden, Saudi Arabia, Spain, United Arab
Emirates
PRODUCT Medtronic SPECIFY, 3998, Lead Kit for Spinal Cord Stimulation
(SCS). Contents of the inner package are STERILE. Method of sterilization:
Ethylene Oxide. Model 3998 lead is an implantable, permanent lead. It is used to
deliver electrical pulses to the dorsal aspect of the spinal cord. The lead
consists of two polyurethane lead bodies joined to one silicone rubber paddle.
The lead has two parallel rows of four platinum iridium electrodes on the distal
end,
CODE
Serial Numbers: V004442,
V004456, V004457, V004541, V004644, V005789, V005838, V005884, V005952, V006010,
V006011, V006497, V006610, V006732, V006888, V006937, V007136, V007224, V007342,
V007451, V007565, V007729, V007781, V007911, V008174, V008257, V008387, V008638,
V008639, V008729, V008902, V009060, V009191, V009278, V009352, V009353, V009630,
V010099, V010124, V010125, V010366, V010367, V010602, V010744, V010896, V011057,
V011091, V011215, V011257, V011299, V011406, V011457, V011552, V011610, V011627,
V011860, V011958, V011977, V012040, V012123, V012202, V012238, V012260, V012411,
V012571, V012618, V012935, V013158, V013231, V013331, V013489, V013615, V013745,
V013787, V013837, V013862, V014190, V014320, V014426, V014454, V014660, V014785,
V015071, V015166, V015327, V015626, V016195, V016445, V016489, V017182, V017731,
V017927, V019145, V019452, V019569, V019909, V020188, V020688, V020904, V021560,
V021753, V022880, V023339, V023517, V025268, V025500, V025707, V026020, V026436,
V027462, V027804, V028474, V029383, V029983, V030442, V031317, V032070, V032560,
V034825, V034832, V035769, V036156, V036810, V036857, V038530, V041066, V041365,
V042627, V043757, V043759, V044336, V044850, V045723, V047365, V050371, V052566,
V053142, V054607, V056045, V057371, V060415, V062321, V068860, V069647, V077531,
V080086, V082162, V084570, V086942, V090294, V091959, V095777,
V102426
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtronic Neuromodulation, Minneapolis, MN,
Manufacturer: Medtronic Puerto Rico Inc.,
Villalba, PR. REASON Package mislabeling
issue. The package labeling incorrectly states the lead length is 28 cm in
length when it should state 20 cm.
VOLUME OF PRODUCT IN
COMMERCE 3669 (however only 962 units are scope of recall, because
they are sold or in consignment and are not registered
implants
DISTRIBUTION Nationwide
PRODUCT Zimmer NEXGEN Complete Knee Solution MIS Total Knee Procedure
Tibial Broach Impactor (a pounding instrument used during knee surgery),
nonsterile; REF 5951-90,
CODE All
units
RECALLING FIRM/MANUFACTURER Zimmer, Inc., Warsaw,
IN,
REASON The instrument may fracture during use,
resulting in metal fragments being left in the patient post-surgery, which could
cause implant failure.
VOLUME OF PRODUCT IN
COMMERCE 1,439 units
DISTRIBUTION Nationwide,
Australia, China, England, France, Germany, India, Italy, Japan, Korea,
Singapore and Taiwan
PRODUCT Abiomed: Abiocor Implantable Heart Replacement Kit System; Catalog
Number: 0034-8401-HD. The product is intended to be implanted in the thoracic
cavity and replaces operation and function of the native heart,
CODE
Serial Number:
1028043
RECALLING FIRM/MANUFACTURER Abiomed, Inc.,
Danvers, MA,
REASON Subassembly incorrectly
aligned.
VOLUME OF PRODUCT IN COMMERCE 1
unit
DISTRIBUTION NJ
PRODUCT Flexiflo Quantum Pump Set with Piercing Pin and Flush Bag The
product is used with Quantum pump to deliver ready-to-hang (RTH) product in
enterally-fed patients. List #50604,
CODE Lot #47822RY Use By DEC 2009
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Abbott Laboratories, Columbus, OH,
Manufacturer: Abbott Ireland,
Sligo, Ireland.
REASON Product was
incorrectly labeled as “Top-Fill Enteral Nutrition Bag” instead of “Flexiflo
Quantum Pump Set.
VOLUME OF PRODUCT IN COMMERCE 57,120
units
DISTRIBUTION Nationwide
PRODUCT ArthroCare ArthroWand Covator with Integrated Cable Wand, Catalog
number AC4340-01. The product is a medical device for human use in
electrosurgical cutting and coagulation accessories. Product is indicated for
resection, ablation and coagulation of soft tissue and hemostasis of blood
vessels in arthroscopic and orthopedic procedures,
CODE
Lot numbers: C401580-A, C401770-A,
C405180-A, C409550-A, C411570-A, C412350-A, C415070-A, C415970-A, C416150-A,
C423570-A, C424960-A, C430270-A, C432770-A, C434670-A
RECALLING
FIRM/MANUFACTURER ArthroCare Corp., Sunnyvale, CA,
REASON
Product is not secure in packaging, and
movement may damage the product or render it non-sterile.
VOLUME OF
PRODUCT IN COMMERCE 3,644
units
DISTRIBUTION Nationwide, Australia, Germany, Italy,
UK, Austria, Netherlands, Switzerland, Denmark, South Africa, Finland,
Singapore, Spain, Russia and
Poland
PRODUCT AMO WaveScan WaveFront System Version 3.90/3.901, Part Number
0070-1478. The device is used in conjunction with the VISX STAR S4 and STAR S4
IR Excimer Laser Systems, which are indicated for wavefront-guided laser
assisted in situ keratomileusis (LASIK) eye surgery in certain patient
populations. The WaveScan System is a diagnostic instrument intended for the
automated measurement, analysis and recording of refractive errors of the eye.
CODE
Serial Numbers: 10560 70250
70594 75133 12280 70252 70608 75137 14480 70259 70620 75172 70026 70260 70647
75183 70029 70261 70653 75192 70032 70267 70654 75198 70049 70268 70664 75233
70050 70271 70679 75241 70053 70274 70681 75248 70064 70278 70685 75263 70068
70279 70689 75267 70070 70328 70696 75276 70079 70334 70699 75278 70080 70354
70706 75280 70082 70362 70716 75297 70089 70366 70732 75301 70094 70376 70746
75305 70096 70386 70755 75354 70098 70391 70765 75401 70099 70406 70769 75412
70102 70421 70779 75445 70107 70425 70784 76014 70113 70427 70803 76062 70114
70429 70834 76080 70120 70451 70851 76105 70122 70453 70862 76117 70125 70456
70879 76118 70127 70475 70882 76190 70133 70495 70889 76195 70140 70496 70890
76216 70146 70497 75023 76217 70148 70501 75031 76223 70158 70504 75037 76233
70166 70506 75040 76259 70185 70512 75058 76273 70188 70537 75065 76274 70189
70539 75102 76356 70208 70548 75103 76384 70232 70549 75121 70241 70587 and
75126
RECALLING FIRM/MANUFACTURER
Recalling Firm: VISX
Inc., a Subsidiary of AMO, Inc., Santa Clara, CA,
Manufacturer: AMO Manufacturing USA,
LLC, Milpitas, CA.
REASON Inaccurate
measurements may be generated by the device, which could result in improper
treatment and deterioration of patient eyesight.
VOLUME OF PRODUCT IN
COMMERCE 160 software
kits
DISTRIBUTION Nationwide
PRODUCT Advantage
Workstation version 4.2P, 4.3 and 4.4 with Volume Viewer 2 and Volume Viewer 3.
Model Numbers 5183652 & 5142878,
CODE
Serial Numbers: 00000004592AW2
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RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI,
Manufacturer: GE Medical Systems,
SCS, Buc Cedex, France.
REASON A possible mismatch between the label of the
tracked vessel and the underlying image associated with the cardio- vascular
applications of the Advantage workstation that may impact patient
safety.
VOLUME OF PRODUCT IN COMMERCE 5,249
units
DISTRIBUTION Nationwide and Internationally
PRODUCT The St.
Jude Medical Livewire TC" Ablation Catheter, 8mm Tip w/Thermocouple &
Thermistor REF 402196, Length 115 cm, Sterile EO The St. Jude Medical Livewire
TC" Ablation Catheter is a flexible electrode catheter constructed of a
radiopaque polyurethane insulation/shaft and incorporated platinum electrode.
The distal tip portion may be deflected by a remote control handle located a t
the proximal end of t the catheter,
CODE Lot # 2056960
RECALLING
FIRM/MANUFACTURER St. Jude Medical Cardiovascular Division,
Minnetonka, MN
REASON The product was mis-labelled as having an
8 mm tip instead of 4 mm tip. This could potentially result in elevated
temperatures and formation of coagulum at the tip electrode. If this coagulum
were to detach from the product, the worst case this could potentially result in
embolization.
VOLUME OF PRODUCT IN COMMERCE 39
devices
DISTRIBUTION Canada and
Belgium
PRODUCT Spacelabs Medical Temperature Probe Adaptor PN-700-0031-00. Device
is packaged in clear plastic bags with an attached insert card Insert card reads
"TruLink series Dual Temperature Cable REF 700-0032-00”,
CODE Lot numbers: OSC 01/07, OSC 02/07, OSC 03/07, OSC
04/07 and OSC 07/07
RECALLING FIRM/MANUFACTURER Spacelabs
Healthcare, Inc., Issaquah, WA, .
REASON Intermittent contact of
temperature probe adaptors can cause a loss of temperature monitoring which can
cause a delay in care when an alarm is missed.
VOLUME OF PRODUCT IN
COMMERCE 2,635
devices
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Universal SlingBar 350 Product Number: 3156074 Used with the:
Viking XS, Viking S, Viking M, Viking L Patient Lifts,
b) Universal SlingBar 450 Product Number: 3156075 Used
with the: Viking XS, Viking S, Viking M, Viking L Patient
Lifts,
c) Universal SlingBar 600 Product Number:
3156076 Used with the: Viking XS, Viking S, Viking M,
Viking L Patient Lifts,
d) Universal SlingBar 350 with
Quick-release Hook Product Number: 3156084 Used in
combination with all lifts from Liko, i.e. mobile lifts and overhead lifts,
e) Universal SlingBar 450 with
Quick-release Hook Product Number: 3156085 Used in
combination with all lifts from Liko, i.e. mobile lifts and overhead lifts, R
f) Universal SlingBar 600 with
Quick-release Hook Product Number: 3156086 Used in
combination with all lifts from Liko, i.e. mobile lifts and overhead lifts,
CODE
Serial
numbers: 1200101-1245680, 121204-121499, 12222407-12225241
RECALLING
FIRM/MANUFACTURER Liko AB, Lulea, Sweden,
REASON
A
component securing the Universal SlingBar to the patient lift, may experience a
nut unthreading resulting in the sling bar detaching from the lift causing the
patient to fall.
VOLUME OF PRODUCT IN COMMERCE 4,000
units
DISTRIBUTION Nationwide
PRODUCT Medline RF Detect Sterile X-Ray Detectable USP Type VII Gauze; 8" x
4", 12-ply, 100% cotton sponges, 10 sponges per pack, 80 packs per case; Made in
China; reorder: NON21432RF,
CODE
Lot Numbers: CM130002052, CM130002062, CM130002075,
CM130002068, CM130002079, CM130002110
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medline Industries Inc.,
Mundelein, IL,
Manufacturer: Allmed
Medical Products Co Ltd, Shanzen, China.
REASON There is the potential for the RF ID tag to
separate from the retaining pouch.
VOLUME OF PRODUCT IN
COMMERCE 295 cases
DISTRIBUTION CA, IN, MO,
OH, OK, PA, TX, and WA
PRODUCT Ventlab-assembled Anesthesia breathing bags. The recall involves
(NC Facility): a) Part #720057B (3 Liter bags); b) Part #720058B (2 Liter bags);
and c) Part #720059B (1 Liter); (China Facility): a) Part #720057B; b) Part
#720058B; and c) Part #720059B, latex free bags used with Medline anesthesia
circuit kits. The bags are sold in bulk,
CODE
(North Carolina Facility):
a) Lot
#63069, 64872, 65226, 66781, 67068, 67068;
b) Lot#63660, 64877, 65225,
68752;
c) Lot#63661, 64878, 65227;
(China Facility): a) Lot #3B0001,
3B0002, 3B0005, 3B0004, 3B0005;
b) Lot #1B0001, 1B0002,
1B0003; c) Lot #2B0002
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ventlab Corp.,
Mocksville, NC,
Manufacturer:
Amerasia Industries, Guangdong, China. REASON During setup and potentially during procedures,
the breathing bag can become separated from the taped bushing that is part of
the breathing bag assembly.
VOLUME OF PRODUCT IN
COMMERCE 571,500
units
DISTRIBUTION IL
PRODUCT
a) Evita 2 dura Critical Care Ventilator. Continuous (Respirator).
Catalog number 8411800. Products recalled had the CO2
Carrier Printed Circuit Board (PCB) part
number 8306611
replaced between January 2005 and May 2008,
b) Evita 4 Critical Care Ventilator.
Continuous (Respirator); Catalog number 8411900,
c) Evita XL Critical Care Ventilator. Continuous (Respirator).
Catalog number 8414900,
CODE Serial number: CO2 Carrier PCBs have a prefix of
ARW, ARX, or ARY
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Draeger Medical, Inc., Telford, PA,
Manufacturer: Draeger Aerospace Gmbh, Lubeck, Germany.
REASON
Audible power failure alarm was not
enunciated at the required volume.
VOLUME OF PRODUCT IN
COMMERCE 83 units
DISTRIBUTION AZ, CA, CO,
FL, GA, IL, KY, MA, MI, MS, NJ, NY, PA, TN, TX, UT and
WA
PRODUCT Propper short
gas-chex EO sterilization indicators, 250 strips per
box, Reorder No. 269001,
CODE Lot
numbers: 6081, 6043, 6021, 7042, and 7013
RECALLING
FIRM/MANUFACTURER Propper Manufacturing Co., Inc., Long Island City, NY
REASON
A production specification discrepancy
may cause the indicators to show an inaccurate result.
VOLUME OF
PRODUCT IN COMMERCE 1,757 cases (7,030
boxes)
DISTRIBUTION Nationwide
PRODUCT
a) Cotton-Leung Biliary Stent., CLSO-10-5, Stent Diameter: 10 FR,
Stent Length: 5cm, Disposable-Single use only, Rx Only.
Used to train obstructed biliary ducts,
b) Cotton-Leung Biliary Stent. CLSO-10-10, Stent Length:10cm in
length, Disposable- Single use only, Rx Only. Used to
train obstructed biliary ducts,
CODE
a) Lot number: W512494;
b) Lot
number: W2512492
RECALLING FIRM/MANUFACTURER Cook Endoscopy, Winston-Salem, NC,
REASON
The product
packaging label indicates the stent is 5cm, but the actual stent inside the
packaging measures 10cm.
VOLUME OF PRODUCT IN COMMERCE 40
units
DISTRIBUTION MO, NC, NV, TX, UT and
India
PRODUCT Permanent Pacing Lead (Catalog #: 03332, 03334, 03337, 03107,
03116, 03108, 03109, 05756, 53420, 05765, 03634, 03633, and 05747); Model #:
PY244RU, PY252RU, PY258RU, REFINO58RU, REFINO 52RJU, REFINO 44RJU, REFINO48RJU,
BIS/IS-15, BIS/BIS-17, VKU-10V, MP52PV, MP40PV, C/IS-10; Pacing and sensing of
the ventricle and/or atrium of the heart in conjunction with a compatible,
implantable pulse generator/pacemaker,
CODE Lot numbers: 02-01502, 02-01812,
02-01436, 02-01440, 02-02016, and 02-01945
RECALLING
FIRM/MANUFACTURER Oscor, Inc., Palm Harbor, FL,
REASON
The O-rings are over tolerance making it
hard to connect the leads to the pacemaker.
VOLUME OF PRODUCT IN
COMMERCE 783
units
DISTRIBUTION Nationwide
PRODUCT ZOLL OneStep Multi-Function Electrode; Adult Complete Part #:
8900-0214-01. The electrodes are indicated for the following clinical
applications: Defibrillation, Cardioversion, Noninvasive pacing, and
Electrocardiograph monitoring,
CODE Lot numbers: 2108 and
2208
RECALLING FIRM/MANUFACTURER BioDetek, Inc.,
Pawtucket, RI,
REASON Multi-function electrode programmed as a
Pediatric instead of Adult.
VOLUME OF PRODUCT IN
COMMERCE 400
units
DISTRIBUTION MA
PRODUCT Radiation Reduction Gloves, sterile, Latex-free, Catalog No.
SSR1-7.5, SSR1-8.0,
CODE Lot
numbers: W0806178, W0806179, and W0806177
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Integra Pain Management, Salt Lake
City, UT,
Manufacturer: Protech
Leaded Eyewear, Palm Beach Gardens, FL.
REASON Radiation reduction gloves were labeled
as "Latex-free", but contain natural rubber latex.
VOLUME OF PRODUCT
IN COMMERCE 140 boxes
DISTRIBUTION AL, CA,
FL, LA, NY, SC, TX
PRODUCT
a) PLV-100 Portable Lifecare Ventilator Life support ventilation.
The device is intended to mechanically control or assist
patient breathing by delivering a predetermined
percentage of oxygen in the breathing gas. Life support ventilation.
Model/Catalog number PLV-100,
b) Power Board Kit for use with the PLV-100 Portable Lifecare
repairs. Model/Catalog number PLV-100. Circuit board part
numbers 1034786 version 5 or 1036038 version 3
CODE Version 3 and Version 5
RECALLING FIRM/MANUFACTURER Respironics, Inc.,
Murrysville, PA,
REASON Certain PLV-100 ventilators may not
trigger a signal to activate third-party remote alarms or nurse call systems
upon device failure.
VOLUME OF PRODUCT IN COMMERCE 197
units
DISTRIBUTION NC, IL, NJ, MO, TX , OH, IA, OK,
Japan, Denmark, Korea, Australia, Finland, Canada, Argentina, New Zealand, Hong
Kong, and India
PRODUCT Rejuvenate Broach Catalog No: 1601-1005, 1601-1006, 1601-1007,
1601-1008, 1601-1009, 1601-1010. Contours the proximal femur to the geometry of
the stem to provide a complimentary fit of the stem to the bone. The broaches
are designed with a series of teeth that are intended to seat against highly
densified cancellous bone for the interference press-fit in the uncemented
application, CODE All lot
codes
RECALLING FIRM/MANUFACTURER Stryker Howmedica
Osteonics, Corp., Mahwah, NJ
REASON Rejuvenate Broach system was
designed in a manner that may result in the potential for a medical calcar
fracture.
VOLUME OF PRODUCT IN COMMERCE 78
units
DISTRIBUTION Nationwide
PRODUCT FloSeal Endoscopic Applicator , Product Code 1500181. The product
is indicated in surgical procedures (other than in neurosurgical, opthalmic, and
urological) as an adjunct to hemostasis when control of bleeding by ligature or
conventional procedures is ineffective or impractical. Product Code: 1500181,
CODE
Lot Numbers: 05H035, 06N005,
06N017, 07A043, 07B044, 07E025, 07F010, 07G031, 07H016, 07J029, 07K034, 07N007,
088048, 08C020, 08D017, 08D053, and 08E041
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Bioscience, Westlake
Village, CA, Manufacturer: Baxter
Healthcare Corp., Medication Delivery Division, Irvine, CA.
REASON
The recall is being conducted
as a precautionary measure due to potential discoloration of the FloSeal
material noted in six (6) non-medical complaints during delivery by the
Endoscopic Applicator.
VOLUME OF PRODUCT IN
COMMERCE 10,345 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
a) HACH SteriChek Sensitive Total Chloramines and Residual Chlorine
Reagent Strips, Tests for feed water and rinse water down
to 0.1 ppm (mg/l), packaged in bottles
containing 100
strips each, 5 bottles per kit, Part #811909. The firm name on the label is Hach, Ames, IA. The product is used in measuring
for low levels of total chlorine (including chloramines
and free chlorine) in feed water used to prepare
dialysate,
b) HACH SteriChek Sensitive Total Chlorine
Reagent Strips, Tests for water and rinse water down to
0.1 mg/l (ppm), packaged 1/100-strip btl. per carton, 12 cartons per
shipping case, Product #821972. The product is used in
measuring for low levels of total chlorine (including
chloramines and free chlorine) in feed water used to prepare
dialysate, ;
c) RPC E-Z Chek Sensitive Total
Chlorine and Chloramines Test Strips, Tests Water for
Total Chlorine & Chloramines down to 0.1 ppm (mg/l), packaged in a
1/100-strip bottle, 60 bottles per tray, 5 trays per
shipping case, Product code K100-0106 (HACH Part
#812004). The product is used in measuring for low levels of total chlorine (including chloramines and free chlorine) in feed water
used to prepare dialysate,
d)
HACH SteriChek Sensitive Total Chloramines and Residual Chlorine Reagent Strips, tests for feed water and rinse water down to 0.1 ppm
(mg/l), packaged in bags
containing 1/100-strip bottle,
one medicine cup, and one insert. Each bag is sealed and
labeled "812144 SteriChek Sensitive, Bagged," 56 bags per cardboard tray,
5 trays per shipping case. Product code 812144 The
product is used in measuring for low levels of total
chlorine (including chloramines and free chlorine) in feed
water used to prepare dialysate,
CODE
a) Lot numbers 6248, 6254, 6264, 6266,
6280, 6305, 6312, 6317, 6334, 6347, 6353, 6355, 7002,
7012, 7015, 7031, 7044, 7066, 7072, 7073, 7085, 7094, 7121, 7131, 7049, 7150, 7152, 7163, 7167, 7177, 7295, 7296, 7309,
7325, 7340, 7352, 7355, 8028, 8045, 8066, 8084, 8094,
8106, 8123, 8144, 8155, 8166, 8171, 7179, 7200,
7220,
7236, 7239, 7250, and 7282;
b) Lot numbers 6233, 6278, 6313, 6326, 6341,
7039, 7071, 7092, 7127, 7171, 7193, 7213, 7253, 7255,
7302, 7339, 7339, 8008, 8029, 8063, 8081, 8096, 8125, and 8150;
c) Lot
numbers 6265, 6310, 7008, 7054, 7086, 7130, 7183, 7201, 7234, 7284, 7313, 8010, 8030, 8057, 8078, 8108, and 8160;
d) Lot
numbers 7264, 7267, 7268, 7270, 7344, 7360, 7362, 8085, 8128, 8152, 8164, and 8173
RECALLING
FIRM/MANUFACTURER Hach Co., Ames, IA,
REASON
Inconsistencies in total chlorine and
free chlorine levels may result in providing inaccurate false positive or false
negative results.
VOLUME OF PRODUCT IN COMMERCE 163,090
bottles
DISTRIBUTION Nationwide, Canada and
Denmark
PRODUCT
a) GE Innova 3100 / 3100 IQ, Cardiovascular Imaging System, (The
system consists of an a monoplane positioner, a vascular
or cardiac table, an X-ray system and a digital
detector)
The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography diagnostic and
interventional procedures and
optionally, rotational
imaging procedures. It is also intended for generating
fluoroscopic images of human anatomy for cardiology, diagnostic and
interventional procedures,
b) GE
Innova 2100IQ Versatile Cardiac and Vascular Imaging System, (The system consists of an a monoplane
positioner, a vascular or
cardiac table, an X-ray system
and a digital detector)
The product is indicated for use in generating fluoroscopic images of human anatomy for vascular angiography
diagnostic and interventional procedures and optionally,
rotational imaging procedures. It is also intended for
generating fluoroscopic images of human anatomy for cardiology, diagnostic and interventional procedures,
c) GE
Innova 4100 / 4100 IQ. , (The system consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital
detector) The product is indicated for use in generating
fluoroscopic images of human anatomy for vascular
angiography diagnostic and interventional procedures and optionally, rotational imaging procedures. It is also intended for generating
fluoroscopic images of human anatomy for cardiology,
diagnostic and interventional procedures,
d) Advantx-E The Advantx imaging system is intended to be used
for general purpose diagnostic angiographic fluoroscopy
and radiographic studies,
e) Innova 2121-1Q/3131-1Q Biplane Cardiovascular Imaging System. The Innova Biplane systems are the first and only digital flat panel
biplane systems with a full sized lateral plane to cover
lateral anatomy without requiring multiple contrast
injections and radiation exposures. The product is indicated for use in
generating fluoroscopic images of human anatomy for
diagnostic and interventional cardiac angiography
procedures. These systems can be operated in a mobile or fixed site environment,
f) Innova
2000 The principle system components include a C-arm, image acquisition, processing and archiving capabilities. The product is
indicated for use in generating fluoroscopic images of
human anatomy for diagnostic and interventional cardiac
angiography procedures. These systems can be operated in a mobile or fixed site environment,
CODE
a) Serial Numbers: 00000536885BU7 00000524151BU8
00000807/61010 123100037 1203100026 1203100029 00000507807BU6 00000520244BU5
00000460530BU9 00000469400bu6 00000452842BU8 00000112420VE5 00000469349BU5
00000469380BU0 00000307/50876 00000524122BU9 00000453185BU1 00000460590BU3
00000105/30212 9110080 00000469377BU6 00000504/10092 00000704/20116
00000507774BU8 00000493795BU9 00000307/50891 00000507773BU0 00000460632BU3
00000112399VE1 00000407/50915 00000483688BU8 704120117 00000536842BU8
00000112423VE9 00001004-20153 00000524162BU5 00000536835BU2 00000048698BU7
00000507811BU8 00000807/61019 00000507/50956 00001204/30190 00000507817BU5
00000469368BU5 00001204/30187 00000452891BU5 00000452866BU7 00000707/60982
00001204/30191 00000493809BU8 00000112407VE2 00000112409VE8 00000499188BU1
00000499133BU7 00000507792BU0 00000536845BU1 00000469343BU8 00000524118BU7
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00000520268BU4 00000307/50878 00000407/50910 00000469359BU4 00000112427VE0
00000469354BU5 00000493804BU9 00000604-10104 00000507814BU2 00000453182BU8
00000307/50883 00000460580BU4 00000453184BU4 0000M04/200013 304110059
00000707/60979 00000507770BU6 00000499138BU6 00000307/50900 00000483685BU4
00000520280BU9 00000499152BU7 00000460557BU2 00000469410NU5 00000307/50872
00000536892BU3 00000112414VE8 00000460621BU6 00000520265BU0 00000524152BU6
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00000507804BU3 1204930184 00000907/60185 00001004/20148 00000469352BU9
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00000452820BU4 00000507831BU6 00000466729BU1 00000466708BU5 00000499163BU4
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00000536853BU5 00000507782BU1 00000460547BU3 00000507790BU4 00000460574BU7
00000112411VE4 00000407/50919 00000507/50958 00000524149BU2 00000907/61026
00000112442VE9 00000407/50166 00000108/61118 00000460548BU1 00000536919BU4
00000707/60997 00000707/50973 00000520260BU1 00000453143BU0 00000469301BU6
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00000453171BU1 00000520297BU3 00000483690BU4 00000536841BU0 00000469254BU7
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00000452881BU6 00001107/61056 00000112451VE0 00000524142BU7 00000307/50867
00000507/50933 00000507/50949 00000469376BU8 00000604/10089 00000520256BU9
00000469374BU3 00000407/50917 00000507/50934 00000507/50955 00000520284BU1
00000469229BU9 00000452802BU2 00000466692BU1 00000466726BU7 00000707/50612
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00000304/20127 00000499137BU8 00000524132BU8 00000407/50588 00000469270BU3
00000507/50945 and 00000507/50946;
b) Serial Numbers: 00000466713BU5
00000466705BU1 00000524119BU5 00000536916BU0 00000112428VE8 00000460509BU3
00000507823BU3 00000460516BU8 00000469271BU1 00000460505BU1 00000460528BU3
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00000520248BU6 00000460549BU9 00000307/50896 00000469345BU3 00000112416VE3
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00000469344BU6 00000452845BU1 00000112418VE9 00000469335BU4 00000112431VE2
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00000112419VE7 00000469370BU1 00000469358BU6 00000493805BU6 00000524117BU9
00000460520BU0 00000466675BU6 00000460511BU9 00000483699BU5 00000536839BU4
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00000507/50938 00000524147BU6 00000452812BU1 00000460569BU7 00000452921BU0
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00000460597BU8 00000407/50916 40372 00000452901BU2 404110077 00000466684BU8
00000536876BU6 00000536850BU1 00000536913BU7 00000466756BU4 00000469269BU5
00000507813BU4 00000112405VE6 00000112410VE6 00000460576BU2 00000466685BU5
00000466714BU3 00000466671BU5 00000536836BU0 00000108/60209 00000108/61090
00000707/60992 00000452836BU0 00001207/61063 00000907/60631 00000460585BU3
00000460563BU0 00000536904BU6 00000536922BU8 00000469372BU7 00000112447VE8
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00000307/50889 00000469284BU4 00000520253BU6 00000607/50604 00000507839BU9
00000507/50952 00000469360BU2 and 00000307/50909;
c) Serial Numbers:
00000469348BU7 00000536877BU4 404110063 00000452883BU2 00000504/10096
00000460596BU0 00000469365BU1 00000704/20115 704120114 00000536912BU9
00000460572BU1 00000052416BU0 00000460630BU7 00000307/50895 120310008
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1203100034 1003 00000453165BU3 00000469337BU0 404110079 00000469264BU6
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00001004/20145 00000404/10086 104100047 304110017 00000GD60U6-GE 00000904/20130
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504110085 00000112397VE5 00000307/50868 00000507832BU4 00000307/50877
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00000807/60623;
d) Serial Numbers: 00001104/20163 00000453208BU1
00000604/20009 00000452923BU6 00001104/20026 1003000011 106100046 304110016
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00000466721BU8 00000453149BU7 and 00000453216BU4;
e) Serial Numbers:
00000483707BU6 00000452932BU7 00000208/00036 00000452935BU0 00001107/00021
00000907/00004 00000208/00039 00001107/00016 00001007/00009 00000707/00001
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S0000607/50962 5126893 00000108/00031 00000108/00032 00000108/61100
00000108/61112 00000112430VE4 00000112435VE3 00000112444VE5 00000112455VE1
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00000452913BU7 00000499177BU4 00000807/50178 00001107/00020 00000507/50925 and
00000536847BU7;
f) Serial Numbers: 00000108/61094 1003100013
0000010031000L 00000452818BU8 00000704/20108 1103100019 1103100019
00000404/10070 104100053 104100051 104100057 00000452834BU5 1104120128
00000452889BU9 00000452890BU7 00000524134BU4 00001104/20167 909110081 1103100025
00000452863BU4 000005041A0050 0000904/201135 00000405/40184 00001104/20157
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1003100009 00000453141BU4 00001204/30186 00001104/20172 00000466711BU9
00000704/20102 00000469228BU1 1103100017 00000707/50172 30177 100300002
110300023 1103100026 00001003/00002 00001103/00023 00000452894BU9 609110902
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104100050 00000707/60998 00000469313BU1 00000307/50908 00000807/61002
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1203100025 00000104/00052 00000452839BU4 00000536863BU4 00000460617BU4
00000452815BU4 00000452838BU6 1203100041 304110072 24110061 204110061
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00000104-00014 00001004/20150 00000604/20095 00000604/20098 00000704/20111
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00000604/10087 00000112450VE2 00000460543BU2 00001003/00008 00000452816BU2
00000499172BU5 and 00000499169BU1
RECALLING
FIRM/MANUFACTURER
Recalling Firm: GE Healthcare, Waukesha, WI,
Manufacturer: GE Medical Systems,
SCS, Buc Cedex,
France.
REASON GE
Healthcare has become aware of 2 potential conditions that could occur with the
MAVIG GD Monitor Suspension that is used with Advantx-E, Innova 2000, 21000IQ,
3100/3100IQ, 4100/4100IQ and 2121 IQ/3131IQ cardiovascular systems. The two
conditions include 1). Due to insufficient securing of the connecting elements,
the LCD vertical monitor support may disengage from its arm and fall on the
table or into the table vicinity and 2). Only Service personnel working inside
the suspension may potentially experience this condition: Incorrect cable
routing on side, inside the LCD monitor suspension arm, may cause the ECG
monitor power cable to be damaged, potentially resulting in a short circuit that
could cause sparks. The potential risk of an electrical shock affects only
Service personnel working inside the Mavig suspension without first tuning off
both power supplies of the X-ray equipment and of the ECG
monitor.
VOLUME OF PRODUCT IN COMMERCE 1,628
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) 10ml Control Syringe, REF/CAT No.: CCX011 Version A, Sterile EO.
