AUGUST 2005
WEEK ENDING AUGUST 6
PRODUCT
a) DISCOVERY pacemaker
(model nos. 1174, 1175, 1273, 1274 and 1275).
b)
MERIDIAN pacemaker (model nos. 476, 976, 1176 and 1276)
c) PULSAR and PULSAR MAX (model nos. 470, 870, 970,
972, 1170,
1171, 1172, 1270 and 1272) pacemaker,
d) PULSAR MAX
II (model nos. 1180, 1181 and 1280) pacemaker
e)
DISCOVERY II (model nos. 481, 981 1184, 1186, 1187, 1283, 1284, 1285 and
1286) pacemaker,
f) VIRTUS PLUS II (model nos. 1380
and 1480) pacemaker,
g) INTELES II (model nos. 1349,
1384, 1385, 1483, 1484, 1485 and 1499) pacemaker
h)
CONTAK TR (model no. 1241) pacemaker,
CODE
a) Model 1174: Serial numbers 109017 thru 115660,
Model 1175: Serial numbers 200731 thru 202199,
Model 1273: Serial
numbers 315516 thru 324528, Model 1274: Serial numbers 296080 thru
496546,
Model 1275: Serial numbers 500705 thru 501661;
b) Model 476:
Serial numbers 103316 thru 106064, Model 976: Serial numbers 202612 thru
205357,
Model 1176: Serial numbers 303330 thru 306689, and Model 1276:
Serial numbers 404640 thru 409060;
c) Model 470: Serial numbers 101150 thru
101894, Model 870: Serial numbers 200201 thru 201205,
Model 970: Serial
numbers 300808 thru 301676, Model 972: Serial numbers 452959 thru
454562,
Model 1170: Serial numbers 100610 thru 103665, Model 1171: Serial
numbers 300733 thru 302575,
Model 1172: Serial numbers 594273 thru
594437, Model 1270: Serial numbers 595951 thru 608303,
Model 1272: Serial
numbers 600250 thru 600749;
d) Model 1180: Serial numbers 100001 thru
100055, Model 1181: Serial numbers 300001 thru 300050,
Model 1280: Serial
numbers 500003 thru 500525;
e) Model 481: Serial numbers 100000 thru
100115, Model 981: Serial numbers 200002 thru 200041,
Model 1184: Serial
numbers 300012 thru 300061, Model 1186: Serial numbers 500000 thru
500054,
Model 1187: Serial numbers 450000 thru 450010, Model 1283: Serial
numbers 600001 thru 600073,
Model 1284: Serial numbers 700000 thru
700079, Model 1286: Serial numbers 900000 thru 900059;
f) Model 1380:
Serial numbers 100000 thru 100044, Model 1480: Serial numbers 500005 thru
500072;
g) Model 1349: Serial numbers 100003 thru 100076, Model 1384:
Serial numbers 300000 thru 300073,
Model 1385: Serial numbers 400005 thru
400019, Model 1483: Serial numbers 600005 thru 600082,
Model 1484: Serial
numbers 700005 thru 700064, Model 1485: Serial numbers 800005 thru 800053,
Model 1499: Serial numbers 200001 thru 200073; h) Serial numbers 200128
thru 200479
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Guidant Corp-Cpi Division, Saint Paul, MN
Manufacturer: Guidant-Ireland,
Clomel, Ireland.
REASON A hermetic sealing component utilized in
the device may experience a gradual degradation, resulting in a higher than
normal moisture content within the pacemeaker case late in the device's service
life.
VOLUME OF PRODUCT IN
COMMERCE 34,026
DISTRIBUTION Nationwide and
Internationally
PRODUCT Nichols Advantage ACTH
Test System, catalog number 62-7004
CODE Lot
numbers: 62-500040 and 62-404296
RECALLING
FIRM/MANUFACTURER Nichols Institute Diagnostics, San Clemente, CA
REASON
Performance does not meet claims in the Directional
Insert concerning correlation with the IRMA ACTH assay.
VOLUME OF PRODUCT
IN COMMERCE 1,599
DISTRIBUTION Nationwide and
Internationally
PRODUCT
Ohmeda
Medicalís Giraffe’ OmniBeds and Giraffe Incubators
CODE Serial Numbers: HDHE50001 to
HDHE50164; HDHF50001 to HDHF50357; HDHF52001 to HDHF52212; HDHF53001 to
HDHF53156; HDHF54001 to HDHF54168; HDHG54001 to HDHG54320; HDGD50200 to
HDGD50389; HDGE50001 to HDGE50591; HDGF50001 to HDGF50046; HDGF52001 to
HDGF52036; HDGF53001 to HDGF53102; HDGF54001 to HDGF54190; HDGG54001 to
HDGG54367
RECALLING FIRM/MANUFACTURER Ohmeda Medical, A division of
Datex-Ohmeda, Inc., Laurel, MD
REASON Neonatal incubators and beds may
unintentionally move from a safe position following an interruption in the power
supply.
VOLUME OF PRODUCT IN COMMERCE 788
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) PICC Catheter - 4.5
Fr Dual Lumen, Catalog #PIC402CK Material Number M001PIC402CK0
b) PICC Catheter - 4.5 Fr Dual Lumen Catalog #PIC402CKIR,
Material Number M001PIC402CKIRO, c) PASV PICC
Catheter - 4.5 Fr Dual Lumen, Catalog #PIC402CKMS, Material Number
M001PIC402CKMSO,
d) PICC Custom Kit GENESIS MEDICAL
CENTER, 4.5F Dual Lumen, Catalog #60M120522.
UPN M00160M1205220
CODE
a) 917971, 921390, 926395, 926672, 928269;
b)
919488, 924206;
c) 925620;
d) 898659, 899145;
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corporation,
Natick, MA
Manufacturer: Boston
Scientific Corp, Glens Falls, NY.
REASON Lumens may have incorrect lumen size marked on
them. The smaller capacity proximal fitting is on the larger handling volume
lumen and the larger capacity proximal fitting on the smaller handling lumen.
This may result in a slower rate of infusion.
VOLUME OF PRODUCT IN
COMMERCE 242 units
DISTRIBUTION Nationwide
PRODUCT
a) BD Syringes - #309585
-- Piston Syringe, Syringe 3ML LL Syringe. ;
b) #
309603 -- Syringe 5Ml LL syringe,
c) # 309604 --
Syringe 10 mL LL
d) #309661 -- Syringe only ll 20 mL
e) #309644 -- 10 ml syringe with 20 G1' Needle,
f) #309604 -- 10 mL syringe
CODE
a) Affected Lot 309585 Syringe 3ML LL
Syringe
only Lot 5064003;
b) 309603 Syringe 5ML LL Syringe only 5067050, 309603
Syringe 5ML LL Syringe only 5062940;
c) 309604 Syringe 10 ML LL
5063484, 309604 Syringe 10 ML LL 5063495, 309604 Syringe 10 ML LL
5055564, 309604 Syringe 10 ML LL 5055567, 309604 Syringe 10 ML LL
5063493;
d) 309661 Syringe only LL 20 ML 5061527, 309661 Syringe only LL
20 ML 5047172;
e) 309644 10 mL Syringe with 20 Glî needle 5033890;
f)
309604 10 mL Syringe 5074833
RECALLING FIRM
Recalling Firm: Becton
Dickinson & Company, Franklin Lakes, NJ,
Manufacturer: Becton Dickinson Medical Systems, Canaan, CT.
REASON
The firm believes that some of
the syringes in the affected lots may not have received the intended
sterilization dose.
VOLUME OF PRODUCT IN COMMERCE 3,857,760
units
DISTRIBUTION Nationwide
PRODUCT Mammomat Novation
Digital Mammography System. Model number 646900
CODE Serial numbers 1001, 1009, 1019, 1020, 1021, 1024,
1035, 1038, 1039, 1044, 1045, 1046, 1047, 1051, 1052, 1054, 1055, 1058, 1060,
1063, 1064, 1105, 1107, 1108, 1114, 1208, 1209, 1210, 1211, 1212, 1214, 1216,
1217, 1220, 1224, 1227, 1228, 1229, and 1234.
RECALLING
FIRM/MANUFACTURER
Recalling firm: Siemens Medical Solutions USA, Inc.,
Malvern, PA
Manufacturer: Siemens
Medical Solutions, Erlangen, Germany.
REASON Potential issue (image acquisition may become
interrupted) when using multiple network nodes.
VOLUME OF PRODUCT IN
COMMERCE 33 units
DISTRIBUTION Nationwide
PRODUCT Baxter Interlink System
Huber Needle Extension Set; a sterile 10î fluid pathway with an Interlink Y
--Injection Site and ¾î x 22 gauge needle,
CODE Lot number: FC04058
RECALLING
FIRM
Recalling Firm: Baxter Healthcare, Corp., Round Lake, IL
Manufacturer:
Command Medical Products,
Ormond Beach, FL.
REASON Some of
the product code 2N3709 extension sets with Y-injections sites were placed in
packages labeled as product code 2N3703 extension sets which do not have
Y-injection sites.
VOLUME OF PRODUCT IN COMMERCE 4,850
units
DISTRIBUTION AK, FL, TX, NC, WI and Japan
WEEK ENDING AUGUST 20
PRODUCT Polystan Coronary
Cannula Balloon Tip( Cardiopulmonary bypass vascular catheter)
CODE Lot numbers: 162119; 162572; 163299; 164050; 165934;
167444; 167446; 171658; 176841; 178282; 179626; 180352; 180822; 184419; 185618;
186149; 187100; 188865
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Maquet Inc, Bridgewater, NJ
Manufacturer: Jostra Ag,
Hirrlingen, Germany.
REASON Upon acquisition of Jostra AG,
manufacturer of Polystan Coronary Cannula Balloon Tip Catheters, Maquet was
unable to confirm the catheterís FDA approval status.
VOLUME OF PRODUCT IN
COMMERCE 890 units
DISTRIBUTION Nationwide
PRODUCT Locking Tear-Away Sheath
Introducer Product Line. ACCUGUIDE SINGLE LUMEN 4FR PICC P460K 5/; P560K PICC
5FR W/INTRO KIT; MTI451845 4.5FR MINI T/A; MTI551845 5.5FR MINI TA; MTI651845
6.5FR MINI T/A; P460OTW SNGL LUM PICC W/MTI; P4552K DBL LUM PICC INTRO KIT;
P5552K DBL LUM PICC INTRO KIT; P4552KOTW DBL LUM OTW PICC INTRO KIT LF; LOCKING
T/A INTRODUCERS 11FR; INTRADYN TEAR-AWAY INTRODUCER 4F; INTRADYN TEAR-AWAY
INTRODUCER 5F; INTRADYN TEAR-AWAY INTRODUCER 6F; INTRADYN TEAR-AWAY INTRODUCER
7F; INTRADYN TEAR-AWAY INTRODUCER 8F; INTRADYN TEAR-AWAY INTRODUCER 9F; INTRADYN
TEAR-AWAY INTRODUCER 10F; INTRADYN TEAR-AWAY INTRODUCER 11F; INTRADYN TEAR-AWAY
INTRODUCER 12F; INTRADYN TEAR-AWAY INTRODUCER 15F; INTRADYN TEAR-AWAY INTRODUCER
16F; 23HI120 12F X 23CM HEMO INTRO; 23HI130 13F X 23CM HEMO INTRO; 30STA8 8FR
X30CM T/A INTRO -NJ*; 30STA9 9FR X 30CM SHEATH -NJ*; 30STA10 10FR X 30CM T/A
INTRO -NJ*; 30STA12 12FR X 30CM T/A INTRO -NJ*; 30STA16 16FR X 30CM SHEATH;
BOSTON SCI 16F X 9.54 STEP DIL/SHEATH; 45STA9 45CM T/A INTRODUCER -NJ*; LUTHER
6F - T/A ASSM CLIP; 10HI14038 14F X 11CM HEMO W/WI; BOSTON SCI 12FX 21.35 DIL/SHEATH; 10HI12038 12F X 11CM HEMO W/WI; 10HI13038 13F X 11CM HEMO W/WI;
BOSTON SCI 9F X 9.54 STEP DIL/SH; BOSTON SCI 9F X 15.44 STEP DIL/SH; BOSTON SCI