The product is used for injections of contrast medium
during Coronary or Peripheral Angiography and
Angioplasty,
b) 12ml Control Syringe, REF/CAT No.:
CCS601 Version B, Sterile R. The product is used for
injections of contrast medium during Coronary or Peripheral Angiography and Angioplasty,
c) 12ml Control
Syringe / Smart Tip, REF/CAT No.: ST601, Sterile EO. The product is used for injections of contrast medium during Coronary or
Peripheral Angiography and Angioplasty,
CODE
a) Lot Number: F621152;
b) Lot
Number: F620653;
c) Lot Number: F620922
RECALLING
FIRM/MANUFACTURER Merit Medical Systems, Inc., South
Jordan, UT,
REASON Control Syringes may be non-sterile due
to holes in the packaging.
VOLUME OF PRODUCT IN
COMMERCE 1,298 units
DISTRIBUTION CA, FL, GA,
ID, IL, IN, KS, LA, MO, MT, OH, PA, TN, WA and
Japan
PRODUCT BD
60 ml Syringe, Luer-Lok Tip Sterile; Cases: 160 (4 x 40) Shelf Carton: 40 BD;
Made in USA. Syringes for use in aspiration and injection of medications.
Reorder Number: 309653,
CODE
Lot
numbers beginning with the numbers 5, 6, or 7 and also the following lot
numbers. 8010954, 8014571, 8031115, 8031117, 8031119, 8031124, 8031133, 8038154,
8038158, 8045564, 8045567, 8058890, 8058896, 8058898, 8058900, 8058902, 8072401,
8072409, 8072414, 8072419, 8079645, and 8079656
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson & Co.,
Franklin Lakes, NJ,
Manufacturer: Becton
Dickinson & Co., Columbus, NB. REASON Becton Dickinson identified the presence
of open seals during an internal inspection process.
VOLUME OF
PRODUCT IN COMMERCE 1,246
lots
DISTRIBUTION Nationwide
PRODUCT
a) VERTIER Surgical Table, Catalog #0788-100-000 (Standard
table); Is an AC powered, general purpose, mobile
surgical table with electro-hydraulically controlled
movements which are part of a control feedback system,
b) VERTIER Surgical Table, Catalog #0788-100-001 (Standard table
with 5th wheel); Is an AC powered, general purpose, mobile
surgical table with electro-hydraulically controlled
movements which are part of a control feedback system,
c) VERTIER Surgical Table, Catalog
#0788-100-000S (SIDNE-enabled standard table); Is an AC
powered, general purpose, mobile surgical table with electro-hydraulically controlled movements which are part of a control feedback
system,
d) VERTIER Surgical
Table, Catalog #0788-100-001S (SIDNE-enabled standard table with 5th wheel); Is an AC powered, general purpose,
mobile surgical table with electro-hydraulically
controlled movements which are part of a control feedback
system,
CODE
All lot codes/serial
numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Communications Corp., Flower Mound, TX,
Manufacturer: Merivaara Corp.,
Lahti, Finland.
REASON Hydraulic lines responsible for
tilting the surgical table have the potential to be severed when articulating
table to its lowest position, possibly resulting in the unexpected and rapid
movement of the table.
VOLUME OF PRODUCT IN COMMERCE 90
units
DISTRIBUTION AR, CA, FL, GA, ID, IL, IN, KS, KY,
MN, MO, ND, NJ, NY, OH, OK, OR, SD, TX, UT, VA and Washington DC
PRODUCT Xpect Giardia/Cryptosporidium Kit, Ref 24050520, 20 tests per kit, For In Vitro
Diagnostic Use. A rapid test for the direct qualitative detection of Giardia and
Cryptosporidium antigens in fecal specimens,
CODE
Lot numbers 597374, Exp. 2008.10.08;
607636, Exp. 2008.11.06; 615970, Exp. 2008.12.02; 615971, Exp. 2008.12.02;
621187, Exp. 2008.12.02; 622617, Exp. 2009.04.02; 624618, Exp. 2009.01.02;
635553, Exp. 2009.04.17; 635554, Exp. 2009.04.24; 640609, Exp. 2009.05.01;
654829, Exp. 2009.05.30; and 658878, Exp. 2009.05.30
RECALLING
FIRM/MANUFACTURER Remel, Inc., Lenexa, KA,
REASON Faint grey
test lines for Cryptosporidium may be visible which may be interpreted as false
positive.
VOLUME OF PRODUCT IN COMMERCE 3,974
kits
DISTRIBUTION Nationwide, Canada and
U.K
PRODUCT BD
Visitec Disposable Instrument (plastic handle) Capsulorhexis Forceps, Sterile
Ref: 581440, Used during cataract and other ophthalmic surgery procedures to
grasp lens capsule,
CODE Lot Number:
8067450 Exp. Date: March 2011
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Becton Dickinson and Co.,
Waltham, MA,
Manufacturer: Becton Dickinson
Ophthalmic Systems, Warwickshire, UK.
REASON Metal particulates
present.
VOLUME OF PRODUCT IN COMMERCE 260
units
DISTRIBUTION CA, IL, KY, MS, PA, and TX
WEEK ENDING OCTOBER 25
PRODUCT Ultraview
Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital
Telemetry system provides continuous electrocardiographic (ECG) monitoring to
detect ST segment changes, abnormal cardiac rhythms, including a systole,
ventricular fibrillation and ventricular tachycardia,
CODE
Serial numbers: 1341-000517,
1341-000518, 1341-000519, 1341-000521, 1341-000524, 1341-000525, 1341-000526,
1341-000527, 1341-000528, 1341-000529, 1341-000530, 1341-000531, 1341-000532,
1341-000533, 1341-000534, 1341-000535, 1341-000536, 1341-000537, 1341-000538,
1341-000539, 1341-000540, 1341-000541, 1341-000543, 1341-000544, 1341-000545,
1341-000546, 1341-000547, 1341-000548, 1341-000549, 1341-000550, 1341-000551,
1341-000552, 1341-000553, 1341-000556, 1341-000557, 1341-000558, 1341-000559,
1341-000560, 1341-000561, 1341-000562, 1341-000563, 1341-000564, 1341-000565,
1341-000566, 1341-000570, 1341-000571, 1341-000572, 1341-000573, 1341-000574,
1341-000575, 1341-000576, 1341-000577, 1341-000578, 1341-000579, 1341-000580,
1341-000582, 1341-000583, 1341-000584, 1341-000585, 1341-000586, 1341-000587,
1341-000589, 1341-000590, 1341-000591, 1341-000592, 1341-000593, 1341-000594,
1341-000595, 1341-000596, 1341-000597, 1341-000598, 1341-000599, 1341-000600,
1341-000601, 1341-000602, 1341-000603, 1341-000604, 1341-000605, 1341-000606,
1341-000607, 1341-000611, 1341-000612, 1341-000613, 1341-000614, 1341-000615,
1341-000616, 1341-000617, 1341-000618, 1341-000619, 1341-000620, 1341-000621,
1341-000622, 1341-000623, 1341-000624, 1341-000625, 1341-000626, 1341-000627,
1341-000628, 1341-000630, 1341-000631, 1341-000632, 1341-000633, 1341-000634,
1341-000635, 1341-000636, 1341-000637, 1341-000638, 1341-000639, 1341-000640,
1341-000641, 1341-000642, 1341-000643, 1341-001239, 1341-001240, 1341-000245,
1341-000246, 1341-000247, 1341-000248, 1341-000250, 1341-000251, 1341-000252,
1341-000253, 1341-000254, 1341-000255, 1341-000256, 1341-000257, 1341-000508,
1341-000509, 1341-000510, 1341-000511, 1341-000512, 1341-000513, 1341-000514,
1341-000699, 1341-000700, 1341-001029, 1341-001033, 1341-001034, 1341-001035,
1341-001037, 1341-001038, 1341-001039, 1341-001040, 1341-001041, 1341-001042,
1341-001043, 1341-001045, 1341-001046, 1341-001047, 1341-001048, 1341-001049,
1341-001050, 1341-001051, 1341-001053, 1341-001055, 1341-001056, 1341-001057,
1341-001058, 1341-001059, 1341-001095, 1341-001242, 1341-001244, 1341-001390,
1341-001391, 1341-001393, 1341-001394, 1341-001395, 1341-001396, 1341-001397,
1341-001398, 1341-001399, 1341-001400, 1341-001401, 1341-001428, 1341-001429,
1341-001446, 1341-001448, 1341-001450, 1341-001452, 1341-001454, 1341-001455,
1341-001456, 1341-001457, 1341-001636, 1341-001637, 1341-001638, 1341-001639,
1341-001640, 1341-001749, 1341-001750, 1341-001933, 1341-001934, 1341-001935,
1341-001936, 1341-001937, 1341-001938, 1341-001952, 1341-001953, 1341-001954,
1341-001955, 1341-001956, 1341-001957, 1341-001958, 1341-001959, 1341-001960,
1341-001940, 1341-001941, 1341-001942, 1341-001943, 1341-001944, 1341-001945,
1341-001946, 1341-001947, 1341-001948, 1341-001949, 1341-001950, 1341-001951,
1341-001234, 1341-001235, 1341-001236, 1341-001237, 1341-001372, 1341-001373,
1341-001374, 1341-001375, 1341-001376, 1341-001377, 1341-000098, 1341-000099,
1341-000100, 1341-000101, 1341-000102, 1341-000103, 1341-000104, 1341-000105,
1341-000106, 1341-000107, 1341-000108, 1341-000109, 1341-000110, 1341-000111,
1341-000112, 1341-000113, 1341-000114, 1341-000115, 1341-000234, 1341-000235,
1341-000236, 1341-000237, 1341-000238, 1341-000239, 1341-000240, 1341-000241,
1341-000242, 1341-000243, 1341-000244, 1341-000260, 1341-000261, 1341-000262,
1341-000263, 1341-000264, 1341-000265, 1341-000266, 1341-000427, 1341-000428,
1341-000429, 1341-000430, 1341-000431, 1341-000432, 1341-000433, 1341-000434,
1341-000435, 1341-000436, 1341-000437, 1341-000438, 1341-000439, 1341-000440,
1341-000441, 1341-000442, 1341-000443, 1341-000444, 1341-000445, 1341-000446,
1341-000830, 1341-000831, 1341-000832, 1341-000833, 1341-000834, 1341-000835,
1341-000836, 1341-000837, 1341-000838, 1341-000839, 1341-000840, 1341-000841,
1341-000842, 1341-000843, 1341-000844, 1341-000845, 1341-000846, 1341-000847,
1341-000848, 1341-000849, 1341-000850, 1341-000851, 1341-000852, 1341-000853,
1341-000854, 1341-000855, 1341-000856, 1341-000857, 1341-000858, 1341-000859,
1341-000860, 1341-000861, 1341-000862, 1341-000863, 1341-000864, 1341-000865,
1341-000866, 1341-000867, 1341-000868, 1341-000869, 1341-000870, 1341-000871,
1341-000872, 1341-000873, 1341-000874, 1341-000875, 1341-000876, 1341-000877,
1341-000878, 1341-000879, 1341-000880, 1341-000881, 1341-000882, 1341-000883,
1341-000884, 1341-000885, 1341-000886, 1341-000887, 1341-000888, 1341-000889,
1341-000890, 1341-000891, 1341-000892, 1341-000893, 1341-000894, 1341-000895,
1341-000896, 1341-000897, 1341-000898, 1341-000899, 1341-000900, 1341-000901,
1341-000902, 1341-000903, 1341-000904, 1341-000905, 1341-000906, 1341-000907,
1341-000908, 1341-000909, 1341-000910, 1341-000911, 1341-000912, 1341-000913,
1341-000914, 1341-000915, 1341-000916, 1341-000917, 1341-000918, 1341-000919,
1341-000920, 1341-000921, 1341-000922, 1341-000923, 1341-000924, 1341-001145,
1341-001146, 1341-001147, 1341-001148, 1341-001149, 1341-001150, 1341-001151,
1341-001649, 1341-001096, 1341-001097, 1341-001098, 1341-001099, 1341-001100,
1341-001101, 1341-001102, 1341-001103, 1341-001104, 1341-001105, 1341-001106,
1341-001107, 1341-001108, 1341-001109, 1341-001110, 1341-001111, 1341-001112,
1341-001113, 1341-001114, 1341-001115, 1341-001116, 1341-001117, 1341-001118,
1341-001119, 1341-001120, 1341-001121, 1341-001122, 1341-001123, 1341-001124,
1341-001125, 1341-001126, 1341-001127, 1341-001128, 1341-001129, 1341-001130,
1341-001131, 1341-001132, 1341-001133, 1341-001134, 1341-001135, 1341-001136,
1341-001137, 1341-001138, 1341-001139, 1341-001202, 1341-001203, 1341-001204,
1341-001205, 1341-001206, 1341-001207, 1341-001208, 1341-001209, 1341-001210,
1341-001211, 1341-001212, 1341-001213, 1341-001214, 1341-001215, 1341-001216,
1341-001249, 1341-001250, 1341-001251, 1341-001252, 1341-001253, 1341-001254,
1341-001255, 1341-001256, 1341-001257, 1341-001258, 1341-001259, 1341-001260,
1341-001261, 1341-001262, 1341-001263, 1341-001264, 1341-001265, 1341-001266,
1341-001267, 1341-001268, 1341-001269, 1341-001270, 1341-001271, 1341-001272,
1341-001273, 1341-001274, 1341-001276, 1341-001277, 1341-001278, 1341-001656,
1341-001657, 1341-001658, 1341-001659, 1341-001660, 1341-001661, 1341-001662,
1341-001663, 1341-001692, 1341-002117, 1341-002162, 1341-000320, 1341-000321,
1341-000322, 1341-000323, 1341-000324, 1341-000325, 1341-000326, 1341-000327,
1341-000328, 1341-000329, 1341-000330, 1341-000331, 1341-000332, 1341-000333,
1341-000334, 1341-000335, 1341-000336, 1341-000337, 1341-000338, 1341-000339,
1341-000340, 1341-000341, 1341-000342, 1341-000343, 1341-000344, 1341-000345,
1341-000346, 1341-000347, 1341-000348, 1341-000349, 1341-000350, 1341-000351,
1341-000352, 1341-000353, 1341-000354, 1341-000355, 1341-000356, 1341-000357,
1341-000358, 1341-000359, 1341-000360, 1341-000361, 1341-000362, 1341-000363,
1341-000364, 1341-000365, 1341-000366, 1341-000367, 1341-000368, 1341-000369,
1341-000370, 1341-000371, 1341-000372, 1341-000373, 1341-000374, 1341-000375,
1341-000376, 1341-000377, 1341-001699, 1341-001700, 1341-001701, 1341-001702,
1341-001703, 1341-001704, 1341-001705, 1341-001706, 1341-001707, 1341-001708,
1341-001709, 1341-001710, 1341-001711, 1341-001712, 1341-001713, 1341-001714,
1341-001715, 1341-001716, 1341-001717, 1341-001718, 1341-001719, 1341-001720,
1341-001721, 1341-001722, 1341-001723, 1341-001724, 1341-001725, 1341-001726,
1341-001727, 1341-001728, 1341-001729, 1341-001730, 1341-001731, 1341-001732,
1341-001733, 1341-001734, 1341-001735, 1341-001736, 1341-001737, 1341-001738,
1341-001739, 1341-001740, 1341-001741, 1341-001742, 1341-001743, 1341-001744,
1341-001745, 1341-001746, 1341-001886, 1341-001887, 1341-001939, 1341-002143,
1341-002144, 1341-002145, 1341-002146, 1341-002147, 1341-002148, 1341-002149,
1341-002150, 1341-002151, 1341-002152, 1341-002153, 1341-002154, 1341-002155,
1341-002156, 1341-002157, 1341-002158, 1341-001758, 1341-001759, 1341-001760,
1341-001761, 1341-001641, 1341-001642, 1341-001643, 1341-001644, 1341-001645,
1341-001646, 1341-001647, 1341-001648, 1341-001083, 1341-001084, 1341-001085,
1341-001086, 1341-001087, 1341-001088, 1341-000569, 1341-000567, 1341-001217,
1341-000379, 1341-000380, 1341-000382, 1341-000383, 1341-000384, 1341-000385,
1341-000388, 1341-000389, 1341-000390, 1341-000393, 1341-000396, 1341-000398,
1341-000399, 1341-000403, 1341-000404, 1341-000405, 1341-000406, 1341-000407,
1341-000408, 1341-000929, 1341-000930, 1341-000931, 1341-000932, 1341-000933,
1341-000934, 1341-000935, 1341-000936, 1341-000937, 1341-000938, 1341-000939,
1341-000940, 1341-000941, 1341-000943, 1341-000944, 1341-000945, 1341-000946,
1341-000947, 1341-000948, 1341-000949, 1341-000950, 1341-000951, 1341-000952,
1341-000953, 1341-000954, 1341-000955, 1341-000956, 1341-000957, 1341-000959,
1341-000960, 1341-000961, 1341-000963, 1341-000964, 1341-000965, 1341-000967,
1341-000968, 1341-000970, 1341-000971, 1341-000972, 1341-000973, 1341-000974,
1341-000975, 1341-000976, 1341-000977, 1341-000979, 1341-000981, 1341-000982,
1341-000983, 1341-000985, 1341-000986, 1341-000987, 1341-000988, 1341-001600,
1341-001601, 1341-001602, 1341-001603, 1341-001604, 1341-001605, 1341-001606,
1341-001607, 1341-001608, 1341-001609, 1341-001610, 1341-001611, 1341-001612,
1341-001613, 1341-001614, 1341-001615, 1341-001616, 1341-001617, 1341-001618,
1341-001619, 1341-001620, 1341-001621, 1341-001622, 1341-001623, 1341-001624,
1341-001625, 1341-001626, 1341-001627, 1341-001628, 1341-001629, 1341-001630,
1341-001631, 1341-001632, 1341-001633, 1341-001634, 1341-001635, 1341-001747,
1341-001748, 1341-001888, 1341-001889, 1341-001890, 1341-001891, 1341-001892,
1341-001893, 1341-001894, 1341-001895, 1341-001896, 1341-001897, 1341-001898,
1341-001899, 1341-001900, 1341-001901, 1341-001902, 1341-001903, 1341-001904,
1341-001905, 1341-001906, 1341-001907, 1341-001908, 1341-001909, 1341-001910,
1341-001911, 1341-001912, 1341-001913, 1341-001914, 1341-001915, 1341-001916,
1341-001917, 1341-001918, 1341-001919, 1341-001920, 1341-001921, 1341-001922,
1341-001923, 1341-001924, 1341-001925, 1341-001926, 1341-001927, 1341-001928,
1341-001929, 1341-000381, 1341-000386, 1341-000387, 1341-000391, 1341-000392,
1341-000394, 1341-000397, 1341-000400, 1341-000401, 1341-000402, 1341-000969,
1341-000644, 1341-000645, 1341-000646, 1341-000647, 1341-000648, 1341-001978,
1341-001979, 1341-001980, 1341-001981, 1341-001982, 1341-001983, 1341-001984,
1341-001985, 1341-001986, 1341-001987, 1341-001988, 1341-001989, 1341-001990,
1341-001991, 1341-002078, 1341-002079, 1341-002080, 1341-002081, 1341-001968,
1341-001969, 1341-001970, 1341-001971, 1341-001972, 1341-001973, 1341-001974,
1341-001975, 1341-001488, 1341-001489, 1341-001490, 1341-001491, 1341-001492,
1341-001493, 1341-001494, 1341-001495, 1341-001496, 1341-001497, 1341-001498,
1341-001499, 1341-001500, 1341-001501, 1341-001502, 1341-001503, 1341-001504,
1341-001505, 1341-001506, 1341-001507, 1341-001508, 1341-001509, 1341-001510,
1341-001511, 1341-001512, 1341-001513, 1341-001514, 1341-001515, 1341-001516,
1341-001517, 1341-001518, 1341-001519, 1341-001520, 1341-001521, 1341-001522,
1341-001523, 1341-001524, 1341-001525, 1341-001526, 1341-001527, 1341-001528,
1341-001529, 1341-001530, 1341-001531, 1341-001532, 1341-001533, 1341-001534,
1341-001535, 1341-001536, 1341-001537, 1341-001538, 1341-001539, 1341-001540,
1341-001541, 1341-001542, 1341-001543, 1341-001544, 1341-001545, 1341-001546,
1341-001547, 1341-001548, 1341-001549, 1341-001550, 1341-001551, 1341-001552,
1341-001553, 1341-001554, 1341-001555, 1341-001556, 1341-001557, 1341-001558,
1341-001559, 1341-002024, 1341-002025, 1341-002026, 1341-002163, 1341-001030,
1341-001031, 1341-001032, 1341-001806, 1341-001931, 1341-001932, 1341-000608,
1341-000609, 1341-000687, 1341-000688, 1341-000690, 1341-000691, 1341-000692,
1341-000693, 1341-000694, 1341-000695, 1341-000696, 1341-000697, 1341-000698,
1341-001015, 1341-001016, 1341-001017, 1341-001018, 1341-001019, 1341-001020,
1341-001021, 1341-001022, 1341-001023, 1341-001024, 1341-001025, 1341-001026,
1341-001027, 1341-001392, 1341-001445, 1341-001447, 1341-001449, 1341-001451,
1341-001453, 1341-001458, 1341-001459, 1341-001460, 1341-001461, 1341-001462,
1341-001463, 1341-001464, 1341-001465, 1341-001466, 1341-001467, 1341-001468,
1341-001469, 1341-001470, 1341-001471, 1341-001472, 1341-001473, 1341-001474,
1341-001475, 1341-001476, 1341-001477, 1341-001478, 1341-001479, 1341-001480,
1341-001481, 1341-001482, 1341-001483, 1341-001484, 1341-001485, 1341-001486,
1341-001487, 1341-002027, 1341-002028, 1341-002029, 1341-002030, 1341-002031,
1341-002032, 1341-002033, 1341-002034, 1341-002035, 1341-002038, 1341-002039,
1341-002040, 1341-002041, 1341-002042, 1341-002043, 1341-002044, 1341-002045,
1341-002046, 1341-002047, 1341-002048, 1341-002049, 1341-002050, 1341-002051,
1341-002052, 1341-002082, 1341-002083, 1341-001402, 1341-001403, 1341-001404,
1341-001409, 1341-001410, 1341-001411, 1341-001412, 1341-001413, 1341-001414,
1341-001415, 1341-001416, 1341-001417, 1341-001418, , 1341-000736, 1341-000737,
1341-000738, 1341-000739, 1341-000740, 1341-000741, 1341-000742, 1341-000743,
1341-000744, 1341-000745, 1341-000746, 1341-000747, 1341-000748, 1341-000749,
1341-000750, 1341-000751, 1341-000752, 1341-000753, 1341-000754, 1341-000755,
1341-000756, 1341-000757, 1341-000758, 1341-000759, 1341-000760, 1341-000761,
1341-000762, 1341-000763, 1341-000764, 1341-000765, 1341-000766, 1341-000767,
1341-000768, 1341-000769, 1341-000770, 1341-000771, 1341-000772, 1341-000773,
1341-000774, 1341-000775, 1341-000776, 1341-000777, 1341-000778, 1341-000779,
1341-000780, 1341-000781, 1341-000782, 1341-000783, 1341-000784, 1341-000785,
1341-000786, 1341-000787, 1341-000788, 1341-000789, 1341-000790, 1341-000791,
1341-000792, 1341-000793, 1341-000794, 1341-000795, 1341-000796, 1341-000797,
1341-000798, 1341-000799, 1341-000800, 1341-000801, 1341-000802, 1341-000803,
1341-000804, 1341-000805, 1341-000806, 1341-000807, 1341-000808, 1341-000809,
1341-000810, 1341-000811, 1341-000812, 1341-000813, 1341-000814, 1341-000815,
1341-000816, 1341-000817, 1341-000818, 1341-000819, 1341-000820, 1341-000821,
1341-000822, 1341-000823, 1341-000824, 1341-000825, 1341-000826, 1341-000827,
1341-000828, 1341-000829, 1341-001003, 1341-001004, 1341-001005, 1341-001006,
1341-001007, 1341-001008, 1341-001009, 1341-001010, 1341-001011, 1341-001012,
1341-001013, 1341-001014, 1341-001650, 1341-001651, 1341-001652, 1341-001653,
1341-001654, 1341-001655, 1341-001762, 1341-001763, 1341-001764, 1341-001765,
1341-001766, 1341-001767, 1341-001768, 1341-001769, 1341-001770, 1341-001771,
1341-001772, 1341-001773, 1341-001774, 1341-001775, 1341-001776, 1341-001777,
1341-001778, 1341-001779, 1341-001780, 1341-001781, 1341-001782, 1341-001783,
1341-001784, 1341-001785, 1341-001786, 1341-001787, 1341-001788, 1341-001789,
1341-001790, 1341-002164, 1341-001791, 1341-001792, 1341-001793, 1341-001794,
1341-001795, 1341-001796, 1341-001797, 1341-001798, 1341-001799, 1341-001800,
1341-001801, 1341-001802, 1341-001803, 1341-001804, 1341-001805, 1341-000515,
1341-000249, 1341-000258, 1341-000259, 1341-001241, 1341-001378, 1341-001379,
1341-001380, 1341-001381, 1341-001382, 1341-001383, 1341-001384, 1341-001385,
1341-001386, 1341-001387, 1341-001388, 1341-001389, 1341-001419, 1341-001420,
1341-001421, 1341-001422, 1341-001423, 1341-001424, 1341-001425, 1341-001426,
1341-001427, 1341-001430, 1341-001431, 1341-001432, 1341-001433, 1341-001996,
1341-000689, 1341-001664, 1341-001665, 1341-001666, 1341-001667, 1341-001668,
1341-001669, 1341-001670, 1341-001671, 1341-001672, 1341-001673, 1341-001674,
1341-001675, 1341-001676, 1341-001677, 1341-001678, 1341-001679, 1341-001680,
1341-001681, 1341-001682, 1341-001683, 1341-001684, 1341-001685, 1341-001686,
1341-001687, 1341-001688, 1341-001689, 1341-001690, 1341-001691, 1341-001434,
1341-001435, 1341-001436, 1341-001437, 1341-001438, 1341-001439, 1341-001440,
1341-001441, 1341-001442, 1341-001443, 1341-001444, 1341-000004, 1341-000009,
1341-000025, 1341-000026, 1341-000027, 1341-000028, 1341-000029, 1341-000072,
1341-000073, 1341-000074, 1341-000080, 1341-000081, 1341-000082, 1341-000083,
1341-000084, 1341-000085, 1341-000086, 1341-000087, 1341-000088, 1341-000089,
1341-000090, 1341-000091, 1341-000092, 1341-000093, 1341-000094, 1341-000095,
1341-000096, 1341-000097, 1341-000304, 1341-000305, 1341-000306, 1341-000307,
1341-000308, 1341-000309, 1341-000310, 1341-000311, 1341-000312, 1341-000313,
1341-000314, 1341-000315, 1341-000316, 1341-000317, 1341-000318, 1341-000319,
1341-000409, 1341-000410, 1341-000411, 1341-000412, 1341-000413, 1341-000414,
1341-000415, 1341-000416, 1341-000417, 1341-000418, 1341-000419, 1341-000420,
1341-000421, 1341-000422, 1341-000423, 1341-000424, 1341-000425, 1341-000426,
1341-001757, 1341-001930, 1341-002122, 1341-002123, 1341-002124, 1341-002125,
1341-002126, 1341-000452, 1341-000453, 1341-000454, 1341-000455, 1341-000456,
1341-000457, 1341-000458, 1341-000459, 1341-000460, 1341-000461, 1341-000462,
1341-000463, 1341-000464, 1341-000465, 1341-000466, 1341-000467, 1341-000468,
1341-000469, 1341-000470, 1341-000471, 1341-000472, 1341-000473, 1341-000474,
1341-000475, 1341-000476, 1341-000477, 1341-000478, 1341-000479, 1341-000480,
1341-000481, 1341-000482, 1341-000483, 1341-000484, 1341-000485, 1341-000486,
1341-000487, 1341-000488, 1341-000489, 1341-000490, 1341-000491, 1341-000492,
1341-000493, 1341-000494, 1341-000495, 1341-000496, 1341-000497, 1341-000498,
1341-001756, 1341-002014, 1341-002015, 1341-001560, 1341-001561, 1341-001562,
1341-001563, 1341-001564, 1341-001565, 1341-001566, 1341-001567, 1341-001568,
1341-001569, 1341-001570, 1341-001571, 1341-001572, 1341-001573, 1341-001574,
1341-001575, 1341-001576, 1341-001577, 1341-001578, 1341-001579, 1341-001580,
1341-001581, 1341-001582, 1341-001583, 1341-001584, 1341-001585, 1341-001586,
1341-001587, 1341-001588, 1341-001589, 1341-001590, 1341-001591, 1341-001592,
1341-001593, 1341-001594, 1341-001595, 1341-001596, 1341-001597, 1341-001598,
1341-001599, 1341-000989, 1341-000990, 1341-000991, 1341-000992, 1341-000993,
1341-000994, 1341-000995, 1341-000996, 1341-000997, 1341-000998, 1341-000999,
1341-001000, 1341-001001, 1341-001002, 1341-001089, 1341-001090, 1341-001091,
1341-001092, 1341-001093, 1341-001094, 1341-000116, 1341-000117, 1341-000118,
1341-000119, 1341-000120, 1341-000121, 1341-000122, 1341-000123, 1341-000124,
1341-000125, 1341-000126, 1341-000127, 1341-000128, 1341-000129, 1341-000130,
1341-000131, 1341-000132, 1341-000133, 1341-000134, 1341-000135, 1341-000136,
1341-000137, 1341-000138, 1341-000139, 1341-000140, 1341-000141, 1341-000142,
1341-000143, 1341-000144, 1341-000145, 1341-000146, 1341-000147, 1341-000148,
1341-000149, 1341-000150, 1341-000151, 1341-000267, 1341-000268, 1341-000269,
1341-000270, 1341-000271, 1341-000272, 1341-000273, 1341-000274, 1341-000275,
1341-000276, 1341-000277, 1341-000278, 1341-000279, 1341-000280, 1341-000281,
1341-000282, 1341-000283, 1341-000284, 1341-000285, 1341-000286, 1341-000287,
1341-000288, 1341-000289, 1341-000290, 1341-000291, 1341-000292, 1341-000293,
1341-000294, 1341-000295, 1341-000296, 1341-000297, 1341-000298, 1341-000299,
1341-000300, 1341-000301, 1341-000302, 1341-000303, 1341-001285, 1341-001299,
1341-001300, 1341-001301, 1341-001302, 1341-001303, 1341-001304, 1341-001305,
1341-001306, 1341-001307, 1341-001308, 1341-001309, 1341-001310, 1341-001311,
1341-001312, 1341-001313, 1341-001314, 1341-001315, 1341-001316, 1341-001317,
1341-001318, 1341-001319, 1341-001320, 1341-001321, 1341-001322, 1341-001323,
1341-001324, 1341-001325, 1341-001326, 1341-001327, 1341-001328, 1341-001329,
1341-001330, 1341-001331, 1341-001332, 1341-001333, 1341-001334, 1341-001335,
1341-001336, 1341-001337, 1341-001338, 1341-001339, 1341-001340, 1341-001341,
1341-001342, 1341-001343, 1341-001344, 1341-001345, 1341-001346, 1341-001347,
1341-001348, 1341-001349, 1341-001350, 1341-001351, 1341-001352, 1341-001353,
1341-001354, 1341-001355, 1341-001356, 1341-001357, 1341-001358, 1341-001359,
1341-001360, 1341-001361, 1341-001362, 1341-001363, 1341-001364, 1341-001365,
1341-001366, 1341-001367, 1341-001368, 1341-001369, 1341-001370, 1341-001371, ,
1341-001693, 1341-001694, 1341-001695, 1341-001696, 1341-001697, 1341-001698, ,
1341-000011, 1341-000012, 1341-000013, 1341-000014, 1341-000015, 1341-000016,
1341-000017, 1341-000018, 1341-000019, 1341-000020, 1341-000021, 1341-000022,
1341-000023, 1341-000024, 1341-000030, 1341-000031, 1341-000032, 1341-000033,
1341-000034, 1341-000035, 1341-000036, 1341-000037, 1341-000038, 1341-000039,
1341-000040, 1341-000041, 1341-000042, 1341-000043, 1341-000044, 1341-000045,
1341-000046, 1341-000047, 1341-000048, 1341-000049, 1341-000050, 1341-000051,
1341-000052, 1341-000053, 1341-000054, 1341-000055, 1341-000056, 1341-000057,
1341-000058, 1341-000059, 1341-000060, 1341-000061, 1341-000062, 1341-000063,
1341-000064, 1341-000065, 1341-000066, 1341-000067, 1341-000068, 1341-000069,
1341-000070, 1341-000071, 1341-000075, 1341-000076, 1341-000077, 1341-000078,
1341-000079, 1341-000448, 1341-000449, , 1341-000682, 1341-000683, 1341-000684,
1341-000685, 1341-000686, 1341-001751, 1341-001752, 1341-001753, 1341-001754,
1341-001755, , 1341-000703, 1341-000704, 1341-000705, 1341-000706, 1341-000707,
1341-000708, 1341-000709, 1341-000710, 1341-000711, 1341-000712, 1341-000713,
1341-000714, 1341-000715, 1341-000716, 1341-000717, 1341-000718, 1341-000719,
1341-000720, 1341-000721, 1341-000722, 1341-000723, 1341-000724, 1341-000725,
1341-000726, 1341-000727, 1341-000728, 1341-000729, 1341-000730, 1341-000731,
1341-000732, 1341-000733, 1341-000734, 1341-000735, 1341-001807, 1341-001808,
1341-001809, 1341-001810, 1341-001811, 1341-001812, 1341-001813, 1341-001814,
1341-001815, 1341-001816, 1341-001817, 1341-001818, 1341-001819, 1341-001820,
1341-001821, 1341-001822, 1341-001823, 1341-001824, 1341-001825, 1341-001829,
1341-001830, 1341-001831, 1341-001832, 1341-001833, 1341-001834, 1341-001835,
1341-001836, 1341-001837, 1341-001838, 1341-001839, 1341-001840, 1341-001841,
1341-001842, 1341-001843, 1341-001844, 1341-001845, 1341-001846, 1341-001847,
1341-001848, 1341-001849, 1341-001850, 1341-001851, 1341-001852, 1341-001853,
1341-001854, 1341-001855, 1341-001856, 1341-001857, 1341-001858, 1341-001859,
1341-001860, 1341-001861, 1341-001862, 1341-001863, 1341-001864, 1341-001865,
1341-001866, 1341-001867, 1341-001868, 1341-001869, 1341-001870, 1341-001871,
1341-001872, 1341-001873, 1341-001874, 1341-001875, 1341-001876, 1341-001877,
1341-001878, 1341-001879, 1341-001880, 1341-001881, 1341-001882, 1341-001883,
1341-001884, 1341-001885, 1341-011826, 1341-011827, 1341-011828, 1341-000192,
1341-000193, 1341-000194, 1341-000195, 1341-000196, 1341-000197, 1341-000198,
1341-000199, 1341-000200, 1341-000201, 1341-000202, 1341-000203, 1341-000204,
1341-000205, 1341-000206, 1341-000207, 1341-000208, 1341-000209, 1341-000210,
1341-000211, 1341-000212, 1341-000213, 1341-000214, 1341-000215, 1341-000216,
1341-000217, 1341-000218, 1341-000219, 1341-000220, 1341-000221, 1341-000222,
1341-000223, 1341-000224, 1341-000225, 1341-000226, 1341-000227, 1341-000228,
1341-000229, 1341-000230, 1341-000231, 1341-000232, 1341-000233, 1341-000925,
1341-000926, 1341-000927, 1341-000928, 1341-001992, 1341-001993, 1341-001994,
1341-001995, 1341-001997, 1341-001998, 1341-001999, 1341-002000, 1341-002001,
1341-002002, 1341-002003, 1341-002004, 1341-002005, 1341-002006, 1341-002007,
1341-002008, 1341-002009, 1341-002010, 1341-002011, 1341-002012, 1341-002013,
1341-002016, 1341-002017, 1341-002018, 1341-002019, 1341-002020, 1341-002021,
1341-002022, 1341-002023, 1341-002053, 1341-002054, 1341-002055, 1341-002056,
1341-002057, 1341-002058, 1341-002059, 1341-002060, 1341-002061, 1341-002062,
1341-002063, 1341-002064, 1341-002065, 1341-002066, 1341-002067, 1341-002068,
1341-002069, 1341-002070, 1341-002071, 1341-002072, 1341-002073, 1341-002074,
1341-002075, 1341-002076, 1341-002077, 1341-002084, 1341-002085, 1341-002086,
1341-002087, 1341-002088, 1341-002089, 1341-002090, 1341-002091, 1341-002092,
1341-002093, 1341-002094, 1341-002095, 1341-002096, 1341-002097, 1341-002098,
1341-002099, 1341-002100, 1341-002101, 1341-002102, 1341-002103, 1341-002104,
1341-002105, 1341-002106, 1341-002107, 1341-002108, 1341-002109, 1341-002110,
1341-002111, 1341-002112, 1341-002113, 1341-002114, 1341-002115, 1341-002116,
1341-002118, 1341-002119, 1341-002120, 1341-002121, 1341-002127, 1341-002128,
1341-002129, 1341-002130, 1341-002131, 1341-002132, 1341-002133, 1341-002134,
1341-002135, 1341-002136, 1341-002137, 1341-002138, 1341-002139, 1341-002140,
1341-002141, 1341-002142, 1341-002159, 1341-002160, 1341-002161, 1341-002165,
1341-002166, 1341-002167, 1341-002168, 1341-002169, 1341-002170, , 1341-000649,
1341-000650, 1341-000651, 1341-000652, 1341-000653, 1341-000654, 1341-000655,
1341-000656, 1341-000657, 1341-000658, 1341-000659, 1341-000660, 1341-000661,
1341-000662, 1341-000663, 1341-000664, 1341-000665, 1341-000666, 1341-000667,
1341-000668, 1341-000669, 1341-000670, 1341-000671, 1341-000672, 1341-000673,
1341-000674, 1341-000675, 1341-000676, 1341-000677, 1341-000678, 1341-000679,
1341-000680, 1341-000681, 1341-001060, 1341-001061, 1341-001062, 1341-001063,
1341-001064, 1341-001065, 1341-001066, 1341-001067, 1341-001068, 1341-001069,
1341-001070, 1341-001071, 1341-001072, 1341-001073, 1341-001074, 1341-001075,
1341-001076, 1341-001077, 1341-001078, 1341-001079, 1341-001080, 1341-001081,
1341-001082, , 1341-000152, 1341-000153, 1341-000154, 1341-000155, 1341-000156,
1341-000157, 1341-000158, 1341-000159, 1341-000160, 1341-000161, 1341-000162,
1341-000163, 1341-000164, 1341-000165, 1341-000166, 1341-000167, 1341-000168,
1341-000169, 1341-000170, 1341-000171, 1341-000172, 1341-000173, 1341-000174,
1341-000175, 1341-000176, 1341-000177, 1341-000178, 1341-000179, 1341-000180,
1341-000181, 1341-000182, 1341-000183, 1341-000184, 1341-000185, 1341-000186,
1341-000187, 1341-000188, 1341-000189, 1341-000190, 1341-000191, 1341-001158,
1341-001163, 1341-001164, 1341-001165, 1341-001166, 1341-001167, 1341-001168,
1341-001169, 1341-001170, 1341-001171, 1341-001172, 1341-001173, 1341-001174,
1341-001175, 1341-001176, 1341-001177, 1341-001178, 1341-001179, 1341-001180,
1341-001181, 1341-001182, 1341-001183, 1341-001184, 1341-001185, 1341-001186,
1341-001187, 1341-001188, 1341-001189, 1341-001190, 1341-001191, 1341-001192,
1341-001193, 1341-001194, 1341-001195, 1341-001196, 1341-001197, 1341-001198,
1341-001199, 1341-001200, 1341-001201, 1341-001275, 1341-001405, 1341-001406,
1341-001407, and 1341-001408
RECALLING
FIRM/MANUFACTURER Spacelabs Healthcare, Inc., Issaquah, WA,
REASON
During battery insertion there is
potential for patient waveforms to move to an open receiver module or to an
occupied receiver causing the intermittent inappropriate monitoring of both
patients for several minutes.