9F X 21.35 STEP DIL/SH; BOSTON SCI 11F X 9.54 STEP DIL/SH; BOSTON SCI 11F X
15.44 STEP DIL/SH; BOSTON SCI 12F X 9.54 DIL/SHEATH; BOSTON SCI 12F X 15.44 DIL/SHEATH; BOSTON SCI 14F X 9.54
DIL/SHEATH; BOSTON SCI 14F X 15.44 DIL/SHEATH;
BOSTON SCI 16F X15.44 DIL/SHEATH; 30STA15 15FR LONG TA INTRODUCR; 30STA11 11FR
LONG TA INTRODUCR -NJ*; CARDIAC PACEMAKER T/A SHEATH; 14FR TA
DILATOR/SHEATH-BULK; 12FR INTRODUCER TEAR AWAY BNS; 12FR TA DIL/SHEATH LC; 8FR
TA SHEATH; 10FR TA SHEATH; 16FR TA SHEATH; 8/10FR LOCK T/A INTRO STEPPED; 6FR
T/A DILATOR/SHEATH; 6FR LOCKING T/A INTRO ASSY; 14FR X 143MM LOCKING T/A
INTRODUCERS; PTFE 4.5 FR BARD ACCESS INTRODUCERS; PTFE 6.0 FR BARD ACCESS
INTRODUCERS; 7F LOCKING INTRO SYSTEM; 8 (O/S) FR. LOCKING TEARAWAY INTRODUCER; 9
FR (0/S) LOCKING INTRO SYSTEM; 12F LOCKING INTRO SYSTEM; 14FR LOCKING T/A
INTRODUCER; 10FR X 18 CM LOCKING T/A INTRODUCER; 14FR X 12MM LOCKING T/A
INTRODUCER; 10.5FR X 18CM LOCKING T/A INTRODUCER; 10FR X 23CM LOCKING T/A
INTRODUCER; 10FR LOCKING TEAR-AWAY INTRODUCERS; INTRADYN TEAR-AWAY INTRODUCER
10.5F; 30STA14 14FR X 30CM T/A INTRO -NJ*; BOSTON SCIENTIFIC 15FR LOCKING
TEARAWAY; CELSA 5FR LOCKING T/A INTRODUCER; CORDIS 4" BLUNT TIP T/A SHEATH;
MEDTRONIC PS MED INTRO ASM 14F -NJ*; MEDTRONIC PS MED INTRO ASM 15F.
CODE
Catalog #, Lot Numbers: 333603--Lot #s
0060529076,0060542787, 0060551433, 0060552115, 0060553837, 0060562411,
0060702019, 0060702049. 333604--0060553838, 0060708443, 0060713806.
333606--0060472888, 0060516047, 0060583876, 0060710305, 0060710306, 0060751880.
333608--0060569225, 0060703806, 0060729030, 3360734585. 333609--0060703808.
333610--0060738852. 333612--0060542791, 0060549251, 0060553963, 0060702064,
0060708037. 333613--0060549252, 0060553909, 0060702069, 0060702071, 0060702074.
333614--0060521374, 0060551766, 0060702082. 610064--0060709374.
610100--0060702177, 0060761533. 610101--0060702179. 610102--0060710159.
610103--0060713850. 610104--0060734898, 0060741005. 610105--0060722688,
0060740847. 610106--0060702186. 610108--0060702192. 610109--0060713856.
610112--0060719604. 610113--0060723081. 610145--0060570243. 610146--0060560608.
610150--0060551068. 610151--0060707659, 0060710792. 610152--0060710794.
610153--0060551073, 0060568835. 610155--0060708367, 0060708367, 0060742089.
610177--0060558435, 0060707652, 0060709662, 0060746191, 0060766191.
610264--0060707534. 610407--0060732173. 610559--0060523821, 0060555811,
0060572434, 0060709663, 0060726953, 0060733425. 610570--0060726955.
610652--0060707368, 0060737064. 610654--006545559, 0060552179, 0060744541.
610811--0060473107, 0060473108, 0060560316, 0060738144. 610812--0060726992.
610813--0060757144. 610814--0060572400, 0060732297. 610815--0060538361,
0060542288, 0060757084. 610816--0060520549, 0060523748, 0060538364, 0060572403,
0060710820, 0060722731. 610817--0060544240, 0060545503, 0060569903, 0060571978.
610818--0060528048, 0060561924, 0060709739, 0060726994. 610819--0060545504,
0060709740, 0060727002. 610820--0060707651. 610830--0060712212, 0060742386.
610843--0060709735. 610894--0060544824, 0060545508, 0060557624, 0060707071,
0060715230, 0060728009, 0060752044, 0060752045. 610916--0060710874, 0060710875.
610923--0060497968, 0060545511, 0060754189, 0060516182, 0060545512, 0060569910.
610974--0060719256. 610976--0060517487, 0060551012, 0060564301, 0060571977,
0060709065, 0060719972. 610982--0060725523. 611109--0060523767, 0060545524,
0060551019, 0060555703, 0060706362, 0060707365, 0060709725, 0060716210.
611172--0060706038. 611840--0060519177, 0060540542, 0060545484, 0060552193,
0060564379, 0060707285, 0060711192, 0060722451. 612001--0060528366, 0060541715,
0060709669. 614006--0060545527, 0060545529, 0060548273, 0060555801, 0060564933, 0060569911,
0060572409, 0060706138, 0060706158, 0060706169, 0060706174, 0060709679,
0060749179. 614007--0060473083, 0060494998, 0060503536, 0060507452, 0060517491,
0060545530, 0060545531, 0060551054, 0060564304, 0060564934, 0060566303,
0060566304, 0060566305, 0060712277, 0060720315, 0060724332, 0060726782,
0060750181. 614008--0060545533, 0060548274, 0060554892, 0060555802, 0060564936,
0060568832, 0060569912, 0060572414, 0060576479, 0060576483, 0060576484,
0060712278, 0060712279, 0060712280, 0060737734. 614012--0060747064.
614037--0060547187, 0060735870. 614100--0060709646, 0060709647, 0060715276,
0060720258, 0060521185, 0060536288, 0060538205, 0060551057, 0060560474,
0060572417. 614101--0060709664, 0060709667, 0060715113. 614102--0060562423,
0060710927. 614104--0060580188, 0060707545. 614400--0060588319, 0060707536,
0060707537, 0060707538, 0060712281, 0060722450, 00607727033, 0060749069.
610107A--0060702191, 0060746124. 610154A--0060709726. 7B2807--0060709702,
0060709703, 0060709704, 0060709705, 0060709709, 0060709710, 0060709711,
0060709719, 0060749170. 7C2100--0060707500, 0060707501, 0060709659.
7C6311--0060482936, 0060489182, 0060496750, 0060505790, 0060506316, 0060523417,
006055541633, 0060543824, 0060543825, 0060543826, 0060548258, 0060555712,
0060557290, 0060561310, 0060578814, 0060710970, 0060720149, 0060726624.
7M3882--0060551059, 0060572130, 0060710976, 0060738147, 0060746766.
7M3883--0060707663, 0060725281
RECALLING
FIRM/MANUFACTURER
Recalling Firm: B. Braun Medical, Inc.,
Allentown, PA
Manufacturer: B. Braun
Medical, Inc., Cherry Hill, NJ.
REASON Reports that the tear away introducer sheaths have
cracked hubs/handles and/or improper peeling of the sheath during
use.
VOLUME OF PRODUCT IN COMMERCE 1,105,700
cases
DISTRIBUTION Nationwide and Internationally
PRODUCT Keramos Ceramic Femoral
Heads. Product consists of ceramic femoral head and liner used in hip
replacement surgeries
CODE Catalog #
400-01-290/291/292/295/296/297/ 498-28-048
RECALLING
FIRM/MANUFACTURER Encore Medical, Lp, Austin, TX
REASON Labeling on the
Keramos Ceramic Femoral Heads and Liner indicates the product expiration date of
6 years instead of 5 years.
VOLUME OF PRODUCT IN COMMERCE 415
devices
DISTRIBUTION Nationwide
PRODUCT
a) PRIZM 2 DR, model
1861 Automatic Implantaable Cardioveter Defibrillator, Contents have been Sterilized with gaseous ethylene oxide,
b) CONTAK
Renewal 3 DS HE, model H177 CRT-D Cardiac Resynchronization Therapy
Defibrillator, Contents have been sterilized with gaseous ethylene oxide,
CODE
a) 263958, 264039, 264055, 264058,
264059, 264060, 264064, 264066, 264069, 264070,
264112, 264117 and
264119;
b) 508822, 508827 and 508862
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Guidant Corporation, Saint Paul,
MN
Manufacturer:
Guidant-Ireland, Clomel, Ireland.
REASON Devices were manufactured with PEEK insulation
material on the feed through wires and distributed prior to PMAS
approval.
VOLUME OF PRODUCT IN COMMERCE 16
units
DISTRIBUTION CA, IL, MI, MO, OR, and PA
PRODUCT Medtronic MIDAS REX
Legend High Speed Pneumatic System, Gold Touch Motor
CODE Serial #s: A0746, A2434, A2435, A2437, A2438, A3363,
A3364, A3365, A3366, A3370, A3371, A3659, A3660, A3661, A3662, A3664, A3665,
A3666, A3668, A4409, A4410, A4411, A4574, A4575, A4577, A4578, A4579, A4580,
A4581, A4582, A4583, A4584, A4586, A4587, A4588, A4589, A4590, A4591, A4593,
A5205, A5559, A5560, A5561, A5565, A5566, A5568, A5569, A5570, A5763, A5764,
A5765, A5766, A5767, A5787, A5788, A5789, A5790, A5791, A5792, A5793, A5794,
A5941, A5943, A5944, A5946, A5948, A5951, A5952, A5956, A5959, A6073, A6074,
A6075, A6078, A6079, A6081, A6429, A6430, A6431, A6432, A7374, A7376, A7378,
A7380, A7381, A7382, B0115, B0117, B0185, B0187, B0188, B0189, B0190, B0191,
B0192, B0193, B0194, B0195, B0196, B0197, B0198, B0199, B0200, B0201, B0204,
B0205, B0208, B0209, B0210, B0211, B0212, B0240, B0241, B0242, B1815, B1817,
B1818, B1819, B1861, B1862, B1865, B1866, B1868, B1869, B1870, B1871, B1908,
B1909, B1910, B1912, B1914, B1915, B1916, B1917, B1976, B1977, B1978, B2107,
B2109, B2110, B2113, B2114, B2115, B2116, B2117, B2118, B2119, B2122, B2124,
B2125, B2126, B2128, B2130, B2131, B2133, B2134, B2135, B2142, B2145, B2146,
B2147, B2148, B2150, B2404, B2700, B2701, B2702, B2704, B2705, B2708, B2709,
B2710, B2712, B2713, B2714, B2716, B2717, B2718, B2721, B2722, B2723, B2724,
B2725, B2735, B3171, B3174, T1518, T2419, T5712, T6686, T9728
RECALLING
FIRM/MANUFACTURER Power Surgical Solutions, Fort Wayne, TX
REASON Complaints
of finger control component breaking off and falling into open surgical
wound.
VOLUME OF PRODUCT IN COMMERCE 191
motors
DISTRIBUTION Nationwide and Japan, Mexico, Netherlands,
Canada, and Venezuela
PRODUCT Sequoia Oxymatic
electronic oxygen conservers, Models OM-302 and OM-311
CODE Not provided
RECALLING
FIRM/MANUFACTURER Chad Therapeutics Inc, Chatsworth, CA
REASON ìShot
sizeî below manufacturing specifications. Risk of less than the specified
quantity of oxygen delivered per pulse.