VOLUME OF PRODUCT IN
COMMERCE 2,055 units
DISTRIBUTION Nationwide
PRODUCT HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A
HeartStart MRx with a native 256Mbyte internal memory card with date code "0308.
The product is used for the termination of ventricular tachycardia and
ventricular fibrillation,
CODE
Serial Numbers: US00100694- US00100695
US00101003 US00101148 US00101277 US00101427 US00101443 US00101696 US00101876
US00102033 US00102552 US00102602 US00202756 US00202955 US00203505 US00203923
US00204295 US00204347 US00204361 US00204423 US00204438 US00204490 US00204648
US00205100 US00205625 US00205636 US00205650- US00205651 US00205660 US00205666
US00205688 US00205751 US00205839 US00205994 US00206144 US00206531 US00206641
US00207021 US00207313 US00207485 US00207604 US00207924 US00207930 US00208087
US00208140 US00208752 US00208789- US00208790 US00209355 US00209715 US00210183
US00210304 US00210783 US00210982 US00212242 US00212790 US00315280 US00315447
US00315464 US00316930 US00318057 US00318523 US00318538 US00319936 US00321428
US00324554 US00324581- US00324584 US00324586 US00324614- US00324616 US00324619-
US00324620 US00324622 US00324624- US00324625 US00324627 US00324642 US00324645-
US00324646 US00324659 US00324680 US00324707 US00324712- US00324713 US00324718
US00324720 US00324727- US00324731 US00324734 US00324736 US00324744 US00324748-
US00324749 US00324751 US00324754 US00324756 US00324758- US00324761 US00324763-
US00324765 US00324767- US00324769 US00324771 US00324773 US00324775 US00324777
US00324779- US00324786 US00324788- US00324789 US00324802- US00324838 US00324841-
US00324845 US00324847- US00324856 US00324858- US00324929 US00324932- US00324942
US00324944 US00324947- US00324952 US00324954 US00324956- US00324959 US00324961-
US00324968 US00324970- US00324971 US00324973- US00324975 US00324979- US00324980
US00324982 US00324984 US00324986 US00324997 US00325003 US00325005 US00325007-
US00325008 US00325010 US00325023- US00325024 US00325028 US00325031- US00325032
US00325035 US00325038 US00325040- US00325043 US00325045 US00325048- US00325049
US00325054- US00325057 US00325062- US00325064 US00325066 US00325068- US00325069
US00325081- US00325082 US00325085- US00325087 US00325094- US00325096 US00325166
US00325231 US00325234- US00325235 US00325583- US00325587 US00325612- US00325613
US00325616 US00325621 US00325623- US00325624 US00325628 US00325651 US00325654-
US00325655 US00325661- US00325664 US00325674- US00325690 US00325692 US00325694
US00325696- US00325701 US00325703- US00325726 US00325728- US00325731 US00325734-
US00325742 US00325744- US00325746 US00325748- US00325755 US00325757- US00325759
US00325762- US00325763 US00325766- US00325768 US00325770- US00325771 US00325773-
US00325775 US00325780- US00325781 US00325787- US00325790 US00325795- US00325797
US00325799- US00325800 US00325804 US00325806- US00325808 US00325810 US00325812-
US00325814 US00325816- US00325823 US00325827- US00325828 US00325830- US00325838
US00325847- US00325848 US00325851- US00325853 US00325856 US00325858- US00325859
US00325861 US00325863 US00325867 US00325870- US00325871 US00325873- US00325875
US00325877- US00325878 US00325889 US00325903 US00325908- US00325909 US00325943
US00325957 US00325979 US00325994 US00326002 US00326008 US00326034 US00326043
US00326058 US00326061- US00326065 US00326069 US00326073- US00326075 US00326079
US00326084 US00326225 US00326248 US00326350 and US00326505
RECALLING
FIRM/MANUFACTURER Philips Medical Systems, Andover, MA,
REASON
Defective internal memory cards may
exhibit one or more of the following behaviors: "Device repeatedly restarts
approximately every 20 seconds "Slow device start-up of approximately 15 seconds
or more. During this time, the MRx displays either a blank screen or the Philips
HeartStart MRx Start-up screen prior to displaying the selected mode of
operation (i.e. Monitor, AED, Pacing or Manual Defib mode). " Internal Memory
Failure INOP message when attempting to print an event from the Data Management
screen. "When printing from the Data Management screen, a patients Event Summary
prints with some clinical events missing.
VOLUME OF PRODUCT IN
COMMERCE 523 units
DISTRIBUTION Nationwide,
Canada Australia, Brazil , China, France, Germany, Great Britain, Hong Kong,
Indonesia, Italy, Latvia, New Zealand, Saudi Arabia, and South Africa
PRODUCT Sunrise
Medical Quickie Groove Power Wheelchair with Transit option The product is a
powered wheelchair for human use,
CODE Multiple serial numbers, starting with
GRV-100: 182, 181, 178, 176, 166, 161, 160, 151, 150, 115, 110, 109, 106, 100,
099, 098, 094, 082, 081, 079, 076, 073, 064, 058, 056, 054, 053, 050, 044, 043,
041, 040, 035, 033, 021 and 013
RECALLING
FIRM/MANUFACTURER Sunrise Medical, Inc., Fresno, CA,
REASON Rear bolts holding the frame in place may shear
and the front bolts may potentially come off the posts, resulting in partial or
full seat detachment in a sudden stop or crash.
VOLUME OF PRODUCT IN
COMMERCE 36 units
DISTRIBUTION Nationwide,
Canada, New Zealand and
Australia
PRODUCT
a) Exact Calcar Planer Rasp Style Blade, 38mm, REF 31-473795.
Surgical blades used to remove excess bone proximal to the broach face to all
instrument trial to seat properly,
b) Exact Calcar
Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF
31-473796. Surgical blades used to remove excess bone proximal to the broach
face to all instrument trial to seat properly,
c)
Exact Calcar Planer Rasp Style Blade, 46mm; REF 31-473797. Surgical blades used
to remove excess bone proximal to the broach face to all instrument trial to
seat properly,
d) Exact Calcar Planer Rasp Style
Blade, 50mm; REF 31-473798. Surgical blades used to remove excess bone proximal
to the broach face to all instrument trial to seat properly,
CODE
a) Lots 739370, 442250, 848550 and
904090;
b) Lots 010180, 865890, 439380, 850170 and 918020;
c) Lots 850560,
439390, 848560 and 918030;
d) Lot 834190
RECALLING
FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN,
REASON The blades
will oxidize after the first cleaning.
VOLUME OF PRODUCT IN
COMMERCE 141 units
DISTRIBUTION Nationwide
and China
PRODUCT
a) Access and Access 2 Immunoassay System,
b) SYNCHRON LXi 725 System,
c) Unicel
DxC 600i System and Unicel Dxl 600 Access Immunoassay System,
d) UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i
Synchron Access Clinical System,
CODE
a) and b) Peristaltic
Pumps with Serial Numbers above 22349820;
c) Unicel DxC 600i with Peristaltic
Pumps with Serial Numbers above 22349820; Unicel Dxl 600 Peristaltic Pumps with
Serial Numbers of 22965501 and above;
d) Peristaltic Pumps with Serial
Numbers of 22454201 and above
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Beckman Coulter Inc.,
Fullerton, CA. REASON The field action was initiated after the
firm confirmed reports of premature failure of the waste pump tubing in the
Access and Access 2 Immunoassay Systems. Premature failure of the waste pump
tubing may negatively affect precision.
VOLUME OF PRODUCT IN
COMMERCE 694 units
DISTRIBUTION Nationwide,
and Canada
PRODUCT
NicoletOne photic adapter cable 085-463700,
CODE 085-463700
RECALLING
FIRM/MANUFACTURER Cardinal Health NeuroCare Division, Madison, WI
REASON
The photic adapter cable has a wiring
error which delivers a reduced voltage and results in a decreased intensity of
the NicLED photic. This reduced intensity may fail to elicit a response from a
photosensitive seizure disorder patient which may result in lack of appropriate
treatment for this disorder.
VOLUME OF PRODUCT IN
COMMERCE 92 units
DISTRIBUTION CA FL GA ID IN
LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico
Netherlands Russia Saudi Arabia Slovenia
PRODUCT
a)
Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex
free. The device is intended to be used as a urinary incontinence device
designed to drain urine from the bladder,
b)
Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex
free. The device is intended to be used as a urinary incontinence device
designed to drain urine from the bladder,
c)
Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex
free. The device is intended to be used as a urinary
incontinence device designed to drain urine from the
bladder,
d) Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No.
1036, Sterile, Latex free. The device is intended to be
used as a urinary incontinence device designed to drain urine from the bladder,
e) Apogee Intermittent Catheter with Coude tip, 14
Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The
device is intended to be used as a urinary incontinence device designed to drain
urine from the bladder,
CODE
a) Lot
number 7208;
b) and c) Lot number 7206;
d) Lot number 6016;
e) Lot
number 7201
RECALLING FIRM/MANUFACTURER Apogee Medical,
Inc., Youngsville, NC,
REASON Due to a package seal defect the catheter
tip may have been inadvertently cut which could cause trauma to the urethra upon
use. Also the sterility of the product could be compromised.
VOLUME
OF PRODUCT IN COMMERCE 23.400
devices
DISTRIBUTION Nationwide and
Canada
PRODUCT
Power Drive. Battery-driven power tool system intended for use
during surgical procedures to provide power to operate various accessories and
attachments. Catalog number 530.100,
CODE All lot numbers
RECALLING
FIRM/MANUFACTURER Synthes U S A, West Chester, PA,
Manufacturer: Synthes
Gmbh, Oberdorf, Switzerland. REASON The product is mislabeled, as the validation for
the previous sterilization parameters cannot be replicated. The currently
validated sterilization parameter is a minimum of 24 minutes prevacuum.
VOLUME OF PRODUCT IN COMMERCE
584
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm
From Tip), Catalog No./REF 10303101. Sterile,
b) Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm
From Tip), Catalog No./REF 10303102. Sterile,
c) Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm
From Tip), Catalog No./REF 10303103. Sterile,
CODE
a) Lot numbers: S08B01, S08B05, S08C02,
and S08C07;
b) Lot numbers: S08B02, S08B06, S08C01, S08D02, and S08D11;
c)
Lot numbers: S08B03, S08C03, S08C04, and S08C08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Angiodynamics, Inc.,
Queensbury, NY, Manufacturer: Via
Biomedical, Maple Grove, MN.
REASON The cuff may be inadequately attached to
the catheter, resulting in possible catheter movement or leakage at the
insertion site.
VOLUME OF PRODUCT IN COMMERCE 1,490
units
DISTRIBUTION Nationwide
PRODUCT
a) PLAC Test Reagent Kit, Catalog numbers 90107 and 90110,
Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human
plasma or serum. Product consists of a liquid, ready to use, two reagent kit
assembled in a kit box,
b) PLAC Test ELISA kit,
catalog number 90106, enzyme immunoassay for the quantitative determination of
Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate
and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash
buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL, CODE
All lots
RECALLING
FIRM/MANUFACTURER DiaDexus, Inc., South San Francisco, CA,
REASON
Product may give Lp-PLA2 values at up to
22% lower than accurate values.
VOLUME OF PRODUCT IN
COMMERCE 65 units
DISTRIBUTION Nationwide, UK
and Germany
PRODUCT
GE Voluson® E8 Ultrasound System with software versions 6.0.0,
6.0.1, 6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a
qualified physician for ultrasound evaluation of Fetal OB; abdominal (including
GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small
Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac
(adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral
Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal ,
PV neurological),
CODE
Serial
numbers: D00854 D03101 D03423 D00152 D00289 D00323 D00408 D00414 D00477 D00482
D00676 D00679 D00838 D00866 D03109 D03172 D03401 D03422 D03441 D03626 D03849
D03855 D03119 D03683 D03866 D00160 D00212 D00283 D00320 D00377 D00427 D00463
D00678 D01032 D01038 D03206 D03287 D03358 D03391 D03498 D03625 D00811 D00832
D03154 D00578 D03492 D03617 D03644 D03677 D03743 D03295 D00161 D00329 D00370
D00371 D00472 D00588 D00589 D00921 D00229 D00164 D00664 D00979 D00998 D01001
D03216 D03655 D00181 D00191 D00269 D00390 D00709 D00717 D00786 D00805 D00882
D00883 D00885 D00886 D00891 D01021 D00857 D03478 D00123 D00530 D00942 D00947
D00948 D01066 D03400 D03427 D03442 D03704 D03183 D03864 D00361 D00737 D03384
D03712 D00738 D00144 D03440 D03233 D03488 D00620 D00895 D00985 D03643 D00211
D00743 D03196 D03342 D03402 D03654 D03742 D03765 D03776 D03779 D03780 D03845
D00724 D00731 D03507 D03490 D03493 D03494 D03495 D00363 D00368 D03382 D00515
D00131 D00309 D00334 D00429 D00874 D03581 D00699 D03628 D00146 D00179 D00202
D00208 D00215 D00221 D00237 D00257 D00260 D00263 D00265 D00268 D00271 D00285
D00286 D00353 D00358 D00439 D00458 D00479 D00489 D00511 D00518 D00538 D00598
D00600 D00605 D00621 D00648 D00660 D00661 D00673 D00675 D00708 D00714 D00732
D00845 D00848 D00865 D00896 D00909 D00937 D00944 D00945 D00961 D01010 D01011
D01062 D03110 D03111 D03138 D03148 D03159 D03173 D03207 D03267 D03269 D03280
D03296 D03310 D03322 D03327 D03331 D03332 D03333 D03336 D03343 D03351 D03352
D03354 D03355 D03362 D03364 D03365 D03367 D03368 D03369 D03374 D03375 D03376
D03379 D03381 D03418 D03424 D03456 D03491 D03523 D03532 D03533 D03540 D03545
D03550 D03577 D03597 D03598 D03600 D03601 D03602 D03603 D03604 D03605 D03606
D03607 D03610 D03612 D03614 D03615 D03616 D03664 D03665 D03672 D03673 D03675
D03678 D03682 D03684 D03706 D03720 D03721 D03722 D03726 D03732 D03761 D03763
D03816 D03833 D03843 D00145 D00196 D00201 D00204 D00205 D00206 D00207 D00216
D00219 D00274 D00275 D00276 D00281 D00287 D00410 D00438 D00447 D00496 D00527
D00596 D00610 D00674 D00842 D00899 D00967 D01045 D03102 D03113 D03117 D03131
D03285 D03301 D03313 D03325 D03326 D03328 D03348 D03360 D03366 D03371 D03378
D03431 D03474 D03536 D03585 D03595 D03666 D03667 D03671 D03676 D03679 D03681
D03783 D00117 D00121 D00138 D00141 D00150 D00165 D00167 D00170 D00171 D00183
D00218 D00253 D00256 D00259 D00261 D00267 D00273 D00311 D00313 D00315 D00328
D00378 D00383 D00385 D00431 D00441 D00448 D00461 D00606 D00607 D00614 D00615
D00617 D00618 D00623 D00681 D00716 D00830 D00860 D00861 D00862 D00867 D00871
D00872 D00873 D00901 D00935 D00955 D00988 D03118 D03120 D03132 D03161 D03175
D03176 D03189 D03194 D03270 D03361 D03388 D03389 D03390 D03404 D03405 D03408
D03413 D03414 D03420 D03425 D03428 D03429 D03430 D03483 D03512 D03515 D03522
D03525 D03530 D03565 D03583 D03586 D03591 D03592 D03596 D03629 D03641 D03642
D03647 D03649 D03740 D03769 D00154 D00177 D00190 D00234 D00235 D00245 D00247
D00262 D00264 D00443 D00457 D00462 D00536 D00612 D00613 D00650 D00667 D00869
D00870 D00914 D00930 D00984 D00994 D01067 D03011 D03265 D03284 D03297 D03372
D03406 D03407 D03409 D03573 D03594 D03646 D03668 D03674 D03689 D03738 D03805
D00143 D00590 D00828 D03123 D03141 D03209 D03212 D03417 D03527 D03685 D00941
D00723 D00483 D00498 D00719 D00728 D01008 D01056 D03453 D03657 D03719 D00394
D03251 D03852 D00288 D00736 D03377 D03457 D03476 D03477 D00308 D00905 D03450
D03465 D00122 D00499 D00622 D00730 D00807 D00812 D00829 D00878 D00943 D03502
D03503 D03505 D03526 D03531 D03554 D03567 D03691 D03725 D03744 D03754 D00156
D00424 D00535 D00818 D00839 D00879 D00970 D01051 D03524 D03699 D00113 D00434
D00868 D03105 D03260 D03528 D03659 D03696 D00950 D00954 D00958 D00959 D03660
D03661 D03728 D03756 D00332 D00722 D00933 D00949 D00322 D01015 D03609 D00508
D03394 D03396 D03290 D03717 D01039 D01040 D00240 D00756 D00934 D00946 D01018
D03433 D00126 D03397 D00272 D00971 D03171 D00341 D03818 D00692 D00504 D00680
D00974 D03737 D00478 D00645 D01012 D03658 D03104 D00533 D00982 D00507 D03762
D03289 D03403 D03475 D00279 D00688 D00521 D03707 D00278 D00407 D00449 D03385
D03392 D03432 D03460 D00128 D00277 D00529 D00534 D00634 D00643 D00690 D00980
D00981 D01014 D01016 D03416 D03448 D03454 D03470 D03472 D03479 D03727 D03749
D00419 D00644 D00682 D00721 D03703 D00684 D01013 D00663 D00486 D00528 D00583
D00641 D00647 D00672 D01052 D01053 D01055 D03164 D03182 D03191 D03198 D03231
D03249 D03275 D03282 D03294 D03299 D03349 D03357 D03383 D03393 D03395 D03398
D03399 D03419 D03426 D03608 D03631 D03736 D00474 D03439 D00475 D00635 D00713
D01017 D03230 D03410 D03630 D03634 D00939 D00157 D00338 D00686 D03179 D03537
D03651 D03652 D01076 D03438 D03443 D03690 D00687 D00917 D00514 D03618 D03686
D03808 D00876 D01046 D03656 D00225 D00677 D03819 D00646 D01070 D01073 D03582
D03611 D03786 D03789 D03790 D03791 D03792 D03830 D03848 D03850 D03851 D00217
D00153 D00222 D00248 D00591 D00599 D03155 D03192 D03201 D03140 D03637 D03386
D00321 D03135 D03356 D00432 D00473 D03387 D03580 D03624 D00799 D00964 D00966
D00440 D00911 D03359 D03363 D03373 D03782 D00466 D00611 D00898 D00975 D03200
D03486 D00409 D00494 D00659 D03858 D03547 D03853 D00501 D03543 D03552 D03555
D03584 D03599 D00446 D00500 D00890 D03293 D03648 D00951 D03796 D03827 D03846
D03860 D00442 D01050 D01057 D03688 D00453 D00452 D03116 D03521 D00101 D00471
D03662 D00436 D00755 D00841 D00846 D00922 D00956 D01061 D03108 D03250 D03412
D03473 D03482 D03504 D03508 D03518 D03535 D03632 D03700 D00151 D00734 D00750
D00877 D03170 D03286 D03734 D03772 D00524 D00603 D00604 D00324 D00417 D00428
D00601 D00602 D00642 D00815 D00831 D00875 D00880 D00881 D01059 D03716 D03785
D03836 D00238 D00932 D03444 D03553 D03619 D00148 D00213 D00301 D00510 D00597
D00833 D01058 D03106 D03464 D03467 D03735 D03593 D01047 D00729 D00851 D00915
D00999 D03350 D03645 D00369 D03653 D00584 D00657 D00952 D00280 D00342 D03587
D01071 D03773 D00624 D01069 D00595 D01077 D03520 D03588 D03590 D00103 D00155
D00166 D00180 D00250 D00251 D00255 D00325 D00331 D00430 D00444 D00454 D00464
D00470 D00476 D00497 D00509 D00513 D00522 D00526 D00547 D00549 D00553 D00555
D00556 D00557 D00559 D00585 D00671 D00691 D00753 D00843 D00852 D00863 D00893
D00913 D01030 D01031 D01072 D03246 D03248 D03314 D03435 D03513 D03548 D03556
D03575 D03576 D03578 D03798 D00294 D00382 D00384 D00668 D01044 D00544 D00545
D03680 D03730 D03731 D03807 D00102 D00379 D00381 D00386 D00387 D00433 D00540
D00586 D00609 D00662 D00683 D00766 D00844 D00864 D00957 D01043 D01048 D01054
D03005 D03114 D03125 D03190 D03245 D03252 D03271 D03272 D03277 D03278 D03279
D03562 D03589 D03613 D03633 D03640 D03650 D03698 D03708 D03710 D03739 D03741
D03771 D03800 D03802 D03809 D03810 D03811 D03839 D00233 D00517 D00523 D00525
D00542 D00822 D03199 D03241 D03484 D03340 D03311 D00343 D00630 D00669 D00793
D00800 D00973 D00990 D03236 D03242 D03449 D03480 D03487 D03781 D03806 D03345
D03276 D03330 D03339 D00193 D00197 D00303 D00304 D00306 D00307 D00349 D00356
D00359 D00367 D00372 D00375 D00412 D00465 D00490 D00495 D00552 D00558 D00566
D00571 D00574 D00580 D00581 D00638 D00665 D00703 D00735 D00745 D00751 D00767
D00769 D00776 D00788 D00795 D00809 D00889 D00938 D00987 D00989 D01007 D03144
D03273 D03283 D03347 D03370 D03461 D03466 D03489 D03511 D03541 D03621 D03787
D03815 D03822 D03826 D03829 D00592 D00480 D00701 D00725 D00801 D00884 D00326
D00337 D00347 D00411 D00469 D00631 D03825 D00720 D03264 D03497 D03514 D03516
D03559 D03560 D03561 D03563 D03564 D03566 D03568 D03569 D03570 D03571 D03572
D03574 D03579 D00492 D00139 D00451 D00992 D00996 D01004 D03733 D03801 D00485
D00502 D00636 D00707 D00718 D03137 D00258 D00350 D00351 D00364 D00554 D00903
D00910 D01020 D03195 D03455 D03458 D00168 D00186 D00203 D00224 D00242 D00249
D00310 D00317 D00388 D00445 D00561 D00582 D00768 D00772 D03149 D03274 D03341
D00632 D03261 D03485 D03509 D00173 D00236 D00244 D00330 D00339 D00340 D00694
D00695 D00758 D00760 D00765 D00775 D00778 D00782 D00794 D00995 D03133 D03324
D03334 D00182 D00254 D00398 D00649 D00742 D00810 D00819 D03153 D03187 D03202
D03213 D03215 D03220 D03223 D03232 D03259 D03320 D03335 D03447 D03549 D03759
D03764 D03774 D03777 D03813 D00415 D00627 D00640 D00656 D00797 D00968 D01033
D01037 D03129 D03130 D03235 D03499 D00189 D00192 D00195 D00200 D00209 D00366
D00393 D00468 D00953 D00972 D03169 D00418 D00481 D00487 D00563 D00570 D00573
D00575 D00579 D00666 D00816 D01024 D03160 D00178 D03152 D03225 D03255 D03337
D03462 D03463 D03517 D03534 D03558 D00421 D00516 D00543 D00920 D01009 D01035
D03304 D03459 D00314 D00142 D00395 D00405 D00413 D00425 D00562 D00564 D00567
D00693 D03107 D03115 D03122 D03185 D03211 D03222 D03224 D03228 D03229 D03253
D03256 D03298 D03309 D03338 D03353 D03380 D03415 D03446 D03451 D03452 D03755
D03799 D03803 D03812 D00300 D00158 D00344 D00352 D00397 D00403 D00460 D00541
D00548 D00888 D00892 D00894 D03240 D03436 D03437 D03821 D00176 D00316 D00423
D00435 D00791 D00826 D00897 D00912 D03145 D03214 D03346 D00711 D00712 D00726
D00727 D00887 D00228 D00246 D00302 D00399 D00493 D00653 D00655 D00963 D00978
D00336 D00392 D00420 D00422 D00625 D00633 D00639 D00652 D00763 D00813 D00993
D03126 D03162 D03167 D03227 D03254 D03288 D03300 D03344 D03820 D00293 D00346
D00503 D00512 D00531 D00546 D00565 D00741 D00749 D00752 D03157 D03165 D03268
D03748 D03751 D03775 D01019 D03219 D00977 D00292 D00296 D03147 D03234 D03302
D03421 D03501 D00568 D00577 D00923 D00931 D00936 D03136 D03197 D03217 D03218
D03221 D03243 D03308 D03316 D03318 D03321 D03329 D03500 D03551 D03622 D03623
D00108 D03747 D03750 D03752 D00685 D00696 D00733 D00777 D00781 D00787 D00789
D03319 D03323 D03445 D03510 D00223 D00239 D00241 D00282 D00629 D00790 D01034
D01036 D03814 D00199 D00214 D00220 D00318 D00373 D00705 D00770 D00774 D00780
D00825 D00908 D00919 D00927 D00194 D00357 D00484 D00537 D00539 D00616 D00628
D00651 D00698 D00702 D00740 D00744 D00771 D00773 D00779 D00783 D00784 D00785
D00792 D00821 D00960 D00962 D01000 D01002 D01005 D01006 D01025 D01027 D03184
D03186 D03237 D03266 D03291 D03317 D03542 D03620 D03638 D03768 D03784 D01023
D01026 D01028 D01029 D03193 D00134 D00243 D00626 D00654 D00670 D00739 D00747
D00748 D03128 D03139 D03146 D03150 D03151 D03158 D03168 D03174 D03178 D03180
D03238 D03257 D03258 D03262 D03263 D03292 D03305 D03306 D03434 D03496 D03538
D03757 D03760 D03767 D00455 D00467 D03778 D00230 D00231 D00762 D00764 D00983
D01003 D01022 D03127 D03797 D03823 D03824 D00105 D00127 D00132 D00135 D00136
D00185 D00187 D00335 D00355 D00532 D00569 D00572 D00576 D00700 D00710 D00746
D00754 D00759 D00761 D00806 D00820 D00840 D00847 D00850 D00858 D00906 D00907
D00918 D00928 D00986 D01042 D01060 D01074 D01075 D03281 D03312 D03315 D03471
D03481 D03506 D03519 D03539 D03544 D03546 D03714 D03746 D00227 D00991 D00997
D03203 D03303 D00658 D00107 D00114 D00163 D00175 D00184 D00188 D00198 D00210
D00226 D00232 D00252 D00291 D00295 D00297 D00299 D00305 D00312 D00319 D00327
D00333 D00345 D00354 D00362 D00389 D00391 D00396 D00400 D00402 D00404 D00406
D00450 D00459 D00491 D00506 D00550 D00551 D00560 D00697 D00704 D00706 D00798
D00802 D00803 D00804 D00814 D00817 D00824 D00835 D00900 D00904 D00924 D00925
D00926 D00929 D00969 D03103 D03134 D03142 D03156 D03163 D03166 D03177 D03188
D03205 D03208 D03210 D03226 D03411 D03529 D03557 D03627 D03635 D03636 D03639
D03663 D03669 D03670 D03687 D03693 D03694 D03697 D03701 D03705 D03709 D03711
D03713 D03718 D03723 D03729 D03745 D03753 D03758 D03766 D03770 D03788 D03817
D00855 D01041 D00426 D00519 D00593 D00856 D00859 D03468 D03469, and D03869
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE
Healthcare,
Manufacturer: GE
Medical Systems, Kretziechnik GmbH & Co OHG, Zipf, Austria.
REASON
Inaccurate dimension
measurements in M-Mode when pan-Zoom is activated in GE Voluson® E8 Ultrasound
Systems. Of particular concern are potential inaccuracies of fetal cardiac
measurements that may impact patient safety.
VOLUME OF PRODUCT IN
COMMERCE 1,637 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM
Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800
Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative
determination of Acetaminophen concentration in human serum or plasma. CODE
Lot numbers: M703276 and
M702524
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Beckman Coulter, Inc., Brea, CA,
Manufacturer: Beckman Coulter, Inc., Fullerton, CA. REASON
Acetaminophen reagents (lots #M702524
& M703276) manufactured with contaminated heparin has shown a negative bias
in performance between the assay made with contaminated and uncontaminated
heparin.
VOLUME OF PRODUCT IN COMMERCE 7,764 set
kits
DISTRIBUTION Nationwide and Canada
PRODUCT
ACIST" BRACCO, AT P54 AngioTouch Kit, SKU # 014644, Sterile. Made in Mexico. Catalogue
No: 800608-013 intended to be used for the controlled infusion of radiopaque
contrast media for angiographic procedures,
CODE Lot numbers: 0368H, 0368J, 0378L, 0388F,
0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T,
0848K, 0848L, 0878M, and 0918N
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Acist Medical Systems, Eden
Prairie, MN,
Manufacturer: Nypro
Healthcare Baja, Tijuana, Mexico. REASON Some of the sterile package seals of AT P54
AngioTouch Kit were breached. Breached package seals could compromise product
sterility, which could potentially lead to patient infection.
VOLUME
OF PRODUCT IN COMMERCE 33,980
kits
DISTRIBUTION Nationwide, Canada, Brazil, Japan,
China, Korea, Thailand, Hong Kong, and Australia
PRODUCT
a)
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2
Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product
is shipped 20 units per carton. The product is used with the Horizon Pump,
Horizon NXT Pump, and Outlook Safety Infusion System,
b) Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System,
c) Safeline Metriset w/Cassette, inj sties, clamps LL 114
in. Item/Catalog number 375122. The product is shipped
20 units per carton. The product is used with the
Horizon Pump, Horizon NXT Pump, and Outlook Safety
Infusion System,
d) Metriset Burette Set w/Horizon
Pump, Ultrasites, 120 in. Item/Catalog number 375150.
The product is shipped 20 units per carton. The product is used with the
Horizon Pump, Horizon NXT Pump, and Outlook Safety
Infusion System,
e) Burette Set w/150 ml Burette
w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88
in US1540. Item/Catalog number 375137. The product is
shipped 20 units per carton. The product is for use
after activation of shutoff valve (re-floating of disk),
f) Add-On Burette Set with 150 ml burette and Ultrasite Injection Site
without automatic shutoff. Item/Catalog number 375111. The product is shipped 20
units per carton. The product is for use after activation of shutoff valve
(re-floating of disk),
g) Add-On Burette Set with
150 ml burette 7 Ultrasite Injection Site with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set.
Item/Catalog number 375059. The product is shipped 20
units per carton. The product is for use after activation of
shutoff valve (re-floating of disk),
h) Burette Set w/150 ml burette w/15 um filter & inj
site, inj site, with automatic shutoff 87 in.
Item/Catalog number 375113. The product is shipped 20 units per carton. The
product is for use after activation of shutoff valve (re-floating of disk),
CODE
a) Lot numbers 60999552 exp
4/30/2011, 00VL986720 exp 1/31/2013, 00VL986732 exp
1/31/2013, and 60999551 exp 3/31/2013;
b) Lot number 60998897 exp 3/31/2013;
c) Lot number 60998903 exp 3/31/2013;
d) Lot number 60998893 exp
3/31/2011;
e) Lot number 60999539 exp 3/31/2013;
f) Lot number 60999546
exp 3/31/2013;
g) Lot number 60999544 exp 3/31/2013;
h) Lot number
00VL987139 exp 12/31/2012
RECALLING
FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown,
PA, Manufacturer: B. Braun, Santo Domingosanto
Domingo, Dominican Republic.
REASON Incorrect burette was packaged with the
product.
VOLUME OF PRODUCT IN COMMERCE 29,180
units
DISTRIBUTION Nationwide
PRODUCT
Kwiktrak Gate System; the rail system used with the Maxi Sky 600
Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 -
Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box,
part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x
700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x
700.11560). The equipment is intended for transferring lifts from one system
track to another.
CODE Serial numbers: GA-1304-0001 to
GA-2608-1374, all units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL,
Manufacturer:
B.H.M. Medical, Inc., Magog,
Canada. REASON There
is a possibility that the Kwiktrak Gate System could malfunction, resulting in
the gate locks opening even though the corresponding tracks are not properly
aligned.
VOLUME OF PRODUCT IN COMMERCE 230
units
DISTRIBUTION Nationwide
PRODUCT
a) Innova 2000; The principle system components include a C-arm,
image acquisition, processing and archiving capabilities. Indicated for use in
generating fluoroscopic images of human anatomy for vascular angiography,
diagnostic and interventional procedures, and optionally, rotational imaging
procedures. Also indicated for generating fluoroscopic images of human anatomy
for cardiology, diagnostic, and interventional procedures. Intended to replace
fluoroscopic images obtained through image intensifier technology,
b) Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology,
c) Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare,
Waukesha, WI 53188 (The system consists of an a monoplane Indicated for use in
generating fluoroscopic images of human anatomy for vascular angiography,
diagnostic and interventional procedures, and optionally, rotational imaging
procedures. Also indicated for generating fluoroscopic images of human anatomy
for cardiology, diagnostic, and interventional procedures. Intended to replace
fluoroscopic images obtained through image intensifier technology,
d) Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188
(The system consists of an a monoplane positioner, a vascular or cardiac table,
an X-ray system and a digital detector) Indicated for use in generating
fluoroscopic images of human anatomy for vascular angiography, diagnostic and
interventional procedures, and optionally, rotational imaging procedures. Also
indicated for generating fluoroscopic images of human anatomy for cardiology,
diagnostic, and interventional procedures. Intended to replace fluoroscopic
images obtained through image intensifier technology,
CODE
a) Lot numbers: 201996LAB2 201996LAB3
202745VACATH2 203576NI1 205783BCL3 205783BCL4 206598INNOVA1 207626CL1 207755CL1
207795CL1 207795CL2 207871CL6 208381INNOVA 208523CATH 209526ICATH1 210292CATH1
210297NECATH1 212746J412 213726CATH 213977INNOVA1 213977INNOVA4 214320INNOVA
214590INNOVA 214820INNOVA3 214820INNOVA4 214947CMINNOVA 215448INNOVA
215728INNOVA 215861LC2 216778LABA 217258CATH 217383CCL3A 217464INNOVA 219465CL1
219465EP 219757INVA 219932DCL1 219947EP 228INNOVA 229259INOV1 229259INOV2
229386INOV1 239436CATH2 239939CLB 251435ICV1 251435ICV4 252443NGIN1
253627INNOVA2 253627INNOVA3 254519I2K 256341IN1 256386IN1 256880IN1
262243INNOVA1 262255INNOVA1 262569INNOVA 281338INA 281351TINNOVA 281440LAB2
281440LAB3 281540NECATH 281893INNOVA 301891CATH1 302421INNOVA 303320CL1
303320CL2 303369CL2 303425HCL1 303673CL1 303715CL1 303730CL1 303778CL1 303778CL2
305223IN1 305223IN2 305325CCL3 305325CL4 305585CL2 305585CL3 308865PHI
309454BINNOVA 309691HCL1 309691PINNOVA 310423INNOVA3 310423INNOVA4 310423INNOVA5
310423INNOVA7 310540INNOVA 312792RINOV2 313343LC 314569JC1 314966DCL2A 315448RM1
315448RM2 315448RM3 316268INNOVAB 316268INNOVAEP 316689INNOVA1 317621EP2
317621INNOVA1 317621INNOVA2 317621INNOVA3 317818MDI915 317887INNOVA1
317887INNOVA2 318448INNOVA 318449INNOVA1 321HCL4 321HCL5 321PBCL1 330375LAB1
330837INNOVA 336716BCL1 336832MCCL1 336832MCCL3 337289INNOVA 352344CATH1
352INVCATH 361788NOVA 386719CATH 401274IN3 402280CIN1 402280CIN2 404265AMC2
404305SF1 404686CRI1 404686CRI2 404712EI1 405272SCL4 407321INCL1 407518CL1
407518OPCL 408259INV 410337INNOVA1 410337INNOVA3 410337INNOVA4 410337INNOVA5
410543CATH1 410543CATH6 410614CV7 412232B 412367LAB1 412367LAB3 412623LABB
412623LABC 412623LABI 412647LABA 412647LABB 412647LABC 412647LABD 412784C1
413748INNOVA 414219INNOVA 414291CL3 414649INNOVA 414805INNOVA2 414961INNOVA
415206CATH 415750SCL1 415750SCL2 416284INNOVA 416469INNOVA 417269SCLB 417269SCLC
417885JCL1 417885JCL2 417885JCL3 417885JCL4 418656CNOVA1 418656CNOVA2 419227CL3
419526INNOVA3 419526INNOVA4 423493PCL3 423495CHIRM1 423559BCL1 423844CCL2
440835INNOVA 443481INOVA1 443849INNOVA 478765CTH1 478765CTH2 480512IN1 480512IN3
480728LAB1 480821IN1 501484LC3 501686UAINNOVA 502587L2 502587LAB3 502587LAB5
503215INNOVA 503370INNOVA 504391INNOVA 504447INNOVA 504903INNOVA 505983CATH
508798INC2 508856IN3 508856IN4 508856IN5 508856IN6 509473DR5 509473DR6 509473DR7
509946CATH1 512341RI 512447SI 512447SI2 513559INNOVA 513853INNOVA 513861INNOVA
514376CARDIO 514468BINNOVA 514843AINNOVA 516562INNOVA3 516562INNOVA5 516663EP3
516663INNOVA1 518243EP1 518525LAB2 519663INNOVA 520296CATH1 530244XC3
540932INNOVA 541282CV1 541382CV1 541382CV2 541686SPR3 561548CL1 561548CL2
561548EP 561798CATH1 561798CL1 562491INNOVA 563244CATHLAB1 563244CATHLAB2
563421CATHLAB1 563421CATHLAB2 563421CATHLAB4 563421CATHLAB7 570969CATH
573472CATH 573632CRC1 573686CL1 573761SMC1 601268INNOVA1 601553CL1 601553CL2
601968INNOVA 602239LAB1 602588INNOVA 603228CCL2 603433PLC1 603650CATH3
603668CLCB 604682INNOVA 605719INNOVA1 605719INNOVA2 606439INNOVA 608324CATH
609267INNOVA 609652CATH2 609653INNOVA 609757IN2000 610270INNOVA 610431CL1
610431CL2 610447CL2 610645CL5 610648INNOVA 610954INNOVA 610954INNOVA2
610988INNOVA1 610988INNOVA2 610988INNOVA3 612273INNOVA1 612467INNOVA1
613548INNOVA2 614293INNOVA1 614293INNOVA2 614293INNOVA3 615222STCL3 615222STCL5
615284CV2 615316INOV2 615327CV1 615327CV2 615495MCL5 615768CV1 617754IN1
617754IN2 617754IN3 617754IN4 618241GSI 619260INNOVA 619340VA7 619457INNOVA3
619691INNOVA 619739INNOVA 623848LAB1 626915INNOVA 631376INNOVA 636916SPCL1
636947JCL3 650696INV1 650723SC6 651582INN1 661949INNOVA 701234GE2 701234GE3
701857I2K 702388INNOVA1 702564INNOVA 702731INNOVA 702731INNOVA2 702731INNOVA3
704487CMIN1 706651CCL 706721CCL 706774CCL2 706774UC6 707546INNOVA 708202VA2K
708333INOVA 708352L2K 708425INNOVA1 708597EP 713359INA 713359INB 713776MINNOVA
713794LAB10 713794LAB3 713794LAB4 713897CIN 713964BIN 714229INNOVA 714533INNOVA
714953INNOVA 714999INNOVA 716859BGEP 717270INNOVA1 717270INNOVA2 717544CATH1
717544CATH4 717763INNOVA 717763INNOVA2 717782INNOVA 718226INNOVA1 718226INNOVA2
718283INNOVA1 718283INNOVA2 718780CATH1 718918CATH1 718963INNOVA1 719560HCL2
719776CL1 719776CL2 720225CL1 724284CL 724773C2 724773C3 727521CATH3 727725CATH1
727825CATH 727869CATH1 732557INNOVA 732776CATH1 732776CATH5 740439CATH
740454INNOVA1 740454INNOVA2 757886CATH1 760633INNOVA 760940INNOVA1 770228GC1
770991INNOVA 773702INNOVA 773878SWGCATH1 773878SWGCATH2 773878WCL 773884HC2000
773STJINNOVA200 775770CATH1 775982CATH3 785354HRT1 785354HRT2 801299INNOVA
801373CATH1 801373CATH2 801373EP 801429INNOVA 801479INNOVA 803256CL6 803256PCL3
803256PEP1 803256PEP3 803329CL20 803641CCL 804285CATH4 804320CATH1A 804320CATH3A
804320CATH5 804320CATH6 804764INNOVA 805497INNOVA1 805497INNOVA2 806354INNOVA1
806354INNOVA2 808242INNOVA 812265L1 812283IN20 812376CL1 812450CATH2 813615CL2
814534C1 814765CATH 815226INN1 816932HRT2 816932SLHEART8 816985NKCI2
817255NH2000 817329BGINNOVA 817347MPINNOVA 817465ARINNOVA 817877INNOVA
817922INNOVA 818502INNOVA1 819563CINNOVA1 819563CINNOVA2 828262CL 828298CCL
828322FIN 831462CL1 831624INV1 832355SMIN 843339INNOVA 843577CL1 843674INNOVA
843692INNO 850325INNOVA1 850325INNOVA2 850494INNOVA 850494INNOVA2 850862INNOVA1
850862INNOVA2 856342INNOVA 859233INNOVA1 859233INNOVA2 859276INNOVA 859313CL6
859313CL7 860210CV 860358CV 861EP2 864261CL1 864261CL2 864455GMIN1 864455GMIN2
865218CCL1 865481CCL1 865541CCL1 865541CCL2 865541CCL4 865693CCL5 870508LAB3
901384CV3 901726R2 901757CV2 901765CV1 903315INN 903798WINN 903870INN
904202CATH1 904202CATH2 905895INNOVA1 905895INNOVA2 905895INNOVA3 908668INNOVA
909865INNOVA1 909865INNOVA2 909CH2000 910343NHIN2 913317SLSHEART1 913791OINCATH
918307SHIN1 918307SHIN2 918341CI 918494IN2A 918744JI1 918744JI2 918744JI3
919934JCL 920288CATH1 920288CATH2 920729INNOVA 920738INNOVA 920926CATH1
928639IN1 936266CL2 936539CL2 937208INNOVA1 940384INNOVA2 940764INOV1
940764INOV2 940764INOV3 940898INN 941483INNOVA1 941483INNOVA2 949753INNOVA
952993INNOVA 952993INNOVA3 952993INNOVA4 956389INNOVA 956632INOVA 970350CL3
972335INN 972394INNOVA 972540INN 972969INNOVA 973365CATH 973365LAB1 973971EP2
973971LAB1 973971LAB2 973971LAB4 973971LAB5 973972LAB1 973972LAB2 973972LAB3
985867INNOVA1 985882INNOVA AL9INNOVAVAN CSI214 DR2000 DUCK ECXV1401A ECXV1406C
FHORLCL2 FHORLCL4 FHORLCL5 FHORLCL6 FHVIN2000 FLGRCATH1 FLGRCATH2 FWCL3772
KMCINNOVA LIJ016133 LVEPINOV5 LVINOV1 LVINOV2 LVINOV3 MCTH072 MCTHSC1 MCTHSC2
MOUSE WCATHLAB2000 2548244 2577797 2590608 0002733004A 920020937 0920020937A
0920020937B 202745GEMNET 262548INNOVA 604875INNGEC 631968EP1 843577CL1GP, and
ECXV1407I;
b) Lot numbers: 201447LAB1 202782LABC 2035762100 208227CATH1
208367INNOVA 208381CCL1 212305CATH1 212604INNOVA1 214947MINNOVA 214947MINNOVA2
215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3
251435ICV7 252384CATH1 253627INNOVA1 262255INNOVA2 262687CL2 303369HCL4
303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1
310825INNOVA21 317355INNOVA3 318448INNOVA3 330363LAB3 330375LAB2 336538ARCL
336832MCCL6 360456XCL4 402559UCC 402559UCD 405604D2100 408559INV1 409938INV21
410337INNOVA6 410554INNOVA1 410554INNOVA2 410554INNOVA3 410554INNOVA4 4107872100
412367LAB2 414291CL2 414649INNOVA2 416480INNOVA 416864INNOVA 416864INNOVA2
417269SCLA 417347FCV2 417347FCV4 423495MCATH1 4436432100 501257VALAB1
505848CATH1 505848EP 508335INNOVA 508856IN21 508941IN21 509575YM2100
516562INNOVA2A 516562INNOVA6 516562INNOVA7 516632INNOVA1 518243LAB1 518243LAB2
541732CV2 541743CL3 561548ET2 570476INNOVA21 573256MHC 573761SMC2 573815BCR2
573815BCR3 573815BCR4 574535IN21 602239CLAB2 604682INNOVA1 604682INNOVA2
604875AINNOVA1 604875AINNOVA2 607737CL1 608775NOVA1 608775NOVA2 610250INNOVA1
610250INNOVA3 610776INNOVA21 610983INNOVA2 612273INNOVA2 615284CV3 615342CV3
615446CV1 615515OPCL 617636CL1 619457INNOVA6 619552INNOVA2 630856H2100 650369SV4
65049321 651582IN3 661327INNOVA1 661327INNOVA2 7023602100 704384CL21 706291CLIN1
713375U2100 713794LAB1 717217INN21 717544GECATH2 717544GECATH3 718470EP
718780CATH3 727521CATH2 727521CATHOP 727869CATH3 727869CCL2 727869EP5
727942CATH2 732324INN1 732776CATH4 732923INN 770HMCCL1 775982INN2100 781340IN1
781340IN3 785354HRTEP 803256PCL5 804764CATH2 8053702100 808547QCV1A 808547QCV3A
812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 8157412100
815759CARDIAC1 816861KCVAI2 817329BG2100 8184092100 828213IN21 843692CATH3
843724CL1 843724CL2 843724CL3 843724EP1 843797EP 843797TCL1 845365V13 845368LAB1
845368LAB2 847316INNOVA1 847316INNOVA2 856853IN2100 857307IN421 858554INNOVA2
858554INNOVA3 864255SFCL1 864255SFCL2 865693CCL 865693CCL2 865977CCL 901765EP
904597CATH 905848INNOVA1 910343EP1 910343EP2 910671INOV21 916781INNOVA2
9284532100 937208INNOVA2 949250I21 954735CL2 954987CCL7 954987CCL8 954987CL4
970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F
FHOMEP LVINOV7 PRESBYDEP RPINNOVA2100 2637041 2680771 2683172 2686112 2706718
2710562 2713664 2713687 2715023 2718602 2729712 2730402 2730405 2730406 2731313
2731570 2731573 2731583 2738012 2741780 2749861 2754702 2755150 2756171
262687CL1 316689MP 541677MINNOVA2 541789CV1 609267IN2100 609757IN2100
610645LAB10 760940INNOVA2, and 828315FIN2;
c) Lot numbers: 2652143
2014183100 201541LAB2 201996LAB1 2035763100 2035763100A 2036883100 205783BCL5
205877CCL1 205877CCL2 207351YCL1 207662CL4 207879CL131 208227CATH2
209334LINNOVA1 214324INNOVA2 214590PH3100 215335INNOVA1 215576INNOVA1 219326IN31
2197573100 219877IN2 219877IN31 228818VASC 239436CATH3 239513CRLAB1 239939CLA
251435ICV6 251633PROV 253968INNOVA 254742KDCL1 262687CL3 270688INN 281420LAB1
281420LAB23100 281440CL3 3027443100 303425CL4 303629CL4 303629EP 303788CL2
305364P3100 308865GIN2 309691P3100 310319SM3100 310423INNOVA1 310825INNOVA31
312STMNAZ3100 313593IC1 313593IC2 314525STACL2 314768SMCL1A 314768SMCL3
316268INNOVAA 316651INNOVA31 316962WCVC1 316962WCVC2 318448INNOVA2 318449INNOVA2
318798CL1 325428CATH1 325428CATH3 334418CL 336832MCPV 337374INNOVA 352333CATH1
352333CATH2 360456XCL3 361857CATH1 361980INNOVA2 402559UCB 404686CRI3 405272SCL2
405372S3100 405604D3100 405610NW3100 405840OIC3100 406447VAIN3 406543IN3
409899LAB3 4103323100 4103623100 412437INNOVA 413447CATH 413540IN1 413582C3100
414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417269SCLD
417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 479441SP3100
480728LAB2 480821IN2 502587LAB1 502587LAB4 502852INNOVA 5033703100 5034353100
507385INN3100 508856IN2 508941IN1 509946CATH2 510797INV8 512901NI3100
516562INNOVA8 516562INNOVA9 516632INNOVA2 516663INNOVA1A 516663INNOVA2
518525LAB1 530244XC106 540953INNOVA 541382CV3 541677MINNOVA1 541743CL6
541MWHINNOVA 561266IN31 561548CL4 570476INNOVA31 573458CL1 573632CRC2 573815BCR1
573882UMC1 580548B3100 6012883100CV2 601553CL3 601883CL1 602239LAB4 602239LAB6
602266LAB2 603421PCL 603580ECL1 608524NOVA 609757IN3100 610447CL1 610526LAB1
610526LAB2 610595CL1 6106483100 610770INNOVA31 610891CL1 610954INNOVA1
610983INNOVA1 615338CV2 615769SKYCV2 616392INNOVA 617732IN9 617789IN1
618241GSI3100 619340VA8 619457INNOVA5 619482INNOVA1 619541INNOVA31 619552INNOVA1
620225INNOVA31 630312B31 630856H31 631376EP 631968INNOVA2 631968INNOVA3
650369SV3 65049331 6619483100 662377CV2 662377CV4 671GMHAINVA 678957INNOVA
7018573100 7022333100 702616INNOVA 7028533100 7028803100A 704355RM2 704384CATH2
704384PHMCATH 704878CL31 706481CCL 706774CCL4 706774CCL5 7083333100
708WESTSUB3100 713359INC 713776M3100 713794LAB7 713794LAB9 713948INA
714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31A
717782INNOVA31B 718245UNITY 718250CATH1 718270INNOVA1 718283INNOVA3
718470INNOVA2 718780CATH2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV
732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1
770991CL3 772LWCL1 773792CL3100 773NORWG3100 775982CATH2 781340IN2 785354S3100
8014793100 8019643100 803255CL1 803256PCL1 803329CL31 804285CATH1 8053703100
808547QCV2A 812238LIB1 812283IN31 812450CATH1 812450EP1 812482INNOVA
812858GWLAB1 812858GWLAB2 814676C1 815226INN2 815344CARDIAC3 815599FHN3100
8157413100 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816969LSCATH
816985NKCI 817433HSW3100 8184093100 8185023100 8189813100 843797TCL2 845365V19
847362CONCATH4 850469BCV1 850678IN3100 850747BR3100 850747GC3100 850862IN3100
856596IN3100 8613100 863687CL31 864255SFCL3 865481CCL2 865512CL3 865693CCL1
901516R3 903UT3100 904202CATH3 904276CTH1 907562CATH1 908522LAB1 909464IN3
909788INNOVA1 909825VAINNOVA 910343NHIN4 912486CATH1 913345MI1 916781INNOVA1
918333JPIN1 918333JPIN2 918494IN31A 919731WMINOV 919784REP1 9202623100
925779INNOVA408 928779INNOVA1 931459CV1 936266CL1 940626DCH3100 941798CLAB2
951788INNOVA2 951788INNOVA3 952993INNOVA5 954987CCL9 956389INN31 956698INN31
956994INN1 956994INN2 970350CL1 970945CL1 9734293100 973877LAB4 973971LAB3
BPINNOVA1 BPINNOVA2 BPINNOVA3R DR3100 ECXV1406B FHORLCL1 FHORLCL7 LVINOV4
MARTINSVILLE310 MCDCATH2 2575081 2601648 2610213 2625271 2638199 2652070 2656470
2661770 2680614 2681424 2682930 2686429 2698717 2699058 2713223 2713498 2713501
2713606 2716215 2724811 2725165 2727031 2728632 2729012 2729039 2730996 2731216
2731616 2732637 2739644 2741814 2742714 2745812 2745843 2745917 2749863 2750261
2751926 2752431 2753571 2753701 2754912 2754940 2754953 2754989 2755128
443481LCV 504447INNOVA2 580421V3100 609267IN3100 609597IN3100 610645LAB6
732776CATH2, and 909CH3100;
d) Lot numbers: 201541SP1 2035764100
204787INNOVA1 205759CL2 209467INNOVA308 216844INNOVA 219326IN41 2194654100
229228INNOV41C 229228INNOV41V 22925941V 22925941V2 229434INNOV 239436CATH1
239939INNOVA 248849SP1 250370INNOVA 251435I12 251435ICV5 252816INNOVA 252847PRS2
252847PRS3 269226IN1 269226IN2 269983IN41 281401T4100 3016094100 3018774100
3027444100 303320OR41 303399IR 303436ANGIO 303839CL1 304255INNOVA 304256INNOVA
304347INNOVA 304347INNOVA2 304424CCINOVA 305823IN4100 305835IN41 306766INNOVA
308534ANG 309343CSP1A 309655FSP1A 309655FSP3A 309672M4100 312792R4100 313343SP1
313876SP41 314569SJRM12 314966DPHSP 315448RM4 315448RM5 316651INNOVA41
316962INNOVA41 317338PV3 317887INNOVAPV 3184734100 319338VA4100 325670CATH
330489SPEC9 334286BSP 337981INNOVA 352333INVOR 352333VASC 352376SP 352401CATH
352401VASC 352596SPEC 360754INNOVA 386254HS1 386254HS2 386HPOS1 401274IN41
404466SF41A 404616INNOVA 404GHSIR1 404GHSIR2 407518SP2 407518SP3 407SPECIALS
4082594100 409212INOV41 4103374100 410337INNOVA2 4105434100 412623LAB1
412623LAB3 412647OR10 412784LAB1 412784LAB2 4134474100 4135344100 4137484100
414328INN4100 414649CL2 414649DVI 414961INN4100 4163694100 416756INNOVA
419251LAB1 419557ORLAB 419696LAB1 423493I4100 423495ENDO2 423495M4100E
423495MSPEC2 4438494100 478633INOV 478765ANG1 480512SP 5033704100 505848CATH2
505848V4100 508383IN4100 508650IN41 508856OR41 5094744100 509474SH41 509482HFI
509575YM4100 512528CPCL1 512901NI4100 5134754100 5135844100 5136864100
5138534100 514376INNOVA 514842AINNOVA 514934BANGIO 515263IL4100 516562INNOVA4
519663INNOVA2 519685INNOVA 530888ANG206 541282CV2 541686SPR1 5417684100
561548VAS2 561694IN1 561747IN4 561776IN41 561784INSP 5703214100 570321LAB2
5705224100 573632CRA 573761SMA 574294IN41 574535IN41 574647IN2 574647IN41
586573SP1 6012884100SP1 601376SP4100 6029234100 603650ANG1 604557INNOVA
605333RM10 606833INNOVA 6082634100 608263ACT 608263XMR 608324DAL 609652CATH3
610954INNOVA41 610988INNOVA4 613548INNOVA3 614293LIBERTY1 614293LIBERTY2
615284OR15 617525IN1 617636IN1 617726RF2Y6 618549CM4100 619229INNOVA1
620665INNOVA41 623848SP 626359INNOVA 630275G41 630275G41B 6309784100 650369SV5
650493ANGIOCT 6616324100 662244GTSP 678EJCIR1 7023604100 7028804100 704487CR41
706278INNOVA1 706291RINN 706291RINN2 706651SP1 706733SP1 706774USP3 706802FINN
708202VA41 7087564100 708783CL4100 708783SP4100 708WESTSUB4100 713375U4100
7137764100 715369INN4100 717763INNOVA41 717763OR4100 718206LIBERTY1 718250ANGIO
718518CVL1 718630LIBERTY 719560INN41 724656ANG 727398SPEC1 727725SPEC1
727791INNOVA 727819SPSC 740592INNOVA 757398INNOVA 757736INNOVA 757889INNOVA
760633IR1 770535N4100 770736SP1 773878SWGANGIO1 77573841 801268INNOVA 80140841
8014794100 80158241 80180741 802295VALCA 803256SP 803329CL41 804285CATH2
804320CATH2B 804594ANGIO 804594CATH 804764CATH3 810342A41 812238UN41
812279INNOVA1 812825INNOVA1 812858GWSP 813558INTV 813615CL10 813745INTV
813972INTV 815740SC4100 8159374100 816276SP1 816943SP1 817255NH4100
817433HSW4100 817465AR4100 817922BA4100 828298VASC 828696IN41 843577CL2
843674VAS1 843797TIR2 845368RM10 8458584100 847842GS4100 850494WSP1 850747IN4100
856365ANGIO 8593134100 8595724100 863687INV24 864255SF4100 864573LAB2 865373SP
865481SUR 865541CCL5 865693CCL3 901726SP2 903CSM4100 903GS4100 904202SP1
904276SP 904BSSP 908522SP1 913317SLS4100 915577SP1 918307SHIN4 918682IN41
918744JC4100 918744JR4100 9408984100 941483INNOVA41 952993INNOVA2 954MW4100
956632INN4100 970247INNOVA 972335LIB 972487ANGIO1 972566INNOVA3 985867INNOVA2
989466INNOVA COR359867 DR4100 ECXV1406E ECXVINNOVARST3 FHORL4100 FWANG3217
MCL4100 MIRAMAR41 PEMBROKE4100 RADNETXV1 RADNETXV2 RHD4100 SLIN4100 WCATHLAB41
2515139 0002520549A 2574392 2650620 2667650 2670537 2677299 2680596 2683976
2697900 2698692 2701519 2705539 2710199 2712110 2712111 2713221 2718141 2722283
2729637 2730844 2733412 2733723 2740431 2741400 2741459 2741764 2742712 2742719
2743706 2744276 2744293 2744745 2745129 2745685 2745844 2746655 2750142 2750583
2753604 2754920 2756873 2757398 256429SV1 317621PV 318681INNOVA1 6012884100SUR
609757IN4100 731541XA1 904202SP2 906485ANGIO ECXVINNOVARST1 ECXVINNOVARST2, and
ECXVINNOVARST4
RECALLING FIRM/MANUFACTURER
Recalling
Firm: GE Healthcare, Waukesha, WI,
Manufacturer:
GE Medical Systems, SCS, Buc Cedex, France.
REASON The charger and/or battery of the PDB may
fail earlier than expected with no advance warning and thus cause the system to
shut down.