VOLUME OF PRODUCT IN
COMMERCE 150
DISTRIBUTION Nationwide, Canada, Sweden,
Norway, and Gibraltar
PRODUCT
a) ASY Brat 2 Procedure
Set, for blood recovery & autotransfusion, Catalog Number 007213100,
b) ASY, Brat 2 Pack Procedure Set, Catalog Number: 007213102
c) ASY Brat 2 Procedure Set, Catalog
Number: 007214100,
d) ASY, Brat Pack Procedure Set,
Catalog Number: 007214102,
e) ASY Brat 2 Procedure
Set, Catalog Number: 007214900,
f) ASY, Brat 2
Procedure Set, Castalog Number:007214901,
CODE
a) Lot Number: 0511600003, 0512300003, 0513000003,
0513700003, 0514400005;
b) Lot numbers 0511600004, 0512300004,
0513000005, 0513700004, 0514400006;
c) Lot Numbers 0511600001,
0511600002, 0512300001, 0512300002, 0513000002, 0513000001, 0513700001, 0513700002, 0514400002, 0514400003, 0514400004,
0515100185;
d) Lot
numbers 0511600006, 0512300005, 0513000006, 0513700007, 0513700005,
0514400007, 0514400008, 0515100189;
e) Lot Number 0513700009;
f) Lot
Numbers 0512300008, 0514400009
RECALLING FIRM/MANUFACTURER Cobe
Cardiovascular, Inc., Arvada, CO
REASON Packaging trays may have holes
in them as a result of the sealing process, which could compromise the sterility
of the product.
VOLUME OF PRODUCT IN COMMERCE 6,294
units
DISTRIBUTION Nationwide, Australia, Canada, Italy and
Japan
PRODUCT
a) Product consists of a
syringe used to inject fluids during an angiographic procedure for fluoroscopic imaging. Labeling is as follows:
Product Label ì***Argon
Medical Device***10cc Control Syringe FR/TR/FM w/ Reservoir SINGLE USE
ONLY***REF/REORDER NO. 093205***This device is designed for the
administration and removal of fluids***Quantity:
25ea***NON-STERILE *FURTHER PROCESSING REQUIRED***Eto (ethylene oxide)
Sterilization Recommended*** Carton Label ì***Argon Medical Device***10cc
Control Syringe FR/TR/FM w/ Reservoir SINGLE USE ONLY***REF/REORDER NO.
093205***This device is designed for the administration and removal of
fluids***Quantity: 250ea***NON-STERILE*FURTHER PROCESSING REQUIRED***Eto
(ethylene oxide) Sterilization
Recommended***
b)
Argon Medical Devices***CUSTOM MANIFOLD KIT***REF/REORDER NO.
194902A***CONTENTS: 1 3-Port Manifold, 500 PSI***1 ASY CDX3 Transducer***1 Stopcock Assy 1-Way w/
MLL***1 72'' Vented Spike Line***1 10cc Control
Syringe***1 M/F L/L PVC Line***
1 Stopcock Assy 4-way w/ MLL***1 Rotating
Adapter, M/M***1 35/150/FC/PTFE/3J/XTB Guidewire***1 Angio Flushing
Set***1 Zero Port Plug, Serrated***1 Monitor Line Labels***STERILE EO***STERILIZED BY
EtO***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE***
Carton Labeling: ***Argon Medical Devices***CUSTOM MANIFOLD
KIT***REF/REORDER NO. 194902A***Quantity: 10 ea***DISPOSABLE***SINGLE-USE***DO NOT RESTERILIZE
STERILE
EO***STERILIZED BY EtO***,
c) Product consists of a
syringe used to inject fluids during an angiographic procedure for
fluoroscopic
imaging. Labeling is as follows: Product Label ***Argon
Medical Device***REORDER NO./REF 193205*** 10cc Control Syringe FR/TR/FM w/
Reservoir***This device is designed for the administration and removal of
fluids***DISPOSABLE***SINGLE USE ONLY***DO NOT RESTERILIZE***STERILE***EO***STERILIZED BY
EtO***Sterile Unless Opened
or Damaged*** Carton Label ***Argon Medical Device***10cc Control
Syringe FR/TR/FM w/ Reservoir***This device is designed for the
administration and removal of fluids* REF/REORDER NO. 193205***Quantity: 25
ea
*STERILE***EO***STERILIZED BY EtO***DISPOSABLE ***SINGLE USE ONLY***DO
NOT RESTERILIZE***Sterile Unless Opened or Damaged***
d) Labeling is as follows: Product Labeling: ***Argon
Medical
Devices***MANIFOLD KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***EtO
STERILIZATION RECOMMENDED***Caution: For manufacturing, processing or
repacking.*** Carton Labeling: ''***Argon Medical Devices***MANIFOLD
KIT***SINGLE USE ONLY***REF/REORDER NO. 094337***Quantity: 20
ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide)
Sterilization Recommended***,
e) Labeling is as
follows: Product Labeling: ***Argon Medical Devices***12cc Control Syringe***FR/TR/RM w/ Reservoir***SINGLE USE
ONLY***REF/REORDER NO.
093209***This device is designed for the administraion and removal of fluids.***Quantity: 250 ea.***NON-STERILE*FURTHER
PROCESSING REQUIRED***Eto (ethylene oxide)
Sterilization Recommended****** Carton
Labeling: ***Argon Medical Devices***12cc Control
Syringe***FR/TR/RM w/
Reservoir***SINGLE USE ONLY***REF/REORDER NO. 093209***This device is designed for the administration and removal of
fluids.***Quantity: 250
ea***NON-STERILE*FURTHER PROCESSING REQUIRED***EtO (ethylene oxide)
Sterilization Recommended***
f) Labeling is as
follows: Product labeling: ***Argon Medical Devices***RE-ORDER NO./REF
193248***12cc Control Syringe***ST/FR/TR/FM w/Reservoir***This device
is designed for the
administraion and removal of
fluids.*** DISPOSABLE*SINGLE USE*DO NOT RESTERILIZE***
STERILE EO***STERILIZED BY
EtO*** Carton Labeling: ***Argon Medical Devices***12cc
Control Syringe***ST/FR/TR/FM W/ Reservoir***This device is designed for
the administration
and removal of fluids.***REF/REORDER NO.193248***Quantity: 25 ea.***STERILE
EO***
STERILIZED BY EtO***DISPOSABLE*SINGLE USE*DONOT RESTERILIZE***,
a) Lot number: 99442547;
b) Lot number: 99444872;
c)
Lot numbers: 99445447 and Lot number: 99445446;
d) Lot numbers: 99442306, Lot
number: 99443999 and Lot number: 99444179;
e) Lot number: 99440951, Lot
number: 99443816 and Lot number: 99443819;
f) Lot number:
99444008
RECALLING FIRM/MANUFACTURER Argon Medical Devices, Inc.,
Athens, TX
REASON The firm is recalling the product due to the
potential for air aspiration or fluid leakage from a faulty syringe
tip.