VOLUME OF PRODUCT IN COMMERCE 1,573
units
DISTRIBUTION Nationwide and
Guam
PRODUCT
a)
500 mL InfoV.A.C. Canisters (with Gel); 1) Part #M8275063/5 (5 canister pack)
and 2) Part #M8275063/10 (10 canister pack); products are single use and labeled
as STERILE,
b) 500 mL InfoV.A.C. Canister (without
Gel); 1) Part #M8275071/5 (5 canister pack) and 2) Part #M8275071/10 (10
canister pack); products are single use and labeled as STERILE,
CODE
a) 1) 20064392, 20069119, 20069125,
20069126, 20069279, 20069279.18308F, 20075082, and 20079173; 2) 20046268,
20046268.18908A, 20046270, 20063933, 20064393, 20064394, 20064395, 20064753,
20064753.14408B, 20067300, 20067300.14408B, 20067301, 20067302, 20067303,
20067304, 20067305, 20069120, 20069121, 20069273, 20069273.14408B; 20069274,
20069275, 20069275.18908A, 20069277, 20069277.18908A, 20069278, 20069278.18908A,
20069280, 20075084, 20075085, 20075086, 20075262, 20075263, 20075264, 20075265,
20075266, 20075268, 20075269, 20079174, 20079175, 20079176, 20079177, 20079178,
20079179, 20079180, 20079181, 20079182, 20079183, 20079184, 20079185, 20079186,
20079187, 20079188, 20089680, 20089681, 20089682, 20089712, 20089713, 20089749,
20089750, 20093372, 20093374, and 20094200;
b) 1) 20063928; 2) 20062500, 20063927, 20063927.15108D, 20063930,
20063930.15108D, 20067296, 20067297, 20067298, 20069122, 20069123,
20069123.15108D, 20069124, 20069124.15108D, 20069276, 20071227, 20073941,
20075083, 20075267, 20079189, 20079190, 20079191, 20089714, and
20094198
RECALLING FIRM/MANUFACTURER
Recalling Firm: KCI
USA, Inc., San Antonio, TX,
Manufacturer:
Avail State College, Bellefonte, PA.
REASON The port on the 500mL
InfoV.A.C. Canister
that connects to the suction pump tubing was found to be partially or fully
occluded with plastic.
VOLUME OF PRODUCT IN
COMMERCE 229,400
canisters
DISTRIBUTION Nationwide, Austria, Belgium,
Denmark, France, Germany, Netherlands, Sweden, and the UK
PRODUCT MONARCH®
II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in
pouches, 10 pouches/carton, and labeled in part ***for AcrySof® IOLs*** The
product is used for implanting intraocular lenses (IOLs) into the eye following
cataract removal. Each cartridge is imprinted with the model type on the wing of
the Monarch II cartridge which can be visually verified prior to use,
CODE
Lot 174249 Exp 07/2010 Lot 174250 Exp
07/2010 and Lot 174244 Exp 07/2010
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Alcon Laboratories, Inc., Fort
Worth, TX,
Manufacturer: Alcon Manufacturing
Ltd., Huntington, WV.
REASON Delivery cartridge for implanting
intraocular lenses is mislabeled and may result in complicated insertion and
damage to the lens.
VOLUME OF PRODUCT IN COMMERCE 7,962
units
DISTRIBUTION Nationwide, Brazil, Canada, Chile,
Hong Kong, Singapore and India
PRODUCT
a)
SERVO-i Ventilator System. The product is intended for treatment and monitoring
of patients in the range of neonates, infants and adults with respiratory
failure or respiratory insufficiency. Article number 64 87 800,
b) SERVO-s Ventilator System. The product is intended
for treatment and monitoring of patients in the range of neonates, infants and
adults with respiratory failure or respiratory insufficiency. Article Number:
66-40-440, CODE
a) Serial numbers:
34034, 34035, 34050, 34052, 34053, 34054, 34058, 34060 through 34083, 34085,
34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295,
34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230,
34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360,
34376, 34384, 34390, 34427, 34490, and 34530;
b) Serial numbers: 7591, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7613
through 7666, 7676, 7677, 7678, 7879, 7680, 7681, 7682, 7686 through 7703, 7709
through 7724, 7737, 7740, 7745, 7749, 7750, 7758, 7759, 7760, 7763, 7764, 7770,
7771, 7772, 7775, 7776, 7777, 7778, 7779, 7800 through 7825
RECALLING
FIRM/MANUFACTURER
Recalling Firm: MAQUET Inc., Bridgewater, NJ,
Manufacturer: Maquet Critical Care AB,
Solna,
Sweden. REASON Maquet
became aware of potentially defective crimpings at the point connector attached
to the cable in SERVO-i and SERVO-s ventilators.
VOLUME OF PRODUCT IN
COMMERCE 404 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
Quicklock Tracker, Size 2; ref: 111.100. Device is a surgical
instrument,
CODE Lot numbers:
PC040050, PC030403, PC040292, PC040293, PC050034, PC050129 and
PC050034-1
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Zimmer, Inc., Warsaw, IN,
Manufacturer: Orthosoft, Inc., Montreal, Quebec, Canada.
REASON
The three-point array may
break during use, resulting in surgical delay and an increased risk of
infection.
VOLUME OF PRODUCT IN COMMERCE 239
units
DISTRIBUTION Nationwide
PRODUCT
NicoletOne 5.30.2 Software when used with CSeries amplifiers in
Fixed Room LTM Configurations with patient room kits. The product is used for
extended monitoring of EEG in a hospital setting. The system provides connection
between the patient room EEG acquisition system and central control room,
CODE
Lot numbers: PB070799 PB060399
PB060413 PB080901 PB070523 PBO80944 PB060414 PB060333 PB070817 PB070677 PB070669
PB PB060478 PB060207 PB080873 PB060234 PB060346 PB070605 PB060370 PB060461
OA040136R PB070844 PB070684 PB060421 PB060384 PB080890 PB060306 PB070837
PB070649 PB070638 OA050455 PB060192 PB070788 PB070746 PB060500 PB060227 PB070533
PB080999 PB060291 PB050140 PB070853 PB070673 PB070733 PB080980 PB070852 PB060511
PB060510 PB060383 PB060342 PB060502 PB080948 PB060465 PB060362 PB080995 OA050421
PB070749 PB070571 PB070718 PB080878 PB070861 PB060338 PB060353 PB070606 PB060386
PB050153 PB080953 OJ060318 OA040179R OJ060389 OJ060393 OJ060388 OJ060378
OJ060437 OJ060434 OJ060435 OJ060432 OJ060433 OJ070476 OJ070477 OJ070464 OJ070462
OJ070465 OJ070466 OJ070463 OJ070461 OJ070455 OJ070460 OJ070459 OJ070458 OJ070457
OJ070456 OJ070478 OJ070505 OJ070510 OJ070535 OJ070534 OJ070532 OJ070533 OJ070531
OJ070530 OJ070446 PB070591 PB070590 PB070754 PB070753 PB070765 PB070767 PB070766
PB070770 PB070771 PB070772 PB060191 PB070769 PB080924 OJ070498 OJ070489 OJ070527
OJ080542 OJ080555 OJ060314 OJ060341 OJ070479 OJ080548 OJ080554 OJ080553 OJ080560
OJ080581 OJ080559 OJ060321 OJ060320 OJ060323 OJ060322 OJ060324 OJ060325 OJ060327
OJ060328 OJ060326 PB060393 PB060469 PB070579 PB070582 PB070583 PB070580 PB070581
PB070578 PB070593 PB070665 and PB070820
RECALLING
FIRM/MANUFACTURER Cardinal Health NeuroCare Division, Madison, WI,.
REASON
NicoletOne 5.30.2 Software when used with
CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The
3rd party room relay connected to the A2 wall plate does not always activate if
the patient event button connected to the CSeries Amplifier is pressed twice
within one second.
VOLUME OF PRODUCT IN COMMERCE 274
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is
an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). Catalog
#12-658,
CODE Lot
#066T28
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Cholestech Corp., Hayward, CA,
Manufacturer:
Provalis Diagnostics Limited, Deeside, Flintshire CH5 2NU, UK.
REASON
Stability data
indicated that the product would not meet performance claims through the end of
its shelf life.
VOLUME OF PRODUCT IN COMMERCE 9,324
cartridges
DISTRIBUTION Nationwide, India, Slovenia,
Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
PRODUCT
Quick
Connect component p/n 201048. The component is contained in: a) QPC1713 and b)
QPC1724 Quick Connects. The QPC1724 is used to attach Pentax
70/70K/72/72K/80K/81K/90i/90K Series GI Endoscopes with Water Jet to the C1160
Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System.
The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES
without Water Jet to the C1160 Universal Flexible Processing Tray in the SYSTEM
1 Sterile Processing System,
CODE
a)
Serial #: 3870300, 3870367, 3870326, 3870342, 3923281, 3954195, 4008389,
4045720, 4091419, 4153292, 4201828, 4274429, 4297354, 4247052, C601846, C601879,
4569117, 4710430, 4770715, 4862314, 4899068, 4942173, 5005517, 5098421, and
5261433;
b) Serial # 3500782, 3531266, 3614856, 3644010, 3681319, 3753928,
3753944, 3754231, 3864709, 3865110, 3879319, 3935418, 3962214, 3967825, 4054979,
4123873, 4186201, C601848, 4274445, 4363339, 4247078, 4479853, 4588679, 4632667,
4684007, 4738753, 4802294, 4810867, 4869749, 4899084, 4942199, 4952487, 4987020,
5026513, 5063789, 5098447, 5159215, 5211669, 5256367, and
5257266
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Steris Corp., Mentor, OH,
Manufacturer:
Steris Corp., Hopkins Facility, Mentor, OH.
REASON During ongoing product development
testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4
are in a position to face one direction, the top Barlock may interfere with the
top surface of bottom barb of the adapter. The interference may cause the
plunger on the suction side to lift slightly which may affect flow of sterilant
into the suction lumen.
VOLUME OF PRODUCT IN COMMERCE a)
108 units; b) 557 units
DISTRIBUTION Nationwide, Canada,
Australia, Italy, Spain, and Thailand
PRODUCT Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic
conventional and mammography images on transparent film for viewing on a
standard view box. It may be used in any situation in which a hard copy of an
image generated by a medical imaging device is required or desirable. ID number
EYZ4E,
CODE
Serial numbers: 1024 to
1189; but excluding 1053, 1057, 1089, 1096, 1097, 1098, 1101, 1103, 1161, 1166,
1173, 1176, 1177, 1178, 1180, 1181, 1185, 1186, 1187 and
1188
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA
Corp., Greenville, SC,
Manufacturer:
Agfa-Gevart NV, Mortsel, Belgium.
REASON The "Film Calibration" setting on the printers
was set to the default "OFF" position instead of "ON".
VOLUME OF
PRODUCT IN COMMERCE 33
units
DISTRIBUTION Nationwide and
Canada
PRODUCT NobelReplace Tapered Groovy RP 4.3x10mm. These products are
root-form endosseous implants intended to be surgically placed in the bone of
the upper or lower jaw arches to support for prosthetic devices. Ref 32216,
CODE
Lot number:
403504
RECALLING FIRM/MANUFACTURER Nobel Biocare USA, LLC, Yorba Linda, CA,
REASON
The
NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect
cap label. The affected lot has a cap label identifying the implant as "4.3x8".
Since this cap label may be the only means used for identifying the implant
prior to surgery, it is possible that a user would try to use the 10mm implant
as an 8mm implant.
VOLUME OF PRODUCT IN COMMERCE 197
units
DISTRIBUTION Nationwide
PRODUCT Ocular Conformer, Sterile. The device is intended to be used as a
post eye surgery device to prevent closure or adhesion during the healing
process. Catalog number: 9574, Catalog number 9548, Catalog number 9549, Catalog
number 9779, and Catalog number 9780, CODE Lot number 001061103C, Lot number
002010204-C, Lot number 003061103C, Lot number 002050804C, Lot number
006101204-C
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Porex Surgical, Inc., Newnan, GA,
Manufacturer: R.O. Gulden &
Co., Inc., Elkins Park, PA.
REASON The Ocular Conformers were distributed
with an expired expiration date.
VOLUME OF PRODUCT IN
COMMERCE 9 units
DISTRIBUTION PA, Canada and
Germany
PRODUCT Histochemical
PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225
mL, Light Green SF Yellowish
Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL'; Each kit provides reagents sufficient for a maximum of 100 tests. Item
number 64945/93,
CODE Lot # 8055,
Exp. August 31, 2009
RECALLING FIRM/MANUFACTURER EMD
Chemicals, Inc., Gibbstown, NJ,
REASON Two complaints that
kit was not performing properly with positive controls.
VOLUME OF
PRODUCT IN COMMERCE 29 kits (a kit of 4
bottles)
DISTRIBUTION Nationwide
PRODUCT Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile
clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without
Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually
packaged, 10 tubes per carton; Product is intended for use in those patients who
require intermittent or continuous tube feedings via the nasogastric or
nasoenteric route. Catalog/reorder number 20-1225AIV,
CODE Lot number: 32601
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw
Park, IL,
Manufacturer: VIASYS Medsystems, Wheeling, IL.
REASON The male Luer adapter may be the wrong
component therefore the feeding set would not be able to be connected to the
tube nor would the cap fit securely.
VOLUME OF PRODUCT IN
COMMERCE 807 tubes
DISTRIBUTION CA, IL, KY
and MO
PRODUCT Stryker Biotech OP- 1 Implant is indicated for use as an
alternative to autograft in recalcitrant long bone nonunions where use of
autograft is unfeasible and alternative treatments have failed. Catalog Number:
100-25,
CODE Lots Numbers:
FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003,
FC0805004
RECALLING FIRM/MANUFACTURER Stryker Biotech,
Hopkinton, MA
REASON Product package
insert misprint-text offset.
VOLUME OF PRODUCT IN
COMMERCE 803
units
DISTRIBUTION Nationwide
PRODUCT
a) Medtronic iCon Patient Programmer, model 3037. The Patient
programmer is a hand held, battery operated, microcontroller based device for
use by patients to control and monitor external and implantable devices. The
minimum amount of control involves the ability to turn therapy ON or OFF;
maximal control allows the patient to select from different therapies and adjust
the parameters with in the set therapy limits,
b)
Medtronic Patient programmer, model 37742. The Patient programmer is a hand
held, battery operated, microcontroller based device for use by patients to
control and monitor external and implantable devices. The minimum amount of
control involves the ability to tun therapy ON or OFF; maximal control allows
the patient to select from different therapies and adjust the parameters with in
the set therapy limits,
CODE
a) and
b) Serial numbers: NJD058707N, NJD062024N, NJD063259N, and
NJD063324N
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtronic Neuromodulation, Minneapolis, MN,
Manufacturer: Benchmark Electronics Inc., Winona, MN.
REASON
Medtronic is
retrieving four (4) patient programmers that were not properly loaded with
application software. The application software is needed for a patient
programmer to synchronize and bond with a neurostimulation device. Without this
functionality a patient programmer is not useable and can not communicate with a
neurostimulation device.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION GA, MO, NC,
TX
PRODUCT
Integra Dermal Regeneration Template; 8 x 10 in. (20 cm x 25 cm),
Sterile; Catalog number 38101,
CODE Lot Number:
105BA0121823
RECALLING FIRM/MANUFACTURER Integra
LifeSciences Corp., Plainsboro, NJ
REASON Product labeled with an
expiration date on May 2010, while the actual expiration date should be April
2010.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION TN, CA, NY, IN and AL
WEEK ENDING OCTOBER 25
PRODUCT Ultraview
Digital Telemetry Transmitter, Model 91341-09 The Spacelabs Medical Digital
Telemetry system provides continuous electrocardiographic (ECG) monitoring to
detect ST segment changes, abnormal cardiac rhythms, including a systole,
ventricular fibrillation and ventricular tachycardia,
CODE
Serial numbers: 1341-000517,
1341-000518, 1341-000519, 1341-000521, 1341-000524, 1341-000525, 1341-000526,
1341-000527, 1341-000528, 1341-000529, 1341-000530, 1341-000531, 1341-000532,
1341-000533, 1341-000534, 1341-000535, 1341-000536, 1341-000537, 1341-000538,
1341-000539, 1341-000540, 1341-000541, 1341-000543, 1341-000544, 1341-000545,
1341-000546, 1341-000547, 1341-000548, 1341-000549, 1341-000550, 1341-000551,
1341-000552, 1341-000553, 1341-000556, 1341-000557, 1341-000558, 1341-000559,
1341-000560, 1341-000561, 1341-000562, 1341-000563, 1341-000564, 1341-000565,
1341-000566, 1341-000570, 1341-000571, 1341-000572, 1341-000573, 1341-000574,
1341-000575, 1341-000576, 1341-000577, 1341-000578, 1341-000579, 1341-000580,
1341-000582, 1341-000583, 1341-000584, 1341-000585, 1341-000586, 1341-000587,
1341-000589, 1341-000590, 1341-000591, 1341-000592, 1341-000593, 1341-000594,
1341-000595, 1341-000596, 1341-000597, 1341-000598, 1341-000599, 1341-000600,
1341-000601, 1341-000602, 1341-000603, 1341-000604, 1341-000605, 1341-000606,
1341-000607, 1341-000611, 1341-000612, 1341-000613, 1341-000614, 1341-000615,
1341-000616, 1341-000617, 1341-000618, 1341-000619, 1341-000620, 1341-000621,
1341-000622, 1341-000623, 1341-000624, 1341-000625, 1341-000626, 1341-000627,
1341-000628, 1341-000630, 1341-000631, 1341-000632, 1341-000633, 1341-000634,
1341-000635, 1341-000636, 1341-000637, 1341-000638, 1341-000639, 1341-000640,
1341-000641, 1341-000642, 1341-000643, 1341-001239, 1341-001240, 1341-000245,
1341-000246, 1341-000247, 1341-000248, 1341-000250, 1341-000251, 1341-000252,
1341-000253, 1341-000254, 1341-000255, 1341-000256, 1341-000257, 1341-000508,
1341-000509, 1341-000510, 1341-000511, 1341-000512, 1341-000513, 1341-000514,
1341-000699, 1341-000700, 1341-001029, 1341-001033, 1341-001034, 1341-001035,
1341-001037, 1341-001038, 1341-001039, 1341-001040, 1341-001041, 1341-001042,
1341-001043, 1341-001045, 1341-001046, 1341-001047, 1341-001048, 1341-001049,
1341-001050, 1341-001051, 1341-001053, 1341-001055, 1341-001056, 1341-001057,
1341-001058, 1341-001059, 1341-001095, 1341-001242, 1341-001244, 1341-001390,
1341-001391, 1341-001393, 1341-001394, 1341-001395, 1341-001396, 1341-001397,
1341-001398, 1341-001399, 1341-001400, 1341-001401, 1341-001428, 1341-001429,
1341-001446, 1341-001448, 1341-001450, 1341-001452, 1341-001454, 1341-001455,
1341-001456, 1341-001457, 1341-001636, 1341-001637, 1341-001638, 1341-001639,
1341-001640, 1341-001749, 1341-001750, 1341-001933, 1341-001934, 1341-001935,
1341-001936, 1341-001937, 1341-001938, 1341-001952, 1341-001953, 1341-001954,
1341-001955, 1341-001956, 1341-001957, 1341-001958, 1341-001959, 1341-001960,
1341-001940, 1341-001941, 1341-001942, 1341-001943, 1341-001944, 1341-001945,
1341-001946, 1341-001947, 1341-001948, 1341-001949, 1341-001950, 1341-001951,
1341-001234, 1341-001235, 1341-001236, 1341-001237, 1341-001372, 1341-001373,
1341-001374, 1341-001375, 1341-001376, 1341-001377, 1341-000098, 1341-000099,
1341-000100, 1341-000101, 1341-000102, 1341-000103, 1341-000104, 1341-000105,
1341-000106, 1341-000107, 1341-000108, 1341-000109, 1341-000110, 1341-000111,
1341-000112, 1341-000113, 1341-000114, 1341-000115, 1341-000234, 1341-000235,
1341-000236, 1341-000237, 1341-000238, 1341-000239, 1341-000240, 1341-000241,
1341-000242, 1341-000243, 1341-000244, 1341-000260, 1341-000261, 1341-000262,
1341-000263, 1341-000264, 1341-000265, 1341-000266, 1341-000427, 1341-000428,
1341-000429, 1341-000430, 1341-000431, 1341-000432, 1341-000433, 1341-000434,
1341-000435, 1341-000436, 1341-000437, 1341-000438, 1341-000439, 1341-000440,
1341-000441, 1341-000442, 1341-000443, 1341-000444, 1341-000445, 1341-000446,
1341-000830, 1341-000831, 1341-000832, 1341-000833, 1341-000834, 1341-000835,
1341-000836, 1341-000837, 1341-000838, 1341-000839, 1341-000840, 1341-000841,
1341-000842, 1341-000843, 1341-000844, 1341-000845, 1341-000846, 1341-000847,
1341-000848, 1341-000849, 1341-000850, 1341-000851, 1341-000852, 1341-000853,
1341-000854, 1341-000855, 1341-000856, 1341-000857, 1341-000858, 1341-000859,
1341-000860, 1341-000861, 1341-000862, 1341-000863, 1341-000864, 1341-000865,
1341-000866, 1341-000867, 1341-000868, 1341-000869, 1341-000870, 1341-000871,
1341-000872, 1341-000873, 1341-000874, 1341-000875, 1341-000876, 1341-000877,
1341-000878, 1341-000879, 1341-000880, 1341-000881, 1341-000882, 1341-000883,
1341-000884, 1341-000885, 1341-000886, 1341-000887, 1341-000888, 1341-000889,
1341-000890, 1341-000891, 1341-000892, 1341-000893, 1341-000894, 1341-000895,
1341-000896, 1341-000897, 1341-000898, 1341-000899, 1341-000900, 1341-000901,
1341-000902, 1341-000903, 1341-000904, 1341-000905, 1341-000906, 1341-000907,
1341-000908, 1341-000909, 1341-000910, 1341-000911, 1341-000912, 1341-000913,
1341-000914, 1341-000915, 1341-000916, 1341-000917, 1341-000918, 1341-000919,
1341-000920, 1341-000921, 1341-000922, 1341-000923, 1341-000924, 1341-001145,
1341-001146, 1341-001147, 1341-001148, 1341-001149, 1341-001150, 1341-001151,
1341-001649, 1341-001096, 1341-001097, 1341-001098, 1341-001099, 1341-001100,
1341-001101, 1341-001102, 1341-001103, 1341-001104, 1341-001105, 1341-001106,
1341-001107, 1341-001108, 1341-001109, 1341-001110, 1341-001111, 1341-001112,
1341-001113, 1341-001114, 1341-001115, 1341-001116, 1341-001117, 1341-001118,
1341-001119, 1341-001120, 1341-001121, 1341-001122, 1341-001123, 1341-001124,
1341-001125, 1341-001126, 1341-001127, 1341-001128, 1341-001129, 1341-001130,
1341-001131, 1341-001132, 1341-001133, 1341-001134, 1341-001135, 1341-001136,
1341-001137, 1341-001138, 1341-001139, 1341-001202, 1341-001203, 1341-001204,
1341-001205, 1341-001206, 1341-001207, 1341-001208, 1341-001209, 1341-001210,
1341-001211, 1341-001212, 1341-001213, 1341-001214, 1341-001215, 1341-001216,
1341-001249, 1341-001250, 1341-001251, 1341-001252, 1341-001253, 1341-001254,
1341-001255, 1341-001256, 1341-001257, 1341-001258, 1341-001259, 1341-001260,
1341-001261, 1341-001262, 1341-001263, 1341-001264, 1341-001265, 1341-001266,
1341-001267, 1341-001268, 1341-001269, 1341-001270, 1341-001271, 1341-001272,
1341-001273, 1341-001274, 1341-001276, 1341-001277, 1341-001278, 1341-001656,
1341-001657, 1341-001658, 1341-001659, 1341-001660, 1341-001661, 1341-001662,
1341-001663, 1341-001692, 1341-002117, 1341-002162, 1341-000320, 1341-000321,
1341-000322, 1341-000323, 1341-000324, 1341-000325, 1341-000326, 1341-000327,
1341-000328, 1341-000329, 1341-000330, 1341-000331, 1341-000332, 1341-000333,
1341-000334, 1341-000335, 1341-000336, 1341-000337, 1341-000338, 1341-000339,
1341-000340, 1341-000341, 1341-000342, 1341-000343, 1341-000344, 1341-000345,
1341-000346, 1341-000347, 1341-000348, 1341-000349, 1341-000350, 1341-000351,
1341-000352, 1341-000353, 1341-000354, 1341-000355, 1341-000356, 1341-000357,
1341-000358, 1341-000359, 1341-000360, 1341-000361, 1341-000362, 1341-000363,
1341-000364, 1341-000365, 1341-000366, 1341-000367, 1341-000368, 1341-000369,
1341-000370, 1341-000371, 1341-000372, 1341-000373, 1341-000374, 1341-000375,
1341-000376, 1341-000377, 1341-001699, 1341-001700, 1341-001701, 1341-001702,
1341-001703, 1341-001704, 1341-001705, 1341-001706, 1341-001707, 1341-001708,
1341-001709, 1341-001710, 1341-001711, 1341-001712, 1341-001713, 1341-001714,
1341-001715, 1341-001716, 1341-001717, 1341-001718, 1341-001719, 1341-001720,
1341-001721, 1341-001722, 1341-001723, 1341-001724, 1341-001725, 1341-001726,
1341-001727, 1341-001728, 1341-001729, 1341-001730, 1341-001731, 1341-001732,
1341-001733, 1341-001734, 1341-001735, 1341-001736, 1341-001737, 1341-001738,
1341-001739, 1341-001740, 1341-001741, 1341-001742, 1341-001743, 1341-001744,
1341-001745, 1341-001746, 1341-001886, 1341-001887, 1341-001939, 1341-002143,
1341-002144, 1341-002145, 1341-002146, 1341-002147, 1341-002148, 1341-002149,
1341-002150, 1341-002151, 1341-002152, 1341-002153, 1341-002154, 1341-002155,
1341-002156, 1341-002157, 1341-002158, 1341-001758, 1341-001759, 1341-001760,
1341-001761, 1341-001641, 1341-001642, 1341-001643, 1341-001644, 1341-001645,
1341-001646, 1341-001647, 1341-001648, 1341-001083, 1341-001084, 1341-001085,
1341-001086, 1341-001087, 1341-001088, 1341-000569, 1341-000567, 1341-001217,
1341-000379, 1341-000380, 1341-000382, 1341-000383, 1341-000384, 1341-000385,
1341-000388, 1341-000389, 1341-000390, 1341-000393, 1341-000396, 1341-000398,
1341-000399, 1341-000403, 1341-000404, 1341-000405, 1341-000406, 1341-000407,
1341-000408, 1341-000929, 1341-000930, 1341-000931, 1341-000932, 1341-000933,
1341-000934, 1341-000935, 1341-000936, 1341-000937, 1341-000938, 1341-000939,
1341-000940, 1341-000941, 1341-000943, 1341-000944, 1341-000945, 1341-000946,
1341-000947, 1341-000948, 1341-000949, 1341-000950, 1341-000951, 1341-000952,
1341-000953, 1341-000954, 1341-000955, 1341-000956, 1341-000957, 1341-000959,
1341-000960, 1341-000961, 1341-000963, 1341-000964, 1341-000965, 1341-000967,
1341-000968, 1341-000970, 1341-000971, 1341-000972, 1341-000973, 1341-000974,
1341-000975, 1341-000976, 1341-000977, 1341-000979, 1341-000981, 1341-000982,
1341-000983, 1341-000985, 1341-000986, 1341-000987, 1341-000988, 1341-001600,
1341-001601, 1341-001602, 1341-001603, 1341-001604, 1341-001605, 1341-001606,
1341-001607, 1341-001608, 1341-001609, 1341-001610, 1341-001611, 1341-001612,
1341-001613, 1341-001614, 1341-001615, 1341-001616, 1341-001617, 1341-001618,
1341-001619, 1341-001620, 1341-001621, 1341-001622, 1341-001623, 1341-001624,
1341-001625, 1341-001626, 1341-001627, 1341-001628, 1341-001629, 1341-001630,
1341-001631, 1341-001632, 1341-001633, 1341-001634, 1341-001635, 1341-001747,
1341-001748, 1341-001888, 1341-001889, 1341-001890, 1341-001891, 1341-001892,
1341-001893, 1341-001894, 1341-001895, 1341-001896, 1341-001897, 1341-001898,
1341-001899, 1341-001900, 1341-001901, 1341-001902, 1341-001903, 1341-001904,
1341-001905, 1341-001906, 1341-001907, 1341-001908, 1341-001909, 1341-001910,
1341-001911, 1341-001912, 1341-001913, 1341-001914, 1341-001915, 1341-001916,
1341-001917, 1341-001918, 1341-001919, 1341-001920, 1341-001921, 1341-001922,
1341-001923, 1341-001924, 1341-001925, 1341-001926, 1341-001927, 1341-001928,
1341-001929, 1341-000381, 1341-000386, 1341-000387, 1341-000391, 1341-000392,
1341-000394, 1341-000397, 1341-000400, 1341-000401, 1341-000402, 1341-000969,
1341-000644, 1341-000645, 1341-000646, 1341-000647, 1341-000648, 1341-001978,
1341-001979, 1341-001980, 1341-001981, 1341-001982, 1341-001983, 1341-001984,
1341-001985, 1341-001986, 1341-001987, 1341-001988, 1341-001989, 1341-001990,
1341-001991, 1341-002078, 1341-002079, 1341-002080, 1341-002081, 1341-001968,
1341-001969, 1341-001970, 1341-001971, 1341-001972, 1341-001973, 1341-001974,
1341-001975, 1341-001488, 1341-001489, 1341-001490, 1341-001491, 1341-001492,
1341-001493, 1341-001494, 1341-001495, 1341-001496, 1341-001497, 1341-001498,
1341-001499, 1341-001500, 1341-001501, 1341-001502, 1341-001503, 1341-001504,
1341-001505, 1341-001506, 1341-001507, 1341-001508, 1341-001509, 1341-001510,
1341-001511, 1341-001512, 1341-001513, 1341-001514, 1341-001515, 1341-001516,
1341-001517, 1341-001518, 1341-001519, 1341-001520, 1341-001521, 1341-001522,
1341-001523, 1341-001524, 1341-001525, 1341-001526, 1341-001527, 1341-001528,
1341-001529, 1341-001530, 1341-001531, 1341-001532, 1341-001533, 1341-001534,
1341-001535, 1341-001536, 1341-001537, 1341-001538, 1341-001539, 1341-001540,
1341-001541, 1341-001542, 1341-001543, 1341-001544, 1341-001545, 1341-001546,
1341-001547, 1341-001548, 1341-001549, 1341-001550, 1341-001551, 1341-001552,
1341-001553, 1341-001554, 1341-001555, 1341-001556, 1341-001557, 1341-001558,
1341-001559, 1341-002024, 1341-002025, 1341-002026, 1341-002163, 1341-001030,
1341-001031, 1341-001032, 1341-001806, 1341-001931, 1341-001932, 1341-000608,
1341-000609, 1341-000687, 1341-000688, 1341-000690, 1341-000691, 1341-000692,
1341-000693, 1341-000694, 1341-000695, 1341-000696, 1341-000697, 1341-000698,
1341-001015, 1341-001016, 1341-001017, 1341-001018, 1341-001019, 1341-001020,
1341-001021, 1341-001022, 1341-001023, 1341-001024, 1341-001025, 1341-001026,
1341-001027, 1341-001392, 1341-001445, 1341-001447, 1341-001449, 1341-001451,
1341-001453, 1341-001458, 1341-001459, 1341-001460, 1341-001461, 1341-001462,
1341-001463, 1341-001464, 1341-001465, 1341-001466, 1341-001467, 1341-001468,
1341-001469, 1341-001470, 1341-001471, 1341-001472, 1341-001473, 1341-001474,
1341-001475, 1341-001476, 1341-001477, 1341-001478, 1341-001479, 1341-001480,
1341-001481, 1341-001482, 1341-001483, 1341-001484, 1341-001485, 1341-001486,
1341-001487, 1341-002027, 1341-002028, 1341-002029, 1341-002030, 1341-002031,
1341-002032, 1341-002033, 1341-002034, 1341-002035, 1341-002038, 1341-002039,
1341-002040, 1341-002041, 1341-002042, 1341-002043, 1341-002044, 1341-002045,
1341-002046, 1341-002047, 1341-002048, 1341-002049, 1341-002050, 1341-002051,
1341-002052, 1341-002082, 1341-002083, 1341-001402, 1341-001403, 1341-001404,
1341-001409, 1341-001410, 1341-001411, 1341-001412, 1341-001413, 1341-001414,
1341-001415, 1341-001416, 1341-001417, 1341-001418, , 1341-000736, 1341-000737,
1341-000738, 1341-000739, 1341-000740, 1341-000741, 1341-000742, 1341-000743,
1341-000744, 1341-000745, 1341-000746, 1341-000747, 1341-000748, 1341-000749,
1341-000750, 1341-000751, 1341-000752, 1341-000753, 1341-000754, 1341-000755,
1341-000756, 1341-000757, 1341-000758, 1341-000759, 1341-000760, 1341-000761,
1341-000762, 1341-000763, 1341-000764, 1341-000765, 1341-000766, 1341-000767,
1341-000768, 1341-000769, 1341-000770, 1341-000771, 1341-000772, 1341-000773,
1341-000774, 1341-000775, 1341-000776, 1341-000777, 1341-000778, 1341-000779,
1341-000780, 1341-000781, 1341-000782, 1341-000783, 1341-000784, 1341-000785,
1341-000786, 1341-000787, 1341-000788, 1341-000789, 1341-000790, 1341-000791,
1341-000792, 1341-000793, 1341-000794, 1341-000795, 1341-000796, 1341-000797,
1341-000798, 1341-000799, 1341-000800, 1341-000801, 1341-000802, 1341-000803,
1341-000804, 1341-000805, 1341-000806, 1341-000807, 1341-000808, 1341-000809,
1341-000810, 1341-000811, 1341-000812, 1341-000813, 1341-000814, 1341-000815,
1341-000816, 1341-000817, 1341-000818, 1341-000819, 1341-000820, 1341-000821,
1341-000822, 1341-000823, 1341-000824, 1341-000825, 1341-000826, 1341-000827,
1341-000828, 1341-000829, 1341-001003, 1341-001004, 1341-001005, 1341-001006,
1341-001007, 1341-001008, 1341-001009, 1341-001010, 1341-001011, 1341-001012,
1341-001013, 1341-001014, 1341-001650, 1341-001651, 1341-001652, 1341-001653,
1341-001654, 1341-001655, 1341-001762, 1341-001763, 1341-001764, 1341-001765,
1341-001766, 1341-001767, 1341-001768, 1341-001769, 1341-001770, 1341-001771,
1341-001772, 1341-001773, 1341-001774, 1341-001775, 1341-001776, 1341-001777,
1341-001778, 1341-001779, 1341-001780, 1341-001781, 1341-001782, 1341-001783,
1341-001784, 1341-001785, 1341-001786, 1341-001787, 1341-001788, 1341-001789,
1341-001790, 1341-002164, 1341-001791, 1341-001792, 1341-001793, 1341-001794,
1341-001795, 1341-001796, 1341-001797, 1341-001798, 1341-001799, 1341-001800,
1341-001801, 1341-001802, 1341-001803, 1341-001804, 1341-001805, 1341-000515,
1341-000249, 1341-000258, 1341-000259, 1341-001241, 1341-001378, 1341-001379,
1341-001380, 1341-001381, 1341-001382, 1341-001383, 1341-001384, 1341-001385,
1341-001386, 1341-001387, 1341-001388, 1341-001389, 1341-001419, 1341-001420,
1341-001421, 1341-001422, 1341-001423, 1341-001424, 1341-001425, 1341-001426,
1341-001427, 1341-001430, 1341-001431, 1341-001432, 1341-001433, 1341-001996,
1341-000689, 1341-001664, 1341-001665, 1341-001666, 1341-001667, 1341-001668,
1341-001669, 1341-001670, 1341-001671, 1341-001672, 1341-001673, 1341-001674,
1341-001675, 1341-001676, 1341-001677, 1341-001678, 1341-001679, 1341-001680,
1341-001681, 1341-001682, 1341-001683, 1341-001684, 1341-001685, 1341-001686,
1341-001687, 1341-001688, 1341-001689, 1341-001690, 1341-001691, 1341-001434,
1341-001435, 1341-001436, 1341-001437, 1341-001438, 1341-001439, 1341-001440,
1341-001441, 1341-001442, 1341-001443, 1341-001444, 1341-000004, 1341-000009,
1341-000025, 1341-000026, 1341-000027, 1341-000028, 1341-000029, 1341-000072,
1341-000073, 1341-000074, 1341-000080, 1341-000081, 1341-000082, 1341-000083,
1341-000084, 1341-000085, 1341-000086, 1341-000087, 1341-000088, 1341-000089,
1341-000090, 1341-000091, 1341-000092, 1341-000093, 1341-000094, 1341-000095,
1341-000096, 1341-000097, 1341-000304, 1341-000305, 1341-000306, 1341-000307,
1341-000308, 1341-000309, 1341-000310, 1341-000311, 1341-000312, 1341-000313,
1341-000314, 1341-000315, 1341-000316, 1341-000317, 1341-000318, 1341-000319,
1341-000409, 1341-000410, 1341-000411, 1341-000412, 1341-000413, 1341-000414,
1341-000415, 1341-000416, 1341-000417, 1341-000418, 1341-000419, 1341-000420,
1341-000421, 1341-000422, 1341-000423, 1341-000424, 1341-000425, 1341-000426,
1341-001757, 1341-001930, 1341-002122, 1341-002123, 1341-002124, 1341-002125,
1341-002126, 1341-000452, 1341-000453, 1341-000454, 1341-000455, 1341-000456,
1341-000457, 1341-000458, 1341-000459, 1341-000460, 1341-000461, 1341-000462,
1341-000463, 1341-000464, 1341-000465, 1341-000466, 1341-000467, 1341-000468,
1341-000469, 1341-000470, 1341-000471, 1341-000472, 1341-000473, 1341-000474,
1341-000475, 1341-000476, 1341-000477, 1341-000478, 1341-000479, 1341-000480,
1341-000481, 1341-000482, 1341-000483, 1341-000484, 1341-000485, 1341-000486,
1341-000487, 1341-000488, 1341-000489, 1341-000490, 1341-000491, 1341-000492,
1341-000493, 1341-000494, 1341-000495, 1341-000496, 1341-000497, 1341-000498,
1341-001756, 1341-002014, 1341-002015, 1341-001560, 1341-001561, 1341-001562,
1341-001563, 1341-001564, 1341-001565, 1341-001566, 1341-001567, 1341-001568,
1341-001569, 1341-001570, 1341-001571, 1341-001572, 1341-001573, 1341-001574,
1341-001575, 1341-001576, 1341-001577, 1341-001578, 1341-001579, 1341-001580,
1341-001581, 1341-001582, 1341-001583, 1341-001584, 1341-001585, 1341-001586,
1341-001587, 1341-001588, 1341-001589, 1341-001590, 1341-001591, 1341-001592,
1341-001593, 1341-001594, 1341-001595, 1341-001596, 1341-001597, 1341-001598,
1341-001599, 1341-000989, 1341-000990, 1341-000991, 1341-000992, 1341-000993,
1341-000994, 1341-000995, 1341-000996, 1341-000997, 1341-000998, 1341-000999,
1341-001000, 1341-001001, 1341-001002, 1341-001089, 1341-001090, 1341-001091,
1341-001092, 1341-001093, 1341-001094, 1341-000116, 1341-000117, 1341-000118,
1341-000119, 1341-000120, 1341-000121, 1341-000122, 1341-000123, 1341-000124,
1341-000125, 1341-000126, 1341-000127, 1341-000128, 1341-000129, 1341-000130,
1341-000131, 1341-000132, 1341-000133, 1341-000134, 1341-000135, 1341-000136,
1341-000137, 1341-000138, 1341-000139, 1341-000140, 1341-000141, 1341-000142,
1341-000143, 1341-000144, 1341-000145, 1341-000146, 1341-000147, 1341-000148,
1341-000149, 1341-000150, 1341-000151, 1341-000267, 1341-000268, 1341-000269,
1341-000270, 1341-000271, 1341-000272, 1341-000273, 1341-000274, 1341-000275,
1341-000276, 1341-000277, 1341-000278, 1341-000279, 1341-000280, 1341-000281,
1341-000282, 1341-000283, 1341-000284, 1341-000285, 1341-000286, 1341-000287,
1341-000288, 1341-000289, 1341-000290, 1341-000291, 1341-000292, 1341-000293,
1341-000294, 1341-000295, 1341-000296, 1341-000297, 1341-000298, 1341-000299,
1341-000300, 1341-000301, 1341-000302, 1341-000303, 1341-001285, 1341-001299,
1341-001300, 1341-001301, 1341-001302, 1341-001303, 1341-001304, 1341-001305,
1341-001306, 1341-001307, 1341-001308, 1341-001309, 1341-001310, 1341-001311,
1341-001312, 1341-001313, 1341-001314, 1341-001315, 1341-001316, 1341-001317,
1341-001318, 1341-001319, 1341-001320, 1341-001321, 1341-001322, 1341-001323,
1341-001324, 1341-001325, 1341-001326, 1341-001327, 1341-001328, 1341-001329,
1341-001330, 1341-001331, 1341-001332, 1341-001333, 1341-001334, 1341-001335,
1341-001336, 1341-001337, 1341-001338, 1341-001339, 1341-001340, 1341-001341,
1341-001342, 1341-001343, 1341-001344, 1341-001345, 1341-001346, 1341-001347,
1341-001348, 1341-001349, 1341-001350, 1341-001351, 1341-001352, 1341-001353,
1341-001354, 1341-001355, 1341-001356, 1341-001357, 1341-001358, 1341-001359,
1341-001360, 1341-001361, 1341-001362, 1341-001363, 1341-001364, 1341-001365,
1341-001366, 1341-001367, 1341-001368, 1341-001369, 1341-001370, 1341-001371, ,
1341-001693, 1341-001694, 1341-001695, 1341-001696, 1341-001697, 1341-001698, ,
1341-000011, 1341-000012, 1341-000013, 1341-000014, 1341-000015, 1341-000016,
1341-000017, 1341-000018, 1341-000019, 1341-000020, 1341-000021, 1341-000022,
1341-000023, 1341-000024, 1341-000030, 1341-000031, 1341-000032, 1341-000033,
1341-000034, 1341-000035, 1341-000036, 1341-000037, 1341-000038, 1341-000039,
1341-000040, 1341-000041, 1341-000042, 1341-000043, 1341-000044, 1341-000045,
1341-000046, 1341-000047, 1341-000048, 1341-000049, 1341-000050, 1341-000051,
1341-000052, 1341-000053, 1341-000054, 1341-000055, 1341-000056, 1341-000057,
1341-000058, 1341-000059, 1341-000060, 1341-000061, 1341-000062, 1341-000063,
1341-000064, 1341-000065, 1341-000066, 1341-000067, 1341-000068, 1341-000069,
1341-000070, 1341-000071, 1341-000075, 1341-000076, 1341-000077, 1341-000078,
1341-000079, 1341-000448, 1341-000449, , 1341-000682, 1341-000683, 1341-000684,
1341-000685, 1341-000686, 1341-001751, 1341-001752, 1341-001753, 1341-001754,
1341-001755, , 1341-000703, 1341-000704, 1341-000705, 1341-000706, 1341-000707,
1341-000708, 1341-000709, 1341-000710, 1341-000711, 1341-000712, 1341-000713,
1341-000714, 1341-000715, 1341-000716, 1341-000717, 1341-000718, 1341-000719,
1341-000720, 1341-000721, 1341-000722, 1341-000723, 1341-000724, 1341-000725,
1341-000726, 1341-000727, 1341-000728, 1341-000729, 1341-000730, 1341-000731,
1341-000732, 1341-000733, 1341-000734, 1341-000735, 1341-001807, 1341-001808,
1341-001809, 1341-001810, 1341-001811, 1341-001812, 1341-001813, 1341-001814,
1341-001815, 1341-001816, 1341-001817, 1341-001818, 1341-001819, 1341-001820,
1341-001821, 1341-001822, 1341-001823, 1341-001824, 1341-001825, 1341-001829,
1341-001830, 1341-001831, 1341-001832, 1341-001833, 1341-001834, 1341-001835,
1341-001836, 1341-001837, 1341-001838, 1341-001839, 1341-001840, 1341-001841,
1341-001842, 1341-001843, 1341-001844, 1341-001845, 1341-001846, 1341-001847,
1341-001848, 1341-001849, 1341-001850, 1341-001851, 1341-001852, 1341-001853,
1341-001854, 1341-001855, 1341-001856, 1341-001857, 1341-001858, 1341-001859,
1341-001860, 1341-001861, 1341-001862, 1341-001863, 1341-001864, 1341-001865,
1341-001866, 1341-001867, 1341-001868, 1341-001869, 1341-001870, 1341-001871,
1341-001872, 1341-001873, 1341-001874, 1341-001875, 1341-001876, 1341-001877,
1341-001878, 1341-001879, 1341-001880, 1341-001881, 1341-001882, 1341-001883,
1341-001884, 1341-001885, 1341-011826, 1341-011827, 1341-011828, 1341-000192,
1341-000193, 1341-000194, 1341-000195, 1341-000196, 1341-000197, 1341-000198,
1341-000199, 1341-000200, 1341-000201, 1341-000202, 1341-000203, 1341-000204,
1341-000205, 1341-000206, 1341-000207, 1341-000208, 1341-000209, 1341-000210,
1341-000211, 1341-000212, 1341-000213, 1341-000214, 1341-000215, 1341-000216,
1341-000217, 1341-000218, 1341-000219, 1341-000220, 1341-000221, 1341-000222,
1341-000223, 1341-000224, 1341-000225, 1341-000226, 1341-000227, 1341-000228,
1341-000229, 1341-000230, 1341-000231, 1341-000232, 1341-000233, 1341-000925,
1341-000926, 1341-000927, 1341-000928, 1341-001992, 1341-001993, 1341-001994,
1341-001995, 1341-001997, 1341-001998, 1341-001999, 1341-002000, 1341-002001,
1341-002002, 1341-002003, 1341-002004, 1341-002005, 1341-002006, 1341-002007,
1341-002008, 1341-002009, 1341-002010, 1341-002011, 1341-002012, 1341-002013,
1341-002016, 1341-002017, 1341-002018, 1341-002019, 1341-002020, 1341-002021,
1341-002022, 1341-002023, 1341-002053, 1341-002054, 1341-002055, 1341-002056,
1341-002057, 1341-002058, 1341-002059, 1341-002060, 1341-002061, 1341-002062,
1341-002063, 1341-002064, 1341-002065, 1341-002066, 1341-002067, 1341-002068,
1341-002069, 1341-002070, 1341-002071, 1341-002072, 1341-002073, 1341-002074,
1341-002075, 1341-002076, 1341-002077, 1341-002084, 1341-002085, 1341-002086,
1341-002087, 1341-002088, 1341-002089, 1341-002090, 1341-002091, 1341-002092,
1341-002093, 1341-002094, 1341-002095, 1341-002096, 1341-002097, 1341-002098,
1341-002099, 1341-002100, 1341-002101, 1341-002102, 1341-002103, 1341-002104,
1341-002105, 1341-002106, 1341-002107, 1341-002108, 1341-002109, 1341-002110,
1341-002111, 1341-002112, 1341-002113, 1341-002114, 1341-002115, 1341-002116,
1341-002118, 1341-002119, 1341-002120, 1341-002121, 1341-002127, 1341-002128,
1341-002129, 1341-002130, 1341-002131, 1341-002132, 1341-002133, 1341-002134,
1341-002135, 1341-002136, 1341-002137, 1341-002138, 1341-002139, 1341-002140,
1341-002141, 1341-002142, 1341-002159, 1341-002160, 1341-002161, 1341-002165,
1341-002166, 1341-002167, 1341-002168, 1341-002169, 1341-002170, , 1341-000649,
1341-000650, 1341-000651, 1341-000652, 1341-000653, 1341-000654, 1341-000655,
1341-000656, 1341-000657, 1341-000658, 1341-000659, 1341-000660, 1341-000661,
1341-000662, 1341-000663, 1341-000664, 1341-000665, 1341-000666, 1341-000667,
1341-000668, 1341-000669, 1341-000670, 1341-000671, 1341-000672, 1341-000673,
1341-000674, 1341-000675, 1341-000676, 1341-000677, 1341-000678, 1341-000679,
1341-000680, 1341-000681, 1341-001060, 1341-001061, 1341-001062, 1341-001063,
1341-001064, 1341-001065, 1341-001066, 1341-001067, 1341-001068, 1341-001069,
1341-001070, 1341-001071, 1341-001072, 1341-001073, 1341-001074, 1341-001075,
1341-001076, 1341-001077, 1341-001078, 1341-001079, 1341-001080, 1341-001081,
1341-001082, , 1341-000152, 1341-000153, 1341-000154, 1341-000155, 1341-000156,
1341-000157, 1341-000158, 1341-000159, 1341-000160, 1341-000161, 1341-000162,
1341-000163, 1341-000164, 1341-000165, 1341-000166, 1341-000167, 1341-000168,
1341-000169, 1341-000170, 1341-000171, 1341-000172, 1341-000173, 1341-000174,
1341-000175, 1341-000176, 1341-000177, 1341-000178, 1341-000179, 1341-000180,
1341-000181, 1341-000182, 1341-000183, 1341-000184, 1341-000185, 1341-000186,
1341-000187, 1341-000188, 1341-000189, 1341-000190, 1341-000191, 1341-001158,
1341-001163, 1341-001164, 1341-001165, 1341-001166, 1341-001167, 1341-001168,
1341-001169, 1341-001170, 1341-001171, 1341-001172, 1341-001173, 1341-001174,
1341-001175, 1341-001176, 1341-001177, 1341-001178, 1341-001179, 1341-001180,
1341-001181, 1341-001182, 1341-001183, 1341-001184, 1341-001185, 1341-001186,
1341-001187, 1341-001188, 1341-001189, 1341-001190, 1341-001191, 1341-001192,
1341-001193, 1341-001194, 1341-001195, 1341-001196, 1341-001197, 1341-001198,
1341-001199, 1341-001200, 1341-001201, 1341-001275, 1341-001405, 1341-001406,
1341-001407, and 1341-001408
RECALLING
FIRM/MANUFACTURER Spacelabs Healthcare, Inc., Issaquah, WA,
REASON
During battery insertion there is
potential for patient waveforms to move to an open receiver module or to an
occupied receiver causing the intermittent inappropriate monitoring of both
patients for several minutes.
VOLUME OF PRODUCT IN
COMMERCE 2,055 units
DISTRIBUTION Nationwide
PRODUCT HeartStarMRtX Defibrillator/Monitor Models: M3535A/M3536A
HeartStart MRx with a native 256Mbyte internal memory card with date code "0308.
The product is used for the termination of ventricular tachycardia and
ventricular fibrillation,
CODE
Serial Numbers: US00100694- US00100695
US00101003 US00101148 US00101277 US00101427 US00101443 US00101696 US00101876
US00102033 US00102552 US00102602 US00202756 US00202955 US00203505 US00203923
US00204295 US00204347 US00204361 US00204423 US00204438 US00204490 US00204648
US00205100 US00205625 US00205636 US00205650- US00205651 US00205660 US00205666
US00205688 US00205751 US00205839 US00205994 US00206144 US00206531 US00206641
US00207021 US00207313 US00207485 US00207604 US00207924 US00207930 US00208087
US00208140 US00208752 US00208789- US00208790 US00209355 US00209715 US00210183
US00210304 US00210783 US00210982 US00212242 US00212790 US00315280 US00315447
US00315464 US00316930 US00318057 US00318523 US00318538 US00319936 US00321428
US00324554 US00324581- US00324584 US00324586 US00324614- US00324616 US00324619-
US00324620 US00324622 US00324624- US00324625 US00324627 US00324642 US00324645-
US00324646 US00324659 US00324680 US00324707 US00324712- US00324713 US00324718
US00324720 US00324727- US00324731 US00324734 US00324736 US00324744 US00324748-
US00324749 US00324751 US00324754 US00324756 US00324758- US00324761 US00324763-
US00324765 US00324767- US00324769 US00324771 US00324773 US00324775 US00324777
US00324779- US00324786 US00324788- US00324789 US00324802- US00324838 US00324841-
US00324845 US00324847- US00324856 US00324858- US00324929 US00324932- US00324942
US00324944 US00324947- US00324952 US00324954 US00324956- US00324959 US00324961-
US00324968 US00324970- US00324971 US00324973- US00324975 US00324979- US00324980
US00324982 US00324984 US00324986 US00324997 US00325003 US00325005 US00325007-
US00325008 US00325010 US00325023- US00325024 US00325028 US00325031- US00325032
US00325035 US00325038 US00325040- US00325043 US00325045 US00325048- US00325049
US00325054- US00325057 US00325062- US00325064 US00325066 US00325068- US00325069
US00325081- US00325082 US00325085- US00325087 US00325094- US00325096 US00325166
US00325231 US00325234- US00325235 US00325583- US00325587 US00325612- US00325613
US00325616 US00325621 US00325623- US00325624 US00325628 US00325651 US00325654-
US00325655 US00325661- US00325664 US00325674- US00325690 US00325692 US00325694
US00325696- US00325701 US00325703- US00325726 US00325728- US00325731 US00325734-
US00325742 US00325744- US00325746 US00325748- US00325755 US00325757- US00325759
US00325762- US00325763 US00325766- US00325768 US00325770- US00325771 US00325773-
US00325775 US00325780- US00325781 US00325787- US00325790 US00325795- US00325797
US00325799- US00325800 US00325804 US00325806- US00325808 US00325810 US00325812-
US00325814 US00325816- US00325823 US00325827- US00325828 US00325830- US00325838
US00325847- US00325848 US00325851- US00325853 US00325856 US00325858- US00325859
US00325861 US00325863 US00325867 US00325870- US00325871 US00325873- US00325875
US00325877- US00325878 US00325889 US00325903 US00325908- US00325909 US00325943
US00325957 US00325979 US00325994 US00326002 US00326008 US00326034 US00326043
US00326058 US00326061- US00326065 US00326069 US00326073- US00326075 US00326079
US00326084 US00326225 US00326248 US00326350 and US00326505
RECALLING
FIRM/MANUFACTURER Philips Medical Systems, Andover, MA,
REASON
Defective internal memory cards may
exhibit one or more of the following behaviors: "Device repeatedly restarts
approximately every 20 seconds "Slow device start-up of approximately 15 seconds
or more. During this time, the MRx displays either a blank screen or the Philips
HeartStart MRx Start-up screen prior to displaying the selected mode of
operation (i.e. Monitor, AED, Pacing or Manual Defib mode). " Internal Memory
Failure INOP message when attempting to print an event from the Data Management
screen. "When printing from the Data Management screen, a patients Event Summary
prints with some clinical events missing.
VOLUME OF PRODUCT IN
COMMERCE 523 units
DISTRIBUTION Nationwide,
Canada Australia, Brazil , China, France, Germany, Great Britain, Hong Kong,
Indonesia, Italy, Latvia, New Zealand, Saudi Arabia, and South Africa
PRODUCT Sunrise
Medical Quickie Groove Power Wheelchair with Transit option The product is a
powered wheelchair for human use,
CODE Multiple serial numbers, starting with
GRV-100: 182, 181, 178, 176, 166, 161, 160, 151, 150, 115, 110, 109, 106, 100,
099, 098, 094, 082, 081, 079, 076, 073, 064, 058, 056, 054, 053, 050, 044, 043,
041, 040, 035, 033, 021 and 013
RECALLING
FIRM/MANUFACTURER Sunrise Medical, Inc., Fresno, CA,
REASON Rear bolts holding the frame in place may shear
and the front bolts may potentially come off the posts, resulting in partial or
full seat detachment in a sudden stop or crash.
VOLUME OF PRODUCT IN
COMMERCE 36 units
DISTRIBUTION Nationwide,
Canada, New Zealand and
Australia
PRODUCT
a) Exact Calcar Planer Rasp Style Blade, 38mm, REF 31-473795.
Surgical blades used to remove excess bone proximal to the broach face to all
instrument trial to seat properly,
b) Exact Calcar
Planer Rasp Style Blade, 42mm, Biomet Orthopedics, Inc, Warsaw, IN; REF
31-473796. Surgical blades used to remove excess bone proximal to the broach
face to all instrument trial to seat properly,
c)
Exact Calcar Planer Rasp Style Blade, 46mm; REF 31-473797. Surgical blades used
to remove excess bone proximal to the broach face to all instrument trial to
seat properly,
d) Exact Calcar Planer Rasp Style
Blade, 50mm; REF 31-473798. Surgical blades used to remove excess bone proximal
to the broach face to all instrument trial to seat properly,
CODE
a) Lots 739370, 442250, 848550 and
904090;
b) Lots 010180, 865890, 439380, 850170 and 918020;
c) Lots 850560,
439390, 848560 and 918030;
d) Lot 834190
RECALLING
FIRM/MANUFACTURER Biomet, Inc., Warsaw, IN,
REASON The blades
will oxidize after the first cleaning.
VOLUME OF PRODUCT IN
COMMERCE 141 units
DISTRIBUTION Nationwide
and China
PRODUCT
a) Access and Access 2 Immunoassay System,
b) SYNCHRON LXi 725 System,
c) Unicel
DxC 600i System and Unicel Dxl 600 Access Immunoassay System,
d) UniCel Dxl 800 Access Immunoassay System and UniCel DxC 880i
Synchron Access Clinical System,
CODE
a) and b) Peristaltic
Pumps with Serial Numbers above 22349820;
c) Unicel DxC 600i with Peristaltic
Pumps with Serial Numbers above 22349820; Unicel Dxl 600 Peristaltic Pumps with
Serial Numbers of 22965501 and above;
d) Peristaltic Pumps with Serial
Numbers of 22454201 and above
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: Beckman Coulter Inc.,
Fullerton, CA. REASON The field action was initiated after the
firm confirmed reports of premature failure of the waste pump tubing in the
Access and Access 2 Immunoassay Systems. Premature failure of the waste pump
tubing may negatively affect precision.
VOLUME OF PRODUCT IN
COMMERCE 694 units
DISTRIBUTION Nationwide,
and Canada
PRODUCT
NicoletOne photic adapter cable 085-463700,
CODE 085-463700
RECALLING
FIRM/MANUFACTURER Cardinal Health NeuroCare Division, Madison, WI
REASON
The photic adapter cable has a wiring
error which delivers a reduced voltage and results in a decreased intensity of
the NicLED photic. This reduced intensity may fail to elicit a response from a
photosensitive seizure disorder patient which may result in lack of appropriate
treatment for this disorder.
VOLUME OF PRODUCT IN
COMMERCE 92 units
DISTRIBUTION CA FL GA ID IN
LA MD ME MI MO NC NY PA TN TX WA WI China Denmark Indonesia Japan Korea Mexico
Netherlands Russia Saudi Arabia Slovenia
PRODUCT
a)
Apogee Intermittent Catheter, 6 Fr 15", Catalog/Ref No. 1007, Sterile, Latex
free. The device is intended to be used as a urinary incontinence device
designed to drain urine from the bladder,
b)
Apogee Intermittent Catheter, 8 Fr 16", Catalog/Ref No. 1018, Sterile, Latex
free. The device is intended to be used as a urinary incontinence device
designed to drain urine from the bladder,
c)
Apogee Intermittent Catheter, 10 Fr 15", Catalog/Ref No. 1036, Sterile, Latex
free. The device is intended to be used as a urinary
incontinence device designed to drain urine from the
bladder,
d) Apogee Intermittent Catheter with Coude tip, 12 Fr 16", Catalog/Ref No.
1036, Sterile, Latex free. The device is intended to be
used as a urinary incontinence device designed to drain urine from the bladder,
e) Apogee Intermittent Catheter with Coude tip, 14
Fr 16", Catalog/Ref No.1066, Sterile, Latex free. The
device is intended to be used as a urinary incontinence device designed to drain
urine from the bladder,
CODE
a) Lot
number 7208;
b) and c) Lot number 7206;
d) Lot number 6016;
e) Lot
number 7201
RECALLING FIRM/MANUFACTURER Apogee Medical,
Inc., Youngsville, NC,
REASON Due to a package seal defect the catheter
tip may have been inadvertently cut which could cause trauma to the urethra upon
use. Also the sterility of the product could be compromised.
VOLUME
OF PRODUCT IN COMMERCE 23.400
devices
DISTRIBUTION Nationwide and
Canada
PRODUCT
Power Drive. Battery-driven power tool system intended for use
during surgical procedures to provide power to operate various accessories and
attachments. Catalog number 530.100,
CODE All lot numbers
RECALLING
FIRM/MANUFACTURER Synthes U S A, West Chester, PA,
Manufacturer: Synthes
Gmbh, Oberdorf, Switzerland. REASON The product is mislabeled, as the validation for
the previous sterilization parameters cannot be replicated. The currently
validated sterilization parameter is a minimum of 24 minutes prevacuum.
VOLUME OF PRODUCT IN COMMERCE
584
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Centros(TM) 15F x 24cm Chronic Hemodialysis Curved Catheter Set (With Cuff 19cm
From Tip), Catalog No./REF 10303101. Sterile,
b) Centros(TM) 15F x 28cm Chronic Hemodialysis Curved Catheter Set (With Cuff 23cm
From Tip), Catalog No./REF 10303102. Sterile,
c) Centros(TM) 15F x 32cm Chronic Hemodialysis Curved Catheter Set (With Cuff 27cm
From Tip), Catalog No./REF 10303103. Sterile,
CODE
a) Lot numbers: S08B01, S08B05, S08C02,
and S08C07;
b) Lot numbers: S08B02, S08B06, S08C01, S08D02, and S08D11;
c)
Lot numbers: S08B03, S08C03, S08C04, and S08C08
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Angiodynamics, Inc.,
Queensbury, NY, Manufacturer: Via
Biomedical, Maple Grove, MN.
REASON The cuff may be inadequately attached to
the catheter, resulting in possible catheter movement or leakage at the
insertion site.
VOLUME OF PRODUCT IN COMMERCE 1,490
units
DISTRIBUTION Nationwide
PRODUCT
a) PLAC Test Reagent Kit, Catalog numbers 90107 and 90110,
Turbidimetric Immunoassay for the Quantitative Determination of Lp-PLA2 in human
plasma or serum. Product consists of a liquid, ready to use, two reagent kit
assembled in a kit box,
b) PLAC Test ELISA kit,
catalog number 90106, enzyme immunoassay for the quantitative determination of
Lp-PLA2 in human plasma and serum, kit containing coated microwell stripplate
and reagents (12 strips, 1 set calibrators 1 to 6, 0.25 ml each, 20x wash
buffer, 50 mL, conjugate 23 mL, TMB, 11 mL, Stop solution, 11 mL, CODE
All lots
RECALLING
FIRM/MANUFACTURER DiaDexus, Inc., South San Francisco, CA,
REASON
Product may give Lp-PLA2 values at up to
22% lower than accurate values.