VOLUME OF PRODUCT IN COMMERCE 4,879
units
DISTRIBUTION Nationwide, Japan, Germany, and The
Netherlands
PRODUCT Orajel toddler Extra
Gentle Yellow Manual Toothbrush, Model 7531, barcode # 3 10310 32362 2. Made in
China -- The toothbrush is to be replaced every 3 months
CODE This product does not have lot numbers
assigned
RECALLING FIRM/MANUFACTURER
Recalling Firm: Del
Pharmaceuticals, Inc., Farmingdale, NY
Manufacturer: Yi Shing,
Hong Kong, China.
REASON Firm
received several consumer complaints that the elastomer head of the toothbrush
had separated (broke) from the handle during use and could pose a choking hazard
to children.
VOLUME OF PRODUCT IN COMMERCE 134,082 units
domestically, and 1,578 units internally as free
samples.
DISTRIBUTION Nationwide and PR
PRODUCT Rusch/MMG Urinary
Catheterization System, 14 Fr; the single use sterile kit contains a Rusch/MMG
Intermittent Catheter, gauze tissue, povidone iodine swabs, two vinyl gloves and
underpad; 100 kits per box, product number RLA-142-3
CODE Lot 002990-6, exp. 2007/03 and lot 002990-7, exp.
2007/02
RECALLING FIRM/MANUFACTURER
Recalling Firm: Teleflex
Medical, Bannockburn, IL
Manufacturer: Teleflex Medical, Nueva Laredo, Mexico.
REASON
There is a lack of assurance of
sterility for parts of both lots of product.
VOLUME OF PRODUCT IN
COMMERCE 62,000 units
DISTRIBUTION Nationwide
PRODUCT Puritan Bennett 840
Series Ventilator Power Supply, Model/Catalog Numbers: 4-076314-00; 4-076314-SP
CODE
All codes
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Puritan Bennett, Pleasanton,
CA
Manufacturer: Puritain Bennett, Galway,
Ireland.
REASON Some of the
screws from inside the power supply were loose or missing altogether.
Manufacturing defect at contract manufacturer, employee error, poor training,
improper inspection.
VOLUME OF PRODUCT IN COMMERCE 309
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Baxter Sabraset 6060
Administration Set with Pre-attached 250 mL Bag and Cassette, product
code 560500-250;
b) Baxter Sabraset 6060
Administration Set with Pre-attached 100 mL Bag and Cassette,
product
code 560500-100;
CODE
a) Lots 417521,
418481, 418744
b) Lots 417519, 417520, 418482, 418483, 418745
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter
Healthcare, Corp., Round Lake, IL
Manufacturer: Avail Medical Products, Tijuana, Mexico.
REASON
The inlet and outlet lines of
the administration set may be reversed, which would result in reverse
flow.
VOLUME OF PRODUCT IN COMMERCE 20,745
units
DISTRIBUTION Nationwide, Australia, Belgium, Canada and
Japan
PRODUCT
a) Baxter 6060
Multi-Therapy Infusion Pump, product code 2M9832, 606000-40, 606000-40L,
606000-40I;
b) Baxter 6060E Epidural Infusion Pump,
product code 2L9351 and 606000-40EL;
CODE All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare, Corp., Round
Lake, IL,
Manufacturer: Baxter Healthcare,
Corp., Singapore.
REASON There is
an overinfusion condition in the Intermittent mode where the pump may continue
to deliver at the higher dose rate instead of switching to the lower keep open
rate once the first dose is completed.
VOLUME OF PRODUCT IN
COMMERCE 34,000 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Medtronic Sofamor Danek
brand LT CAGE lumbar tapered fusion device implant 14 mm x 23 mm; Catalog number
8941423
CODE Lot W05C5509
RECALLING
FIRM/MANUFACTURER Warsaw Orthopedic, Inc., Warsaw, IN
REASON The product is
labeled as sterile, but this lot was not sterilized.
VOLUME OF PRODUCT IN
COMMERCE 140 units
DISTRIBUTION Nationwide and Canada
PRODUCT
a) ChemoSite Low
Profile, Implantable Low Profile Mini Catheter Venous Access System with
printed
Polyurethane Catheter and 7 French Introducer Kit Catalog
Number: 120011
b) ChemoSite Low Profile, Implantable Low
Profile Mini Catheter Venous Access System with printed
Polyurethane
Catheter and 9 French Introducer Kit Catalog Number: 120021
c) ChemoSite Low Profile, Implantable Low Profile Mini
Catheter Venous Access System with 9 French
Introducer Kit with Silicone
Catheter Catalog Number: 120025
d) ChemoSite
Catheter Introducer Kit with 9 French Peel-Away Sheath Catalog Number:
120039,
e) ChemoSite Implantable venous access sytem
with printed Polyurethane Catheter and 9 French Introducer
Kit Catalog
Number: 120045
f) ChemoSite Implantable venous access
sytem with printed silicone Catheter and 9 French Introducer Kit
Catalog
Number: 120066
g) ChemoSIte Cathteter Introducer Kit with
7 French Peel-Away Sheath Catalog Number: 120089,
h) ChemoSite Implantable venous access sytem with
printed
Polyurethane Catheter and 7 French Introducer
Kit Catalog Number: 120092
CODE
a) Lot Numbers: N4J395 N4K343;
b) Lot
Numbers: N4G435 N4J328 N4K344 N5A181;
c) Lot numbers: N4J52 N4J329
N4J379;
d) Lot Numbers: N4G110 N4H201 N4K213 N4L82 N4M302 N4M522;
e)
Lot Numbers: N4G22 N4G215 N4G436 N4J29 N4J212 N4K218 N4L258 N4M213;
f)
Lot Numbers: N4G293 N4H139 N4H439 N4J214 N4K53 N4K4245 N4L257 N4M214;
g)
Lot Numbers: N4K141 N4L84;
h) Lot Numbers: N4K54 N4K431 N4L485
N4M93
RECALLING FIRM/MANUFACTURER
Recalling Firm: United
States Surgical Corp., North Haven, CT
Manufacturer: B. Braun Medical, Inc., Cherry Hill, NJ.