VOLUME OF PRODUCT IN
COMMERCE 65 units
DISTRIBUTION Nationwide, UK
and Germany
PRODUCT
GE Voluson® E8 Ultrasound System with software versions 6.0.0,
6.0.1, 6.1.0, 6.2.0, 6.2.1, 6.2.2, 6.2,3, 7.0.0, and 7.01. Intended for use by a
qualified physician for ultrasound evaluation of Fetal OB; abdominal (including
GYN, pelvic and infertility monitoring/follicle development); Pediatric; Small
Organ (breast, testes, thyroid etc.); Neonatal and Adult Cephalic; Cardiac
(adult and pediatric); Musculo-skeletal Conventional and Superficial; Peripheral
Vascular; Transvaginal (TV); Transrectal (TR); and Intraoperative (abdominal ,
PV neurological),
CODE
Serial
numbers: D00854 D03101 D03423 D00152 D00289 D00323 D00408 D00414 D00477 D00482
D00676 D00679 D00838 D00866 D03109 D03172 D03401 D03422 D03441 D03626 D03849
D03855 D03119 D03683 D03866 D00160 D00212 D00283 D00320 D00377 D00427 D00463
D00678 D01032 D01038 D03206 D03287 D03358 D03391 D03498 D03625 D00811 D00832
D03154 D00578 D03492 D03617 D03644 D03677 D03743 D03295 D00161 D00329 D00370
D00371 D00472 D00588 D00589 D00921 D00229 D00164 D00664 D00979 D00998 D01001
D03216 D03655 D00181 D00191 D00269 D00390 D00709 D00717 D00786 D00805 D00882
D00883 D00885 D00886 D00891 D01021 D00857 D03478 D00123 D00530 D00942 D00947
D00948 D01066 D03400 D03427 D03442 D03704 D03183 D03864 D00361 D00737 D03384
D03712 D00738 D00144 D03440 D03233 D03488 D00620 D00895 D00985 D03643 D00211
D00743 D03196 D03342 D03402 D03654 D03742 D03765 D03776 D03779 D03780 D03845
D00724 D00731 D03507 D03490 D03493 D03494 D03495 D00363 D00368 D03382 D00515
D00131 D00309 D00334 D00429 D00874 D03581 D00699 D03628 D00146 D00179 D00202
D00208 D00215 D00221 D00237 D00257 D00260 D00263 D00265 D00268 D00271 D00285
D00286 D00353 D00358 D00439 D00458 D00479 D00489 D00511 D00518 D00538 D00598
D00600 D00605 D00621 D00648 D00660 D00661 D00673 D00675 D00708 D00714 D00732
D00845 D00848 D00865 D00896 D00909 D00937 D00944 D00945 D00961 D01010 D01011
D01062 D03110 D03111 D03138 D03148 D03159 D03173 D03207 D03267 D03269 D03280
D03296 D03310 D03322 D03327 D03331 D03332 D03333 D03336 D03343 D03351 D03352
D03354 D03355 D03362 D03364 D03365 D03367 D03368 D03369 D03374 D03375 D03376
D03379 D03381 D03418 D03424 D03456 D03491 D03523 D03532 D03533 D03540 D03545
D03550 D03577 D03597 D03598 D03600 D03601 D03602 D03603 D03604 D03605 D03606
D03607 D03610 D03612 D03614 D03615 D03616 D03664 D03665 D03672 D03673 D03675
D03678 D03682 D03684 D03706 D03720 D03721 D03722 D03726 D03732 D03761 D03763
D03816 D03833 D03843 D00145 D00196 D00201 D00204 D00205 D00206 D00207 D00216
D00219 D00274 D00275 D00276 D00281 D00287 D00410 D00438 D00447 D00496 D00527
D00596 D00610 D00674 D00842 D00899 D00967 D01045 D03102 D03113 D03117 D03131
D03285 D03301 D03313 D03325 D03326 D03328 D03348 D03360 D03366 D03371 D03378
D03431 D03474 D03536 D03585 D03595 D03666 D03667 D03671 D03676 D03679 D03681
D03783 D00117 D00121 D00138 D00141 D00150 D00165 D00167 D00170 D00171 D00183
D00218 D00253 D00256 D00259 D00261 D00267 D00273 D00311 D00313 D00315 D00328
D00378 D00383 D00385 D00431 D00441 D00448 D00461 D00606 D00607 D00614 D00615
D00617 D00618 D00623 D00681 D00716 D00830 D00860 D00861 D00862 D00867 D00871
D00872 D00873 D00901 D00935 D00955 D00988 D03118 D03120 D03132 D03161 D03175
D03176 D03189 D03194 D03270 D03361 D03388 D03389 D03390 D03404 D03405 D03408
D03413 D03414 D03420 D03425 D03428 D03429 D03430 D03483 D03512 D03515 D03522
D03525 D03530 D03565 D03583 D03586 D03591 D03592 D03596 D03629 D03641 D03642
D03647 D03649 D03740 D03769 D00154 D00177 D00190 D00234 D00235 D00245 D00247
D00262 D00264 D00443 D00457 D00462 D00536 D00612 D00613 D00650 D00667 D00869
D00870 D00914 D00930 D00984 D00994 D01067 D03011 D03265 D03284 D03297 D03372
D03406 D03407 D03409 D03573 D03594 D03646 D03668 D03674 D03689 D03738 D03805
D00143 D00590 D00828 D03123 D03141 D03209 D03212 D03417 D03527 D03685 D00941
D00723 D00483 D00498 D00719 D00728 D01008 D01056 D03453 D03657 D03719 D00394
D03251 D03852 D00288 D00736 D03377 D03457 D03476 D03477 D00308 D00905 D03450
D03465 D00122 D00499 D00622 D00730 D00807 D00812 D00829 D00878 D00943 D03502
D03503 D03505 D03526 D03531 D03554 D03567 D03691 D03725 D03744 D03754 D00156
D00424 D00535 D00818 D00839 D00879 D00970 D01051 D03524 D03699 D00113 D00434
D00868 D03105 D03260 D03528 D03659 D03696 D00950 D00954 D00958 D00959 D03660
D03661 D03728 D03756 D00332 D00722 D00933 D00949 D00322 D01015 D03609 D00508
D03394 D03396 D03290 D03717 D01039 D01040 D00240 D00756 D00934 D00946 D01018
D03433 D00126 D03397 D00272 D00971 D03171 D00341 D03818 D00692 D00504 D00680
D00974 D03737 D00478 D00645 D01012 D03658 D03104 D00533 D00982 D00507 D03762
D03289 D03403 D03475 D00279 D00688 D00521 D03707 D00278 D00407 D00449 D03385
D03392 D03432 D03460 D00128 D00277 D00529 D00534 D00634 D00643 D00690 D00980
D00981 D01014 D01016 D03416 D03448 D03454 D03470 D03472 D03479 D03727 D03749
D00419 D00644 D00682 D00721 D03703 D00684 D01013 D00663 D00486 D00528 D00583
D00641 D00647 D00672 D01052 D01053 D01055 D03164 D03182 D03191 D03198 D03231
D03249 D03275 D03282 D03294 D03299 D03349 D03357 D03383 D03393 D03395 D03398
D03399 D03419 D03426 D03608 D03631 D03736 D00474 D03439 D00475 D00635 D00713
D01017 D03230 D03410 D03630 D03634 D00939 D00157 D00338 D00686 D03179 D03537
D03651 D03652 D01076 D03438 D03443 D03690 D00687 D00917 D00514 D03618 D03686
D03808 D00876 D01046 D03656 D00225 D00677 D03819 D00646 D01070 D01073 D03582
D03611 D03786 D03789 D03790 D03791 D03792 D03830 D03848 D03850 D03851 D00217
D00153 D00222 D00248 D00591 D00599 D03155 D03192 D03201 D03140 D03637 D03386
D00321 D03135 D03356 D00432 D00473 D03387 D03580 D03624 D00799 D00964 D00966
D00440 D00911 D03359 D03363 D03373 D03782 D00466 D00611 D00898 D00975 D03200
D03486 D00409 D00494 D00659 D03858 D03547 D03853 D00501 D03543 D03552 D03555
D03584 D03599 D00446 D00500 D00890 D03293 D03648 D00951 D03796 D03827 D03846
D03860 D00442 D01050 D01057 D03688 D00453 D00452 D03116 D03521 D00101 D00471
D03662 D00436 D00755 D00841 D00846 D00922 D00956 D01061 D03108 D03250 D03412
D03473 D03482 D03504 D03508 D03518 D03535 D03632 D03700 D00151 D00734 D00750
D00877 D03170 D03286 D03734 D03772 D00524 D00603 D00604 D00324 D00417 D00428
D00601 D00602 D00642 D00815 D00831 D00875 D00880 D00881 D01059 D03716 D03785
D03836 D00238 D00932 D03444 D03553 D03619 D00148 D00213 D00301 D00510 D00597
D00833 D01058 D03106 D03464 D03467 D03735 D03593 D01047 D00729 D00851 D00915
D00999 D03350 D03645 D00369 D03653 D00584 D00657 D00952 D00280 D00342 D03587
D01071 D03773 D00624 D01069 D00595 D01077 D03520 D03588 D03590 D00103 D00155
D00166 D00180 D00250 D00251 D00255 D00325 D00331 D00430 D00444 D00454 D00464
D00470 D00476 D00497 D00509 D00513 D00522 D00526 D00547 D00549 D00553 D00555
D00556 D00557 D00559 D00585 D00671 D00691 D00753 D00843 D00852 D00863 D00893
D00913 D01030 D01031 D01072 D03246 D03248 D03314 D03435 D03513 D03548 D03556
D03575 D03576 D03578 D03798 D00294 D00382 D00384 D00668 D01044 D00544 D00545
D03680 D03730 D03731 D03807 D00102 D00379 D00381 D00386 D00387 D00433 D00540
D00586 D00609 D00662 D00683 D00766 D00844 D00864 D00957 D01043 D01048 D01054
D03005 D03114 D03125 D03190 D03245 D03252 D03271 D03272 D03277 D03278 D03279
D03562 D03589 D03613 D03633 D03640 D03650 D03698 D03708 D03710 D03739 D03741
D03771 D03800 D03802 D03809 D03810 D03811 D03839 D00233 D00517 D00523 D00525
D00542 D00822 D03199 D03241 D03484 D03340 D03311 D00343 D00630 D00669 D00793
D00800 D00973 D00990 D03236 D03242 D03449 D03480 D03487 D03781 D03806 D03345
D03276 D03330 D03339 D00193 D00197 D00303 D00304 D00306 D00307 D00349 D00356
D00359 D00367 D00372 D00375 D00412 D00465 D00490 D00495 D00552 D00558 D00566
D00571 D00574 D00580 D00581 D00638 D00665 D00703 D00735 D00745 D00751 D00767
D00769 D00776 D00788 D00795 D00809 D00889 D00938 D00987 D00989 D01007 D03144
D03273 D03283 D03347 D03370 D03461 D03466 D03489 D03511 D03541 D03621 D03787
D03815 D03822 D03826 D03829 D00592 D00480 D00701 D00725 D00801 D00884 D00326
D00337 D00347 D00411 D00469 D00631 D03825 D00720 D03264 D03497 D03514 D03516
D03559 D03560 D03561 D03563 D03564 D03566 D03568 D03569 D03570 D03571 D03572
D03574 D03579 D00492 D00139 D00451 D00992 D00996 D01004 D03733 D03801 D00485
D00502 D00636 D00707 D00718 D03137 D00258 D00350 D00351 D00364 D00554 D00903
D00910 D01020 D03195 D03455 D03458 D00168 D00186 D00203 D00224 D00242 D00249
D00310 D00317 D00388 D00445 D00561 D00582 D00768 D00772 D03149 D03274 D03341
D00632 D03261 D03485 D03509 D00173 D00236 D00244 D00330 D00339 D00340 D00694
D00695 D00758 D00760 D00765 D00775 D00778 D00782 D00794 D00995 D03133 D03324
D03334 D00182 D00254 D00398 D00649 D00742 D00810 D00819 D03153 D03187 D03202
D03213 D03215 D03220 D03223 D03232 D03259 D03320 D03335 D03447 D03549 D03759
D03764 D03774 D03777 D03813 D00415 D00627 D00640 D00656 D00797 D00968 D01033
D01037 D03129 D03130 D03235 D03499 D00189 D00192 D00195 D00200 D00209 D00366
D00393 D00468 D00953 D00972 D03169 D00418 D00481 D00487 D00563 D00570 D00573
D00575 D00579 D00666 D00816 D01024 D03160 D00178 D03152 D03225 D03255 D03337
D03462 D03463 D03517 D03534 D03558 D00421 D00516 D00543 D00920 D01009 D01035
D03304 D03459 D00314 D00142 D00395 D00405 D00413 D00425 D00562 D00564 D00567
D00693 D03107 D03115 D03122 D03185 D03211 D03222 D03224 D03228 D03229 D03253
D03256 D03298 D03309 D03338 D03353 D03380 D03415 D03446 D03451 D03452 D03755
D03799 D03803 D03812 D00300 D00158 D00344 D00352 D00397 D00403 D00460 D00541
D00548 D00888 D00892 D00894 D03240 D03436 D03437 D03821 D00176 D00316 D00423
D00435 D00791 D00826 D00897 D00912 D03145 D03214 D03346 D00711 D00712 D00726
D00727 D00887 D00228 D00246 D00302 D00399 D00493 D00653 D00655 D00963 D00978
D00336 D00392 D00420 D00422 D00625 D00633 D00639 D00652 D00763 D00813 D00993
D03126 D03162 D03167 D03227 D03254 D03288 D03300 D03344 D03820 D00293 D00346
D00503 D00512 D00531 D00546 D00565 D00741 D00749 D00752 D03157 D03165 D03268
D03748 D03751 D03775 D01019 D03219 D00977 D00292 D00296 D03147 D03234 D03302
D03421 D03501 D00568 D00577 D00923 D00931 D00936 D03136 D03197 D03217 D03218
D03221 D03243 D03308 D03316 D03318 D03321 D03329 D03500 D03551 D03622 D03623
D00108 D03747 D03750 D03752 D00685 D00696 D00733 D00777 D00781 D00787 D00789
D03319 D03323 D03445 D03510 D00223 D00239 D00241 D00282 D00629 D00790 D01034
D01036 D03814 D00199 D00214 D00220 D00318 D00373 D00705 D00770 D00774 D00780
D00825 D00908 D00919 D00927 D00194 D00357 D00484 D00537 D00539 D00616 D00628
D00651 D00698 D00702 D00740 D00744 D00771 D00773 D00779 D00783 D00784 D00785
D00792 D00821 D00960 D00962 D01000 D01002 D01005 D01006 D01025 D01027 D03184
D03186 D03237 D03266 D03291 D03317 D03542 D03620 D03638 D03768 D03784 D01023
D01026 D01028 D01029 D03193 D00134 D00243 D00626 D00654 D00670 D00739 D00747
D00748 D03128 D03139 D03146 D03150 D03151 D03158 D03168 D03174 D03178 D03180
D03238 D03257 D03258 D03262 D03263 D03292 D03305 D03306 D03434 D03496 D03538
D03757 D03760 D03767 D00455 D00467 D03778 D00230 D00231 D00762 D00764 D00983
D01003 D01022 D03127 D03797 D03823 D03824 D00105 D00127 D00132 D00135 D00136
D00185 D00187 D00335 D00355 D00532 D00569 D00572 D00576 D00700 D00710 D00746
D00754 D00759 D00761 D00806 D00820 D00840 D00847 D00850 D00858 D00906 D00907
D00918 D00928 D00986 D01042 D01060 D01074 D01075 D03281 D03312 D03315 D03471
D03481 D03506 D03519 D03539 D03544 D03546 D03714 D03746 D00227 D00991 D00997
D03203 D03303 D00658 D00107 D00114 D00163 D00175 D00184 D00188 D00198 D00210
D00226 D00232 D00252 D00291 D00295 D00297 D00299 D00305 D00312 D00319 D00327
D00333 D00345 D00354 D00362 D00389 D00391 D00396 D00400 D00402 D00404 D00406
D00450 D00459 D00491 D00506 D00550 D00551 D00560 D00697 D00704 D00706 D00798
D00802 D00803 D00804 D00814 D00817 D00824 D00835 D00900 D00904 D00924 D00925
D00926 D00929 D00969 D03103 D03134 D03142 D03156 D03163 D03166 D03177 D03188
D03205 D03208 D03210 D03226 D03411 D03529 D03557 D03627 D03635 D03636 D03639
D03663 D03669 D03670 D03687 D03693 D03694 D03697 D03701 D03705 D03709 D03711
D03713 D03718 D03723 D03729 D03745 D03753 D03758 D03766 D03770 D03788 D03817
D00855 D01041 D00426 D00519 D00593 D00856 D00859 D03468 D03469, and D03869
RECALLING FIRM/MANUFACTURER
Recalling Firm: GE
Healthcare,
Manufacturer: GE
Medical Systems, Kretziechnik GmbH & Co OHG, Zipf, Austria.
REASON
Inaccurate dimension
measurements in M-Mode when pan-Zoom is activated in GE Voluson® E8 Ultrasound
Systems. Of particular concern are potential inaccuracies of fetal cardiac
measurements that may impact patient safety.
VOLUME OF PRODUCT IN
COMMERCE 1,637 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
Synchron Acetaminophen (ACTM) Reagent, Part Number 472169. ACTM
Reagent when used in conjunction with SYNCHRON LX System(s), UniCel DxC 600/800
Systems and SYNCHRON Systems Drug Calibrator 2 set, is intended for quantitative
determination of Acetaminophen concentration in human serum or plasma. CODE
Lot numbers: M703276 and
M702524
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Beckman Coulter, Inc., Brea, CA,
Manufacturer: Beckman Coulter, Inc., Fullerton, CA. REASON
Acetaminophen reagents (lots #M702524
& M703276) manufactured with contaminated heparin has shown a negative bias
in performance between the assay made with contaminated and uncontaminated
heparin.
VOLUME OF PRODUCT IN COMMERCE 7,764 set
kits
DISTRIBUTION Nationwide and Canada
PRODUCT
ACIST" BRACCO, AT P54 AngioTouch Kit, SKU # 014644, Sterile. Made in Mexico. Catalogue
No: 800608-013 intended to be used for the controlled infusion of radiopaque
contrast media for angiographic procedures,
CODE Lot numbers: 0368H, 0368J, 0378L, 0388F,
0388N, 0388V, 0498F, 0498H, 0508B, 0528P, 0528W, 0578N, 0588J, 0588K, 0598T,
0848K, 0848L, 0878M, and 0918N
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Acist Medical Systems, Eden
Prairie, MN,
Manufacturer: Nypro
Healthcare Baja, Tijuana, Mexico. REASON Some of the sterile package seals of AT P54
AngioTouch Kit were breached. Breached package seals could compromise product
sterility, which could potentially lead to patient infection.
VOLUME
OF PRODUCT IN COMMERCE 33,980
kits
DISTRIBUTION Nationwide, Canada, Brazil, Japan,
China, Korea, Thailand, Hong Kong, and Australia
PRODUCT
a)
Horizon Pump Set w/150 ml burette w/15 um filter and Ultrasite inj site, 2
Ultrasite inj sites, B/C valve 120 in. Item/Catalog number 375040. The product
is shipped 20 units per carton. The product is used with the Horizon Pump,
Horizon NXT Pump, and Outlook Safety Infusion System,
b) Adult Metriset w/Cassette 2 inj sites, LL 120 in. Item/Catalog number 375043. The product is shipped 20 units per carton. The product is used with the Horizon Pump, Horizon NXT Pump, and Outlook Safety Infusion System,
c) Safeline Metriset w/Cassette, inj sties, clamps LL 114
in. Item/Catalog number 375122. The product is shipped
20 units per carton. The product is used with the
Horizon Pump, Horizon NXT Pump, and Outlook Safety
Infusion System,
d) Metriset Burette Set w/Horizon
Pump, Ultrasites, 120 in. Item/Catalog number 375150.
The product is shipped 20 units per carton. The product is used with the
Horizon Pump, Horizon NXT Pump, and Outlook Safety
Infusion System,
e) Burette Set w/150 ml Burette
w/15 um filter & Ultrasite inj site, Ultrasite inj site, 88
in US1540. Item/Catalog number 375137. The product is
shipped 20 units per carton. The product is for use
after activation of shutoff valve (re-floating of disk),
f) Add-On Burette Set with 150 ml burette and Ultrasite Injection Site
without automatic shutoff. Item/Catalog number 375111. The product is shipped 20
units per carton. The product is for use after activation of shutoff valve
(re-floating of disk),
g) Add-On Burette Set with
150 ml burette 7 Ultrasite Injection Site with automatic shutoff, 20 in US1525M Metriset Add-on Burette Set.
Item/Catalog number 375059. The product is shipped 20
units per carton. The product is for use after activation of
shutoff valve (re-floating of disk),
h) Burette Set w/150 ml burette w/15 um filter & inj
site, inj site, with automatic shutoff 87 in.
Item/Catalog number 375113. The product is shipped 20 units per carton. The
product is for use after activation of shutoff valve (re-floating of disk),
CODE
a) Lot numbers 60999552 exp
4/30/2011, 00VL986720 exp 1/31/2013, 00VL986732 exp
1/31/2013, and 60999551 exp 3/31/2013;
b) Lot number 60998897 exp 3/31/2013;
c) Lot number 60998903 exp 3/31/2013;
d) Lot number 60998893 exp
3/31/2011;
e) Lot number 60999539 exp 3/31/2013;
f) Lot number 60999546
exp 3/31/2013;
g) Lot number 60999544 exp 3/31/2013;
h) Lot number
00VL987139 exp 12/31/2012
RECALLING
FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc., Allentown,
PA, Manufacturer: B. Braun, Santo Domingosanto
Domingo, Dominican Republic.
REASON Incorrect burette was packaged with the
product.
VOLUME OF PRODUCT IN COMMERCE 29,180
units
DISTRIBUTION Nationwide
PRODUCT
Kwiktrak Gate System; the rail system used with the Maxi Sky 600
Ceiling Patient Lift; The Kwiktrak Gate System consists of part 700.11560 -
Kwiktrak gate motor box (serialized), part 700.11550 - Kwiktrak gate fixed box,
part 700.11505 - Kwiktrak gate combination kit (includes 2 x 700.11550 and 2 x
700.11560), and part 700.11500 - Kwiktrak gate (includes 1 x 700.11550 and 1 x
700.11560). The equipment is intended for transferring lifts from one system
track to another.
CODE Serial numbers: GA-1304-0001 to
GA-2608-1374, all units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Arjo, Inc., Roselle, IL,
Manufacturer:
B.H.M. Medical, Inc., Magog,
Canada. REASON There
is a possibility that the Kwiktrak Gate System could malfunction, resulting in
the gate locks opening even though the corresponding tracks are not properly
aligned.
VOLUME OF PRODUCT IN COMMERCE 230
units
DISTRIBUTION Nationwide
PRODUCT
a) Innova 2000; The principle system components include a C-arm,
image acquisition, processing and archiving capabilities. Indicated for use in
generating fluoroscopic images of human anatomy for vascular angiography,
diagnostic and interventional procedures, and optionally, rotational imaging
procedures. Also indicated for generating fluoroscopic images of human anatomy
for cardiology, diagnostic, and interventional procedures. Intended to replace
fluoroscopic images obtained through image intensifier technology,
b) Innova 2100IQ (The Digital Fluoroscopic Imaging System consists of an a monoplane positioner, a vascular or cardiac table, an X-ray system and a digital detector) Indicated for use in generating fluoroscopic images of human anatomy for vascular angiography, diagnostic and interventional procedures, and optionally, rotational imaging procedures. Also indicated for generating fluoroscopic images of human anatomy for cardiology, diagnostic, and interventional procedures. Intended to replace fluoroscopic images obtained through image intensifier technology,
c) Innova 3100 / 3100 IQ, Cardiovascular Imaging System, GE Healthcare,
Waukesha, WI 53188 (The system consists of an a monoplane Indicated for use in
generating fluoroscopic images of human anatomy for vascular angiography,
diagnostic and interventional procedures, and optionally, rotational imaging
procedures. Also indicated for generating fluoroscopic images of human anatomy
for cardiology, diagnostic, and interventional procedures. Intended to replace
fluoroscopic images obtained through image intensifier technology,
d) Innova 4100 / 4100 IQ , GE Healthcare, Waukesha, WI 53188
(The system consists of an a monoplane positioner, a vascular or cardiac table,
an X-ray system and a digital detector) Indicated for use in generating
fluoroscopic images of human anatomy for vascular angiography, diagnostic and
interventional procedures, and optionally, rotational imaging procedures. Also
indicated for generating fluoroscopic images of human anatomy for cardiology,
diagnostic, and interventional procedures. Intended to replace fluoroscopic
images obtained through image intensifier technology,
CODE
a) Lot numbers: 201996LAB2 201996LAB3
202745VACATH2 203576NI1 205783BCL3 205783BCL4 206598INNOVA1 207626CL1 207755CL1
207795CL1 207795CL2 207871CL6 208381INNOVA 208523CATH 209526ICATH1 210292CATH1
210297NECATH1 212746J412 213726CATH 213977INNOVA1 213977INNOVA4 214320INNOVA
214590INNOVA 214820INNOVA3 214820INNOVA4 214947CMINNOVA 215448INNOVA
215728INNOVA 215861LC2 216778LABA 217258CATH 217383CCL3A 217464INNOVA 219465CL1
219465EP 219757INVA 219932DCL1 219947EP 228INNOVA 229259INOV1 229259INOV2
229386INOV1 239436CATH2 239939CLB 251435ICV1 251435ICV4 252443NGIN1
253627INNOVA2 253627INNOVA3 254519I2K 256341IN1 256386IN1 256880IN1
262243INNOVA1 262255INNOVA1 262569INNOVA 281338INA 281351TINNOVA 281440LAB2
281440LAB3 281540NECATH 281893INNOVA 301891CATH1 302421INNOVA 303320CL1
303320CL2 303369CL2 303425HCL1 303673CL1 303715CL1 303730CL1 303778CL1 303778CL2
305223IN1 305223IN2 305325CCL3 305325CL4 305585CL2 305585CL3 308865PHI
309454BINNOVA 309691HCL1 309691PINNOVA 310423INNOVA3 310423INNOVA4 310423INNOVA5
310423INNOVA7 310540INNOVA 312792RINOV2 313343LC 314569JC1 314966DCL2A 315448RM1
315448RM2 315448RM3 316268INNOVAB 316268INNOVAEP 316689INNOVA1 317621EP2
317621INNOVA1 317621INNOVA2 317621INNOVA3 317818MDI915 317887INNOVA1
317887INNOVA2 318448INNOVA 318449INNOVA1 321HCL4 321HCL5 321PBCL1 330375LAB1
330837INNOVA 336716BCL1 336832MCCL1 336832MCCL3 337289INNOVA 352344CATH1
352INVCATH 361788NOVA 386719CATH 401274IN3 402280CIN1 402280CIN2 404265AMC2
404305SF1 404686CRI1 404686CRI2 404712EI1 405272SCL4 407321INCL1 407518CL1
407518OPCL 408259INV 410337INNOVA1 410337INNOVA3 410337INNOVA4 410337INNOVA5
410543CATH1 410543CATH6 410614CV7 412232B 412367LAB1 412367LAB3 412623LABB
412623LABC 412623LABI 412647LABA 412647LABB 412647LABC 412647LABD 412784C1
413748INNOVA 414219INNOVA 414291CL3 414649INNOVA 414805INNOVA2 414961INNOVA
415206CATH 415750SCL1 415750SCL2 416284INNOVA 416469INNOVA 417269SCLB 417269SCLC
417885JCL1 417885JCL2 417885JCL3 417885JCL4 418656CNOVA1 418656CNOVA2 419227CL3
419526INNOVA3 419526INNOVA4 423493PCL3 423495CHIRM1 423559BCL1 423844CCL2
440835INNOVA 443481INOVA1 443849INNOVA 478765CTH1 478765CTH2 480512IN1 480512IN3
480728LAB1 480821IN1 501484LC3 501686UAINNOVA 502587L2 502587LAB3 502587LAB5
503215INNOVA 503370INNOVA 504391INNOVA 504447INNOVA 504903INNOVA 505983CATH
508798INC2 508856IN3 508856IN4 508856IN5 508856IN6 509473DR5 509473DR6 509473DR7
509946CATH1 512341RI 512447SI 512447SI2 513559INNOVA 513853INNOVA 513861INNOVA
514376CARDIO 514468BINNOVA 514843AINNOVA 516562INNOVA3 516562INNOVA5 516663EP3
516663INNOVA1 518243EP1 518525LAB2 519663INNOVA 520296CATH1 530244XC3
540932INNOVA 541282CV1 541382CV1 541382CV2 541686SPR3 561548CL1 561548CL2
561548EP 561798CATH1 561798CL1 562491INNOVA 563244CATHLAB1 563244CATHLAB2
563421CATHLAB1 563421CATHLAB2 563421CATHLAB4 563421CATHLAB7 570969CATH
573472CATH 573632CRC1 573686CL1 573761SMC1 601268INNOVA1 601553CL1 601553CL2
601968INNOVA 602239LAB1 602588INNOVA 603228CCL2 603433PLC1 603650CATH3
603668CLCB 604682INNOVA 605719INNOVA1 605719INNOVA2 606439INNOVA 608324CATH
609267INNOVA 609652CATH2 609653INNOVA 609757IN2000 610270INNOVA 610431CL1
610431CL2 610447CL2 610645CL5 610648INNOVA 610954INNOVA 610954INNOVA2
610988INNOVA1 610988INNOVA2 610988INNOVA3 612273INNOVA1 612467INNOVA1
613548INNOVA2 614293INNOVA1 614293INNOVA2 614293INNOVA3 615222STCL3 615222STCL5
615284CV2 615316INOV2 615327CV1 615327CV2 615495MCL5 615768CV1 617754IN1
617754IN2 617754IN3 617754IN4 618241GSI 619260INNOVA 619340VA7 619457INNOVA3
619691INNOVA 619739INNOVA 623848LAB1 626915INNOVA 631376INNOVA 636916SPCL1
636947JCL3 650696INV1 650723SC6 651582INN1 661949INNOVA 701234GE2 701234GE3
701857I2K 702388INNOVA1 702564INNOVA 702731INNOVA 702731INNOVA2 702731INNOVA3
704487CMIN1 706651CCL 706721CCL 706774CCL2 706774UC6 707546INNOVA 708202VA2K
708333INOVA 708352L2K 708425INNOVA1 708597EP 713359INA 713359INB 713776MINNOVA
713794LAB10 713794LAB3 713794LAB4 713897CIN 713964BIN 714229INNOVA 714533INNOVA
714953INNOVA 714999INNOVA 716859BGEP 717270INNOVA1 717270INNOVA2 717544CATH1
717544CATH4 717763INNOVA 717763INNOVA2 717782INNOVA 718226INNOVA1 718226INNOVA2
718283INNOVA1 718283INNOVA2 718780CATH1 718918CATH1 718963INNOVA1 719560HCL2
719776CL1 719776CL2 720225CL1 724284CL 724773C2 724773C3 727521CATH3 727725CATH1
727825CATH 727869CATH1 732557INNOVA 732776CATH1 732776CATH5 740439CATH
740454INNOVA1 740454INNOVA2 757886CATH1 760633INNOVA 760940INNOVA1 770228GC1
770991INNOVA 773702INNOVA 773878SWGCATH1 773878SWGCATH2 773878WCL 773884HC2000
773STJINNOVA200 775770CATH1 775982CATH3 785354HRT1 785354HRT2 801299INNOVA
801373CATH1 801373CATH2 801373EP 801429INNOVA 801479INNOVA 803256CL6 803256PCL3
803256PEP1 803256PEP3 803329CL20 803641CCL 804285CATH4 804320CATH1A 804320CATH3A
804320CATH5 804320CATH6 804764INNOVA 805497INNOVA1 805497INNOVA2 806354INNOVA1
806354INNOVA2 808242INNOVA 812265L1 812283IN20 812376CL1 812450CATH2 813615CL2
814534C1 814765CATH 815226INN1 816932HRT2 816932SLHEART8 816985NKCI2
817255NH2000 817329BGINNOVA 817347MPINNOVA 817465ARINNOVA 817877INNOVA
817922INNOVA 818502INNOVA1 819563CINNOVA1 819563CINNOVA2 828262CL 828298CCL
828322FIN 831462CL1 831624INV1 832355SMIN 843339INNOVA 843577CL1 843674INNOVA
843692INNO 850325INNOVA1 850325INNOVA2 850494INNOVA 850494INNOVA2 850862INNOVA1
850862INNOVA2 856342INNOVA 859233INNOVA1 859233INNOVA2 859276INNOVA 859313CL6
859313CL7 860210CV 860358CV 861EP2 864261CL1 864261CL2 864455GMIN1 864455GMIN2
865218CCL1 865481CCL1 865541CCL1 865541CCL2 865541CCL4 865693CCL5 870508LAB3
901384CV3 901726R2 901757CV2 901765CV1 903315INN 903798WINN 903870INN
904202CATH1 904202CATH2 905895INNOVA1 905895INNOVA2 905895INNOVA3 908668INNOVA
909865INNOVA1 909865INNOVA2 909CH2000 910343NHIN2 913317SLSHEART1 913791OINCATH
918307SHIN1 918307SHIN2 918341CI 918494IN2A 918744JI1 918744JI2 918744JI3
919934JCL 920288CATH1 920288CATH2 920729INNOVA 920738INNOVA 920926CATH1
928639IN1 936266CL2 936539CL2 937208INNOVA1 940384INNOVA2 940764INOV1
940764INOV2 940764INOV3 940898INN 941483INNOVA1 941483INNOVA2 949753INNOVA
952993INNOVA 952993INNOVA3 952993INNOVA4 956389INNOVA 956632INOVA 970350CL3
972335INN 972394INNOVA 972540INN 972969INNOVA 973365CATH 973365LAB1 973971EP2
973971LAB1 973971LAB2 973971LAB4 973971LAB5 973972LAB1 973972LAB2 973972LAB3
985867INNOVA1 985882INNOVA AL9INNOVAVAN CSI214 DR2000 DUCK ECXV1401A ECXV1406C
FHORLCL2 FHORLCL4 FHORLCL5 FHORLCL6 FHVIN2000 FLGRCATH1 FLGRCATH2 FWCL3772
KMCINNOVA LIJ016133 LVEPINOV5 LVINOV1 LVINOV2 LVINOV3 MCTH072 MCTHSC1 MCTHSC2
MOUSE WCATHLAB2000 2548244 2577797 2590608 0002733004A 920020937 0920020937A
0920020937B 202745GEMNET 262548INNOVA 604875INNGEC 631968EP1 843577CL1GP, and
ECXV1407I;
b) Lot numbers: 201447LAB1 202782LABC 2035762100 208227CATH1
208367INNOVA 208381CCL1 212305CATH1 212604INNOVA1 214947MINNOVA 214947MINNOVA2
215453INNOVA21 217383CCL2A 219932DCL2 229228INNOV21C 239436CATH4 251435ICV3
251435ICV7 252384CATH1 253627INNOVA1 262255INNOVA2 262687CL2 303369HCL4
303425CL3 303788CL1 303839CL2 304424INNOVA 305364P2100 305682IN2 308865GIN1
310825INNOVA21 317355INNOVA3 318448INNOVA3 330363LAB3 330375LAB2 336538ARCL
336832MCCL6 360456XCL4 402559UCC 402559UCD 405604D2100 408559INV1 409938INV21
410337INNOVA6 410554INNOVA1 410554INNOVA2 410554INNOVA3 410554INNOVA4 4107872100
412367LAB2 414291CL2 414649INNOVA2 416480INNOVA 416864INNOVA 416864INNOVA2