REASON
The peel away introducer sheath
may have cracked hubs/handles and/or improper peeling of the sheath during
use.
VOLUME OF PRODUCT IN COMMERCE 8,473
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Baxter Interlink
System Minivolume Extension Set, product code 1C8290; 11", 0.86 mL Vol.,
with 2
injection sites and a male Luer Lock adapter;
b) Baxter Interlink System Minivolume Extension Set,
product
code 1C8462; 16î, 4.2 mL Vol., with 0.22
Micron Downstream High Pressure
Extended Life Filter, 2 injection sites and a male Luer Lock adapter
c) Baxter Interlink System Minivolume Extension Set,
product code 1C8483; 18î, 1.3 mL Vol., with 0.22
Micron Downstream
Filter, 2 injection sites and a male Luer Lock adapter;
d) Baxter Interlink System Y-Type Minivolume Extension
Set,
product code 1C8645; 9", 0.8 mL Vol., with 2
injection sites and a male Luer
Lock adapter;
e) Baxter Interlink System Y-Type
Minivolume Extension Set, product code 1C8689; 6î, 0.33 mL Vol., with
male Luer Lock adapter
CODE
a) Lots
GR217836, GR219071, GR224220, GR225490, GR227587;
b) Lots GR219444,
GR223255, GR224659, GR227140;
c) Lots GR224238, GR227579;
d) Lots
GR222042, GR224667, GR227173, GR228114;
e) Lot GD814186
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round
Lake, IL
Manufacturer: Baxter
Healthcare Corp., Cleveland, MS.
REASON Leaks and disconnection between the bifurcated
Y-site and the set tubing may occur and result in underdelivery of medication,
blood loss, and a breach of the sterile fluid pathway.
VOLUME OF PRODUCT
IN COMMERCE 25,160 sets
DISTRIBUTION AZ, GA, IL, MI, OH, PA,
SC, and TX
PRODUCT Panorama Patient
Monitoring Network Cardiac Arrhythmia Monitor
CODE All units on the market
RECALLING
FIRM Datascope Corp, Mahwah, NJ
REASON Upon the new release of
software, the firm started receiving reports of unexpected system failures in
the database subsystem related to virtual memory pages.
VOLUME OF PRODUCT
IN COMMERCE 70 units
DISTRIBUTION Nationwide, Belgium and
Italy
PRODUCT Disetronic D-Tronplus
Insulin Pump adapters; Ref 3000803; catalog reference number 0457243001 sold in
packages of ten adapters.
CODE All units with
the following lot numbers being used by patients 13 years of age or younger:
lots 4013674 through 4022628. The last affected lot expires in April
2007.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Roche
Diagnostics Corp., Indianapolis, IN
Manufacturer: Disetronic Medical Systems AG, Burgdorf, Switzerland.
REASON
The adapter valve may not
operate correctly, which may result in overdelivery of insulin in the first dose
after the adapter has been changed.
VOLUME OF PRODUCT IN
COMMERCE Unknown -- 107 pediatric patients use the
device
DISTRIBUTION Nationwide
PRODUCT Staarvisic II Sodium
Hyaluronate, 0.8 mL,
CODE Lot B04118C, Exp. Date
12/31/2005
RECALLING FIRM
Recalling Firm: Staar Surgical Co.
Inc., Monrovia, CA,
Manufacturer: Anika Therapeutics, Woburn, MA.
REASON
Sterility may be compromised.
VOLUME OF
PRODUCT IN COMMERCE 16,464
DISTRIBUTION Nationwide, Canada
and PR
PRODUCT Portable Oxygen
Generator
CODE All codes
RECALLING
FIRM/MANUFACTURER Inogen, Inc., Goleta, CA
REASON Firm plans to upgrade all
units to correct situations that could lead to interruption in oxygen
delivery.
VOLUME OF PRODUCT IN COMMERCE 920
units
DISTRIBUTION Nationwide
PRODUCT ACCU-CHEK Go Care Kit;
Catalog number 04470052001. Kit includes an ACCU-CHEK Go meter.
CODE
All units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp,
Indianapolis, IN,
Manufacturer: Sanmina
SCI, County Cork, Ireland.
REASON The meter may self-start without a sample having
been applied and report erroneous results without an error message if an undosed
test strip is bent upwards, and held upwards, while the meter is waiting for the
sample.
VOLUME OF PRODUCT IN COMMERCE 2,490
units
DISTRIBUTION Nationwide
PRODUCT Zimmer brand Versys Hip
System Femoral Head 12/14 taper, 32mm dia., neck length +0mm; Product
00-8018-032-02,
CODE Lot
60252787
RECALLING FIRM/MANUFACTURER
Recalling Firm: Zimmer,
Inc., Warsaw, IN,
Manufacturer: Zimmer Caribe, Inc., Mercedita, PR.
REASON Mislabeled as to dimensions; may be 12/14 taper, 28mm dia.,
neck length +3.5mm.
VOLUME OF PRODUCT IN COMMERCE 38
units
DISTRIBUTION Nationwide and Canada
PRODUCT BD #11 Bard Parker
Scalpel. A general use surgical blade, frequently used for ìstab incisionsî. A
non sterile, disposable, stainless steel blade. Reorder Number 371631,
CODE
Lot Number 4322604
RECALLING
FIRM
Recalling Firm: Becton Dickinson & Company, Franklin
Lakes, NJ
Manufacturer:
Peg Bandages, Inc., Las Piedras, PR.