417269SCLA 417347FCV2 417347FCV4 423495MCATH1 4436432100 501257VALAB1
505848CATH1 505848EP 508335INNOVA 508856IN21 508941IN21 509575YM2100
516562INNOVA2A 516562INNOVA6 516562INNOVA7 516632INNOVA1 518243LAB1 518243LAB2
541732CV2 541743CL3 561548ET2 570476INNOVA21 573256MHC 573761SMC2 573815BCR2
573815BCR3 573815BCR4 574535IN21 602239CLAB2 604682INNOVA1 604682INNOVA2
604875AINNOVA1 604875AINNOVA2 607737CL1 608775NOVA1 608775NOVA2 610250INNOVA1
610250INNOVA3 610776INNOVA21 610983INNOVA2 612273INNOVA2 615284CV3 615342CV3
615446CV1 615515OPCL 617636CL1 619457INNOVA6 619552INNOVA2 630856H2100 650369SV4
65049321 651582IN3 661327INNOVA1 661327INNOVA2 7023602100 704384CL21 706291CLIN1
713375U2100 713794LAB1 717217INN21 717544GECATH2 717544GECATH3 718470EP
718780CATH3 727521CATH2 727521CATHOP 727869CATH3 727869CCL2 727869EP5
727942CATH2 732324INN1 732776CATH4 732923INN 770HMCCL1 775982INN2100 781340IN1
781340IN3 785354HRTEP 803256PCL5 804764CATH2 8053702100 808547QCV1A 808547QCV3A
812238UN21 813615CL1 813615CL8 813615CL9 813615EP3 814452EP 8157412100
815759CARDIAC1 816861KCVAI2 817329BG2100 8184092100 828213IN21 843692CATH3
843724CL1 843724CL2 843724CL3 843724EP1 843797EP 843797TCL1 845365V13 845368LAB1
845368LAB2 847316INNOVA1 847316INNOVA2 856853IN2100 857307IN421 858554INNOVA2
858554INNOVA3 864255SFCL1 864255SFCL2 865693CCL 865693CCL2 865977CCL 901765EP
904597CATH 905848INNOVA1 910343EP1 910343EP2 910671INOV21 916781INNOVA2
9284532100 937208INNOVA2 949250I21 954735CL2 954987CCL7 954987CCL8 954987CL4
970350CL2 9704CHINNOVA 973579LAB1 985898INNOVAA 985898INNOVAB CM2100 ECXV1406F
FHOMEP LVINOV7 PRESBYDEP RPINNOVA2100 2637041 2680771 2683172 2686112 2706718
2710562 2713664 2713687 2715023 2718602 2729712 2730402 2730405 2730406 2731313
2731570 2731573 2731583 2738012 2741780 2749861 2754702 2755150 2756171
262687CL1 316689MP 541677MINNOVA2 541789CV1 609267IN2100 609757IN2100
610645LAB10 760940INNOVA2, and 828315FIN2;
c) Lot numbers: 2652143
2014183100 201541LAB2 201996LAB1 2035763100 2035763100A 2036883100 205783BCL5
205877CCL1 205877CCL2 207351YCL1 207662CL4 207879CL131 208227CATH2
209334LINNOVA1 214324INNOVA2 214590PH3100 215335INNOVA1 215576INNOVA1 219326IN31
2197573100 219877IN2 219877IN31 228818VASC 239436CATH3 239513CRLAB1 239939CLA
251435ICV6 251633PROV 253968INNOVA 254742KDCL1 262687CL3 270688INN 281420LAB1
281420LAB23100 281440CL3 3027443100 303425CL4 303629CL4 303629EP 303788CL2
305364P3100 308865GIN2 309691P3100 310319SM3100 310423INNOVA1 310825INNOVA31
312STMNAZ3100 313593IC1 313593IC2 314525STACL2 314768SMCL1A 314768SMCL3
316268INNOVAA 316651INNOVA31 316962WCVC1 316962WCVC2 318448INNOVA2 318449INNOVA2
318798CL1 325428CATH1 325428CATH3 334418CL 336832MCPV 337374INNOVA 352333CATH1
352333CATH2 360456XCL3 361857CATH1 361980INNOVA2 402559UCB 404686CRI3 405272SCL2
405372S3100 405604D3100 405610NW3100 405840OIC3100 406447VAIN3 406543IN3
409899LAB3 4103323100 4103623100 412437INNOVA 413447CATH 413540IN1 413582C3100
414447CL1 414647CL1 414649CL3 414649CL4 414805INNOVA1 415925INV1 417269SCLD
417347FCV5 417885JCL7 417885JCL8 423495MCL6 423844CCL1 478274CTH1 479441SP3100
480728LAB2 480821IN2 502587LAB1 502587LAB4 502852INNOVA 5033703100 5034353100
507385INN3100 508856IN2 508941IN1 509946CATH2 510797INV8 512901NI3100
516562INNOVA8 516562INNOVA9 516632INNOVA2 516663INNOVA1A 516663INNOVA2
518525LAB1 530244XC106 540953INNOVA 541382CV3 541677MINNOVA1 541743CL6
541MWHINNOVA 561266IN31 561548CL4 570476INNOVA31 573458CL1 573632CRC2 573815BCR1
573882UMC1 580548B3100 6012883100CV2 601553CL3 601883CL1 602239LAB4 602239LAB6
602266LAB2 603421PCL 603580ECL1 608524NOVA 609757IN3100 610447CL1 610526LAB1
610526LAB2 610595CL1 6106483100 610770INNOVA31 610891CL1 610954INNOVA1
610983INNOVA1 615338CV2 615769SKYCV2 616392INNOVA 617732IN9 617789IN1
618241GSI3100 619340VA8 619457INNOVA5 619482INNOVA1 619541INNOVA31 619552INNOVA1
620225INNOVA31 630312B31 630856H31 631376EP 631968INNOVA2 631968INNOVA3
650369SV3 65049331 6619483100 662377CV2 662377CV4 671GMHAINVA 678957INNOVA
7018573100 7022333100 702616INNOVA 7028533100 7028803100A 704355RM2 704384CATH2
704384PHMCATH 704878CL31 706481CCL 706774CCL4 706774CCL5 7083333100
708WESTSUB3100 713359INC 713776M3100 713794LAB7 713794LAB9 713948INA
714843INNOVA 714966INNOVA 717217INN31 717782INNOVA31 717782INNOVA31A
717782INNOVA31B 718245UNITY 718250CATH1 718270INNOVA1 718283INNOVA3
718470INNOVA2 718780CATH2 724773C1 727725CATH2 7278253100 731422CV1 732294INOV
732776CATH6 760242CATH1 760242CATH2 760323DRINNOVA 765453INNOVA1 770991CL1
770991CL3 772LWCL1 773792CL3100 773NORWG3100 775982CATH2 781340IN2 785354S3100
8014793100 8019643100 803255CL1 803256PCL1 803329CL31 804285CATH1 8053703100
808547QCV2A 812238LIB1 812283IN31 812450CATH1 812450EP1 812482INNOVA
812858GWLAB1 812858GWLAB2 814676C1 815226INN2 815344CARDIAC3 815599FHN3100
8157413100 815756KCHSPEC 816478MC1 816861KCVAI1 816943STJIC1 816969LSCATH
816985NKCI 817433HSW3100 8184093100 8185023100 8189813100 843797TCL2 845365V19
847362CONCATH4 850469BCV1 850678IN3100 850747BR3100 850747GC3100 850862IN3100
856596IN3100 8613100 863687CL31 864255SFCL3 865481CCL2 865512CL3 865693CCL1
901516R3 903UT3100 904202CATH3 904276CTH1 907562CATH1 908522LAB1 909464IN3
909788INNOVA1 909825VAINNOVA 910343NHIN4 912486CATH1 913345MI1 916781INNOVA1
918333JPIN1 918333JPIN2 918494IN31A 919731WMINOV 919784REP1 9202623100
925779INNOVA408 928779INNOVA1 931459CV1 936266CL1 940626DCH3100 941798CLAB2
951788INNOVA2 951788INNOVA3 952993INNOVA5 954987CCL9 956389INN31 956698INN31
956994INN1 956994INN2 970350CL1 970945CL1 9734293100 973877LAB4 973971LAB3
BPINNOVA1 BPINNOVA2 BPINNOVA3R DR3100 ECXV1406B FHORLCL1 FHORLCL7 LVINOV4
MARTINSVILLE310 MCDCATH2 2575081 2601648 2610213 2625271 2638199 2652070 2656470
2661770 2680614 2681424 2682930 2686429 2698717 2699058 2713223 2713498 2713501
2713606 2716215 2724811 2725165 2727031 2728632 2729012 2729039 2730996 2731216
2731616 2732637 2739644 2741814 2742714 2745812 2745843 2745917 2749863 2750261
2751926 2752431 2753571 2753701 2754912 2754940 2754953 2754989 2755128
443481LCV 504447INNOVA2 580421V3100 609267IN3100 609597IN3100 610645LAB6
732776CATH2, and 909CH3100;
d) Lot numbers: 201541SP1 2035764100
204787INNOVA1 205759CL2 209467INNOVA308 216844INNOVA 219326IN41 2194654100
229228INNOV41C 229228INNOV41V 22925941V 22925941V2 229434INNOV 239436CATH1
239939INNOVA 248849SP1 250370INNOVA 251435I12 251435ICV5 252816INNOVA 252847PRS2
252847PRS3 269226IN1 269226IN2 269983IN41 281401T4100 3016094100 3018774100
3027444100 303320OR41 303399IR 303436ANGIO 303839CL1 304255INNOVA 304256INNOVA
304347INNOVA 304347INNOVA2 304424CCINOVA 305823IN4100 305835IN41 306766INNOVA
308534ANG 309343CSP1A 309655FSP1A 309655FSP3A 309672M4100 312792R4100 313343SP1
313876SP41 314569SJRM12 314966DPHSP 315448RM4 315448RM5 316651INNOVA41
316962INNOVA41 317338PV3 317887INNOVAPV 3184734100 319338VA4100 325670CATH
330489SPEC9 334286BSP 337981INNOVA 352333INVOR 352333VASC 352376SP 352401CATH
352401VASC 352596SPEC 360754INNOVA 386254HS1 386254HS2 386HPOS1 401274IN41
404466SF41A 404616INNOVA 404GHSIR1 404GHSIR2 407518SP2 407518SP3 407SPECIALS
4082594100 409212INOV41 4103374100 410337INNOVA2 4105434100 412623LAB1
412623LAB3 412647OR10 412784LAB1 412784LAB2 4134474100 4135344100 4137484100
414328INN4100 414649CL2 414649DVI 414961INN4100 4163694100 416756INNOVA
419251LAB1 419557ORLAB 419696LAB1 423493I4100 423495ENDO2 423495M4100E
423495MSPEC2 4438494100 478633INOV 478765ANG1 480512SP 5033704100 505848CATH2
505848V4100 508383IN4100 508650IN41 508856OR41 5094744100 509474SH41 509482HFI
509575YM4100 512528CPCL1 512901NI4100 5134754100 5135844100 5136864100
5138534100 514376INNOVA 514842AINNOVA 514934BANGIO 515263IL4100 516562INNOVA4
519663INNOVA2 519685INNOVA 530888ANG206 541282CV2 541686SPR1 5417684100
561548VAS2 561694IN1 561747IN4 561776IN41 561784INSP 5703214100 570321LAB2
5705224100 573632CRA 573761SMA 574294IN41 574535IN41 574647IN2 574647IN41
586573SP1 6012884100SP1 601376SP4100 6029234100 603650ANG1 604557INNOVA
605333RM10 606833INNOVA 6082634100 608263ACT 608263XMR 608324DAL 609652CATH3
610954INNOVA41 610988INNOVA4 613548INNOVA3 614293LIBERTY1 614293LIBERTY2
615284OR15 617525IN1 617636IN1 617726RF2Y6 618549CM4100 619229INNOVA1
620665INNOVA41 623848SP 626359INNOVA 630275G41 630275G41B 6309784100 650369SV5
650493ANGIOCT 6616324100 662244GTSP 678EJCIR1 7023604100 7028804100 704487CR41
706278INNOVA1 706291RINN 706291RINN2 706651SP1 706733SP1 706774USP3 706802FINN
708202VA41 7087564100 708783CL4100 708783SP4100 708WESTSUB4100 713375U4100
7137764100 715369INN4100 717763INNOVA41 717763OR4100 718206LIBERTY1 718250ANGIO
718518CVL1 718630LIBERTY 719560INN41 724656ANG 727398SPEC1 727725SPEC1
727791INNOVA 727819SPSC 740592INNOVA 757398INNOVA 757736INNOVA 757889INNOVA
760633IR1 770535N4100 770736SP1 773878SWGANGIO1 77573841 801268INNOVA 80140841
8014794100 80158241 80180741 802295VALCA 803256SP 803329CL41 804285CATH2
804320CATH2B 804594ANGIO 804594CATH 804764CATH3 810342A41 812238UN41
812279INNOVA1 812825INNOVA1 812858GWSP 813558INTV 813615CL10 813745INTV
813972INTV 815740SC4100 8159374100 816276SP1 816943SP1 817255NH4100
817433HSW4100 817465AR4100 817922BA4100 828298VASC 828696IN41 843577CL2
843674VAS1 843797TIR2 845368RM10 8458584100 847842GS4100 850494WSP1 850747IN4100
856365ANGIO 8593134100 8595724100 863687INV24 864255SF4100 864573LAB2 865373SP
865481SUR 865541CCL5 865693CCL3 901726SP2 903CSM4100 903GS4100 904202SP1
904276SP 904BSSP 908522SP1 913317SLS4100 915577SP1 918307SHIN4 918682IN41
918744JC4100 918744JR4100 9408984100 941483INNOVA41 952993INNOVA2 954MW4100
956632INN4100 970247INNOVA 972335LIB 972487ANGIO1 972566INNOVA3 985867INNOVA2
989466INNOVA COR359867 DR4100 ECXV1406E ECXVINNOVARST3 FHORL4100 FWANG3217
MCL4100 MIRAMAR41 PEMBROKE4100 RADNETXV1 RADNETXV2 RHD4100 SLIN4100 WCATHLAB41
2515139 0002520549A 2574392 2650620 2667650 2670537 2677299 2680596 2683976
2697900 2698692 2701519 2705539 2710199 2712110 2712111 2713221 2718141 2722283
2729637 2730844 2733412 2733723 2740431 2741400 2741459 2741764 2742712 2742719
2743706 2744276 2744293 2744745 2745129 2745685 2745844 2746655 2750142 2750583
2753604 2754920 2756873 2757398 256429SV1 317621PV 318681INNOVA1 6012884100SUR
609757IN4100 731541XA1 904202SP2 906485ANGIO ECXVINNOVARST1 ECXVINNOVARST2, and
ECXVINNOVARST4
RECALLING FIRM/MANUFACTURER
Recalling
Firm: GE Healthcare, Waukesha, WI,
Manufacturer:
GE Medical Systems, SCS, Buc Cedex, France.
REASON The charger and/or battery of the PDB may
fail earlier than expected with no advance warning and thus cause the system to
shut down.
VOLUME OF PRODUCT IN COMMERCE 1,573
units
DISTRIBUTION Nationwide and
Guam
PRODUCT
a)
500 mL InfoV.A.C. Canisters (with Gel); 1) Part #M8275063/5 (5 canister pack)
and 2) Part #M8275063/10 (10 canister pack); products are single use and labeled
as STERILE,
b) 500 mL InfoV.A.C. Canister (without
Gel); 1) Part #M8275071/5 (5 canister pack) and 2) Part #M8275071/10 (10
canister pack); products are single use and labeled as STERILE,
CODE
a) 1) 20064392, 20069119, 20069125,
20069126, 20069279, 20069279.18308F, 20075082, and 20079173; 2) 20046268,
20046268.18908A, 20046270, 20063933, 20064393, 20064394, 20064395, 20064753,
20064753.14408B, 20067300, 20067300.14408B, 20067301, 20067302, 20067303,
20067304, 20067305, 20069120, 20069121, 20069273, 20069273.14408B; 20069274,
20069275, 20069275.18908A, 20069277, 20069277.18908A, 20069278, 20069278.18908A,
20069280, 20075084, 20075085, 20075086, 20075262, 20075263, 20075264, 20075265,
20075266, 20075268, 20075269, 20079174, 20079175, 20079176, 20079177, 20079178,
20079179, 20079180, 20079181, 20079182, 20079183, 20079184, 20079185, 20079186,
20079187, 20079188, 20089680, 20089681, 20089682, 20089712, 20089713, 20089749,
20089750, 20093372, 20093374, and 20094200;
b) 1) 20063928; 2) 20062500, 20063927, 20063927.15108D, 20063930,
20063930.15108D, 20067296, 20067297, 20067298, 20069122, 20069123,
20069123.15108D, 20069124, 20069124.15108D, 20069276, 20071227, 20073941,
20075083, 20075267, 20079189, 20079190, 20079191, 20089714, and
20094198
RECALLING FIRM/MANUFACTURER
Recalling Firm: KCI
USA, Inc., San Antonio, TX,
Manufacturer:
Avail State College, Bellefonte, PA.
REASON The port on the 500mL
InfoV.A.C. Canister
that connects to the suction pump tubing was found to be partially or fully
occluded with plastic.
VOLUME OF PRODUCT IN
COMMERCE 229,400
canisters
DISTRIBUTION Nationwide, Austria, Belgium,
Denmark, France, Germany, Netherlands, Sweden, and the UK
PRODUCT MONARCH®
II IOL Delivery System, Cartridge Model B, part #8065977758, packaged in
pouches, 10 pouches/carton, and labeled in part ***for AcrySof® IOLs*** The
product is used for implanting intraocular lenses (IOLs) into the eye following
cataract removal. Each cartridge is imprinted with the model type on the wing of
the Monarch II cartridge which can be visually verified prior to use,
CODE
Lot 174249 Exp 07/2010 Lot 174250 Exp
07/2010 and Lot 174244 Exp 07/2010
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Alcon Laboratories, Inc., Fort
Worth, TX,
Manufacturer: Alcon Manufacturing
Ltd., Huntington, WV.
REASON Delivery cartridge for implanting
intraocular lenses is mislabeled and may result in complicated insertion and
damage to the lens.
VOLUME OF PRODUCT IN COMMERCE 7,962
units
DISTRIBUTION Nationwide, Brazil, Canada, Chile,
Hong Kong, Singapore and India
PRODUCT
a)
SERVO-i Ventilator System. The product is intended for treatment and monitoring
of patients in the range of neonates, infants and adults with respiratory
failure or respiratory insufficiency. Article number 64 87 800,
b) SERVO-s Ventilator System. The product is intended
for treatment and monitoring of patients in the range of neonates, infants and
adults with respiratory failure or respiratory insufficiency. Article Number:
66-40-440,
CODE
a) Serial numbers:
34034, 34035, 34050, 34052, 34053, 34054, 34058, 34060 through 34083, 34085,
34086, 34087, 34088, 34090, 34096, 34099 through 34287, 34293, 34294, 34295,
34296, 34298, 34299, 34302, 34303, 34305, 34309, 34313, 34315, 34319, 34230,
34323, 34324, 34326, 34329, 34330, 34343, 34345, 34348, 34350, 34357, 34360,
34376, 34384, 34390, 34427, 34490, and 34530;
b) Serial numbers: 7591, 7604, 7605, 7606, 7607, 7608, 7609, 7610, 7613
through 7666, 7676, 7677, 7678, 7879, 7680, 7681, 7682, 7686 through 7703, 7709
through 7724, 7737, 7740, 7745, 7749, 7750, 7758, 7759, 7760, 7763, 7764, 7770,
7771, 7772, 7775, 7776, 7777, 7778, 7779, 7800 through 7825
RECALLING
FIRM/MANUFACTURER
Recalling Firm: MAQUET Inc., Bridgewater, NJ,
Manufacturer: Maquet Critical Care AB,
Solna,
Sweden. REASON Maquet
became aware of potentially defective crimpings at the point connector attached
to the cable in SERVO-i and SERVO-s ventilators.
VOLUME OF PRODUCT IN
COMMERCE 404 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT
Quicklock Tracker, Size 2; ref: 111.100. Device is a surgical
instrument,
CODE Lot numbers:
PC040050, PC030403, PC040292, PC040293, PC050034, PC050129 and
PC050034-1
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Zimmer, Inc., Warsaw, IN,
Manufacturer: Orthosoft, Inc., Montreal, Quebec, Canada.
REASON
The three-point array may
break during use, resulting in surgical delay and an increased risk of
infection.
VOLUME OF PRODUCT IN COMMERCE 239
units
DISTRIBUTION Nationwide
PRODUCT
NicoletOne 5.30.2 Software when used with CSeries amplifiers in
Fixed Room LTM Configurations with patient room kits. The product is used for
extended monitoring of EEG in a hospital setting. The system provides connection
between the patient room EEG acquisition system and central control room,
CODE
Lot numbers: PB070799 PB060399
PB060413 PB080901 PB070523 PBO80944 PB060414 PB060333 PB070817 PB070677 PB070669
PB PB060478 PB060207 PB080873 PB060234 PB060346 PB070605 PB060370 PB060461
OA040136R PB070844 PB070684 PB060421 PB060384 PB080890 PB060306 PB070837
PB070649 PB070638 OA050455 PB060192 PB070788 PB070746 PB060500 PB060227 PB070533
PB080999 PB060291 PB050140 PB070853 PB070673 PB070733 PB080980 PB070852 PB060511
PB060510 PB060383 PB060342 PB060502 PB080948 PB060465 PB060362 PB080995 OA050421
PB070749 PB070571 PB070718 PB080878 PB070861 PB060338 PB060353 PB070606 PB060386
PB050153 PB080953 OJ060318 OA040179R OJ060389 OJ060393 OJ060388 OJ060378
OJ060437 OJ060434 OJ060435 OJ060432 OJ060433 OJ070476 OJ070477 OJ070464 OJ070462
OJ070465 OJ070466 OJ070463 OJ070461 OJ070455 OJ070460 OJ070459 OJ070458 OJ070457
OJ070456 OJ070478 OJ070505 OJ070510 OJ070535 OJ070534 OJ070532 OJ070533 OJ070531
OJ070530 OJ070446 PB070591 PB070590 PB070754 PB070753 PB070765 PB070767 PB070766
PB070770 PB070771 PB070772 PB060191 PB070769 PB080924 OJ070498 OJ070489 OJ070527
OJ080542 OJ080555 OJ060314 OJ060341 OJ070479 OJ080548 OJ080554 OJ080553 OJ080560
OJ080581 OJ080559 OJ060321 OJ060320 OJ060323 OJ060322 OJ060324 OJ060325 OJ060327
OJ060328 OJ060326 PB060393 PB060469 PB070579 PB070582 PB070583 PB070580 PB070581
PB070578 PB070593 PB070665 and PB070820
RECALLING
FIRM/MANUFACTURER Cardinal Health NeuroCare Division, Madison, WI,.
REASON
NicoletOne 5.30.2 Software when used with
CSeries amplifiers in Fixed Room LTM Configurations with patient room kits. The
3rd party room relay connected to the A2 wall plate does not always activate if
the patient event button connected to the CSeries Amplifier is pressed twice
within one second.
VOLUME OF PRODUCT IN COMMERCE 274
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Cholestech GDX A1C Test Cartridge. The Cholestech GDX A1C Test is
an in-vitro diagnostic test that measures hemoglobin A1c (HbA1c). Catalog
#12-658,
CODE Lot
#066T28
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Cholestech Corp., Hayward, CA,
Manufacturer:
Provalis Diagnostics Limited, Deeside, Flintshire CH5 2NU, UK.
REASON
Stability data
indicated that the product would not meet performance claims through the end of
its shelf life.
VOLUME OF PRODUCT IN COMMERCE 9,324
cartridges
DISTRIBUTION Nationwide, India, Slovenia,
Germany, Tunisia, Taiwan, Canada, Philippines, South Africa and Mexico
PRODUCT
Quick
Connect component p/n 201048. The component is contained in: a) QPC1713 and b)
QPC1724 Quick Connects. The QPC1724 is used to attach Pentax
70/70K/72/72K/80K/81K/90i/90K Series GI Endoscopes with Water Jet to the C1160
Universal Flexible Processing Tray in the SYSTEM 1 Sterile Processing System.
The QPC1713 is used to attach Pentax 70/70K/80K/85/85K/90K SERIES GI ENDOSCOPES
without Water Jet to the C1160 Universal Flexible Processing Tray in the SYSTEM
1 Sterile Processing System,
CODE
a)
Serial #: 3870300, 3870367, 3870326, 3870342, 3923281, 3954195, 4008389,
4045720, 4091419, 4153292, 4201828, 4274429, 4297354, 4247052, C601846, C601879,
4569117, 4710430, 4770715, 4862314, 4899068, 4942173, 5005517, 5098421, and
5261433;
b) Serial # 3500782, 3531266, 3614856, 3644010, 3681319, 3753928,
3753944, 3754231, 3864709, 3865110, 3879319, 3935418, 3962214, 3967825, 4054979,
4123873, 4186201, C601848, 4274445, 4363339, 4247078, 4479853, 4588679, 4632667,
4684007, 4738753, 4802294, 4810867, 4869749, 4899084, 4942199, 4952487, 4987020,
5026513, 5063789, 5098447, 5159215, 5211669, 5256367, and
5257266
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Steris Corp., Mentor, OH,
Manufacturer:
Steris Corp., Hopkins Facility, Mentor, OH.
REASON During ongoing product development
testing, it was discovered that, when the two inflow barbs on adapter 201048 # 4
are in a position to face one direction, the top Barlock may interfere with the
top surface of bottom barb of the adapter. The interference may cause the
plunger on the suction side to lift slightly which may affect flow of sterilant
into the suction lumen.
VOLUME OF PRODUCT IN COMMERCE a)
108 units; b) 557 units
DISTRIBUTION Nationwide, Canada,
Australia, Italy, Spain, and Thailand
PRODUCT Drystar AXYS, Hardcopy Printer A free standing device used to print diagnostic
conventional and mammography images on transparent film for viewing on a
standard view box. It may be used in any situation in which a hard copy of an
image generated by a medical imaging device is required or desirable. ID number
EYZ4E,
CODE
Serial numbers: 1024 to
1189; but excluding 1053, 1057, 1089, 1096, 1097, 1098, 1101, 1103, 1161, 1166,
1173, 1176, 1177, 1178, 1180, 1181, 1185, 1186, 1187 and
1188
RECALLING FIRM/MANUFACTURER
Recalling Firm: AGFA
Corp., Greenville, SC,
Manufacturer:
Agfa-Gevart NV, Mortsel, Belgium.
REASON The "Film Calibration" setting on the printers
was set to the default "OFF" position instead of "ON".
VOLUME OF
PRODUCT IN COMMERCE 33
units
DISTRIBUTION Nationwide and
Canada
PRODUCT NobelReplace Tapered Groovy RP 4.3x10mm. These products are
root-form endosseous implants intended to be surgically placed in the bone of
the upper or lower jaw arches to support for prosthetic devices. Ref 32216,
CODE
Lot number:
403504
RECALLING FIRM/MANUFACTURER Nobel Biocare USA, LLC, Yorba Linda, CA,
REASON
The
NobelReplace Tapered Groovy RP 4.3x10mm, REF 32216 Lot#403504 has an incorrect
cap label. The affected lot has a cap label identifying the implant as "4.3x8".
Since this cap label may be the only means used for identifying the implant
prior to surgery, it is possible that a user would try to use the 10mm implant
as an 8mm implant.
VOLUME OF PRODUCT IN COMMERCE 197
units
DISTRIBUTION Nationwide
PRODUCT Ocular Conformer, Sterile. The device is intended to be used as a
post eye surgery device to prevent closure or adhesion during the healing
process. Catalog number: 9574, Catalog number 9548, Catalog number 9549, Catalog
number 9779, and Catalog number 9780, CODE Lot number 001061103C, Lot number
002010204-C, Lot number 003061103C, Lot number 002050804C, Lot number
006101204-C
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Porex Surgical, Inc., Newnan, GA,
Manufacturer: R.O. Gulden &
Co., Inc., Elkins Park, PA.
REASON The Ocular Conformers were distributed
with an expired expiration date.
VOLUME OF PRODUCT IN
COMMERCE 9 units
DISTRIBUTION PA, Canada and
Germany
PRODUCT Histochemical
PAS (Periodic Acid Schiff) Reaction Set' Class I, IVD; Set of 4 bottles including Schiff Reagent 225
mL, Light Green SF Yellowish
Stain 225 mL, Sodium Carbonate Solution 225 mL and Periodic Acid Solution 225 mL'; Each kit provides reagents sufficient for a maximum of 100 tests. Item
number 64945/93,
CODE Lot # 8055,
Exp. August 31, 2009
RECALLING FIRM/MANUFACTURER EMD
Chemicals, Inc., Gibbstown, NJ,
REASON Two complaints that
kit was not performing properly with positive controls.
VOLUME OF
PRODUCT IN COMMERCE 29 kits (a kit of 4
bottles)
DISTRIBUTION Nationwide
PRODUCT Corflo Anti-I.V. NG Tube for Pediatric and Neonatal Use; a sterile
clear polyurethane with orange radiopaque stripe Enteral Feeding Tube without
Stylet, 5 Fr, 22" long, non-weighted, DEHP and latex free; individually
packaged, 10 tubes per carton; Product is intended for use in those patients who
require intermittent or continuous tube feedings via the nasogastric or
nasoenteric route. Catalog/reorder number 20-1225AIV,
CODE Lot number: 32601
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Cardinal Health, Mc Gaw
Park, IL,
Manufacturer: VIASYS Medsystems, Wheeling, IL.
REASON The male Luer adapter may be the wrong
component therefore the feeding set would not be able to be connected to the
tube nor would the cap fit securely.
VOLUME OF PRODUCT IN
COMMERCE 807 tubes
DISTRIBUTION CA, IL, KY
and MO
PRODUCT Stryker Biotech OP- 1 Implant is indicated for use as an
alternative to autograft in recalcitrant long bone nonunions where use of
autograft is unfeasible and alternative treatments have failed. Catalog Number:
100-25,
CODE Lots Numbers:
FC0803004, FC0803005, FC0804002, FC0804007, FCO804010, FC0805002, FC0805003,
FC0805004
RECALLING FIRM/MANUFACTURER Stryker Biotech,
Hopkinton, MA
REASON Product package
insert misprint-text offset.
VOLUME OF PRODUCT IN
COMMERCE 803
units
DISTRIBUTION Nationwide
PRODUCT
a) Medtronic iCon Patient Programmer, model 3037. The Patient
programmer is a hand held, battery operated, microcontroller based device for
use by patients to control and monitor external and implantable devices. The
minimum amount of control involves the ability to turn therapy ON or OFF;
maximal control allows the patient to select from different therapies and adjust
the parameters with in the set therapy limits,
b)
Medtronic Patient programmer, model 37742. The Patient programmer is a hand
held, battery operated, microcontroller based device for use by patients to
control and monitor external and implantable devices. The minimum amount of
control involves the ability to tun therapy ON or OFF; maximal control allows
the patient to select from different therapies and adjust the parameters with in
the set therapy limits,
CODE
a) and
b) Serial numbers: NJD058707N, NJD062024N, NJD063259N, and
NJD063324N
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Medtronic Neuromodulation, Minneapolis, MN,
Manufacturer: Benchmark Electronics Inc., Winona, MN.
REASON
Medtronic is
retrieving four (4) patient programmers that were not properly loaded with
application software. The application software is needed for a patient
programmer to synchronize and bond with a neurostimulation device. Without this
functionality a patient programmer is not useable and can not communicate with a
neurostimulation device.
VOLUME OF PRODUCT IN COMMERCE 4
units
DISTRIBUTION GA, MO, NC,
TX
PRODUCT
Integra Dermal Regeneration Template; 8 x 10 in. (20 cm x 25 cm),
Sterile; Catalog number 38101,
CODE Lot Number:
105BA0121823
RECALLING FIRM/MANUFACTURER Integra
LifeSciences Corp., Plainsboro, NJ
REASON Product labeled with an
expiration date on May 2010, while the actual expiration date should be April
2010.
VOLUME OF PRODUCT IN COMMERCE 10
units
DISTRIBUTION TN, CA, NY, IN and AL
Thoratec Corporation Issues Medical Device Correction of HeartMate II® Left Ventricular Assist System
Thoratec Corporation is initiating a worldwide medical device correction of all serial numbers of the HeartMate II Left Ventricular Assist Systems (HM II LVAS) having Catalogue No. 1355 or 102139, which have been distributed since the beginning of clinical studies in November 2003. Over time, wear and fatigue of the percutaneous lead connecting the HeartMate II LVAS blood pump with the System Controller may result in damage that could interrupt pump function, require reoperation to replace the pump and potentially result in serious injury or death. The estimated probability of the need for pump replacement due to percutaneous lead damage is 1.3% at 12 months, 6.5% at 24 months and 11.4% at 36 months.
Patients who are currently being supported by a HeartMate II LVAS should contact their doctors, who can assess the wear and fatigue of the percutaneous lead as well as provide proper instruction on management and care of the lead.
The affected systems were distributed to 153 hospitals and distributors throughout the United States, Europe, Canada and other countries. The HM II LVAS can be identified by the catalogue number located on the label of the package.
Clinicians and patients with questions may contact the company at 1-800-528-2577, or if calling from outside the USA, 1-925-847-8600 (7 days a week, 8-5 Pacific Time).