REASON A small percentage of scalpels exhibited a ìdouble
bladeî condition.
VOLUME OF PRODUCT IN COMMERCE 48,000
units
DISTRIBUTION IL, TX, UT, VA, TN, IN, and PR
PRODUCT Roche Diagnostic Health
Wear brand Professional System for weight management; Catalog # 04344456001
CODE
All units
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics, Corp.,
Indianapolis, IN
Manufacturer: Body
Media, Inc., Pittsburgh, PA.
REASON Lack of adequate manufacturing
controls.
VOLUME OF PRODUCT IN COMMERCE 1,005
units
DISTRIBUTION Nationwide
PRODUCT Power Processor 3060
Tube Refrigerated Stockyard, P/N 6915556,
CODE Not specified
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter Inc., Brea, CA,
Manufacturer: I D S Co., Ltd., Bolden,
England.
REASON Device does not
maintain a uniform internal temperature within 2-8 C at warmer ambient
temperatures.
VOLUME OF PRODUCT IN COMMERCE 46
units
DISTRIBUTION Nationwide and Canada
WEEK ENDING AUGUST 27
PRODUCT
a) Baxter Colleague
Single Channel Volumetric Infusion Pumps; Made in Singapore; product codes
2M8151,
2M8151R, 2M8161, 2M8161R
b) Baxter Colleague
Triple Channel Volumetric Infusion Pumps; Made in Singapore; product codes
2M8153,
2M8153R, 2M8163, 2M8163R
CODE All
serial numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter
Healthcare, Corp., Round Lake IL
Manufacturer:
Baxter Healthcare, Corp., Singapore, Singapore.
REASON A hardware problem can cause internal
communications errors, which halt therapies, generate alarms and communication
failure codes.
VOLUME OF PRODUCT IN COMMERCE 344,074
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) VENTAK PRIZM AVT
model no. 1900, Atrial and Ventricular Therapies. Sterilized using gaseous ethylene oxide.
b) VITALITY
AVT, model A135 and A155.
Implantable Cardioverter Defibrillator. Atrial and Ventricular
Therapies. Sterilized using gaseous ethylene oxide.
CODE All serial numbers
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Guidant Corp., Saint Paul, MN
Manufacturer:
Guidant-Ireland, Clomel, Ireland
REASON Guidant is revising its
original recommendations set forth in the 06/17/05 physician letter because new
information indicates that one of the original recommendations can increase the
risk of a latching event, which may limit available therapy.
VOLUME OF
PRODUCT IN COMMERCE 20,905 (approximately 17,000 devices remain implanted
in US)
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Medtronic
Neurosurgery C/N 3805-014 Peelaway Introducer Sheath, Disposable 14 F,
b) Medtronic Neurosurgery C/N 3805-015 Peelaway Introducer Sheath, Disposable 15 F,
CODE
a) Lots: A46413, A6414, A48711, A49692, A53066,
A53867, A55500, A55753, A57046, A58460, A60519, A61343, A67224;
b)
Lots: A55754, A59282, A62361, A64132
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Medtronic Neurosurgery, Goleta,
CA
Manufacturer: B. Braun Medical, Inc., Allentown, PA,
REASON
Cracked hubs/handles
and/or improper peeling of the sheath during use.
VOLUME OF PRODUCT IN
COMMERCE 448 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT PASV Central Venous
Catheter, 7F, Cat. # CVC702IK, Model # M0001CVC702IK. The 7Fr PASV Central
Venous Catheter is a packaged configuration comprised of a silicone Central
Venous Catheter with PASV Valve, Guidewire, Syringe, Needle, Tunneler, Scalpel,
Sheath/Dilator, and caps
CODE 934445 exp.
2/28/2007; 942510 exp. 1/31/2007; 938122 exp. 3/31/2007; 935225 exp. 2/28/2007;
933703 exp 1/21/2007; 931401 exp. 12/31/2006; 929657 exp. 12/31/2006; 929435
exp. 12/31/2006
RECALLING FIRM/MANUFACTURER
Recalling Firm: Boston Scientific Corp.,
Natick, MA
Manufacturer: Boston Scientific
Corp., Glens Fall, NY
REASON Kits labeled to contain 0.028í guidewire contain
0.038í guidewire.
VOLUME OF PRODUCT IN COMMERCE 290
units
DISTRIBUTION Nationwide and UK
PRODUCT Tri-Plex Adapter, single
unit (MD-04000) or box of 25 (MD-04001) or case of 100 (MD-04002). Adaptor that
is coupled between an endotracheal tube and a ventilator. Device allows
practitioner to access the airway without having to disconnect the circuit.
Sterile, Single Use
CODE Lot number:
2005001
RECALLING FIRM/MANUFACTURER Medical Device Group Inc.,
Poway, CA
REASON Device separation presenting a
choking hazard. The plunger seal separated from the plunger.
VOLUME OF
PRODUCT IN COMMERCE 2,282 units
DISTRIBUTION Nationwide,
Brazil and Canada
PRODUCT Syndeo PCA Syringe Pump,
product codes 2L3113 and 2L3113R; Made in Singapore
CODE All serial numbers
RECALLING FIRM/MANUFACTURER
Recalling
Firm: Baxter Healthcare, Corp., Round Lake IL.
Manufacturer: Baxter Healthcare, Corp., Singapore, Singapore.
REASON
During an infusion in the
'Basal + PCA' or 'PCA only' modes, the SYNDEO pump may generate false Service
Code 919 or Service Code 920, which will cause the pump to stop the infusion.
Also, while attempting to turn on the device by pressing the On/Off key, the
pump may not power up properly.
VOLUME OF PRODUCT IN COMMERCE 4,392
units
DISTRIBUTION Nationwide and Canada
PRODUCT Newport HT50 All Purpose
Ventilator
CODE All serial numbers. Products
are identified by serial numbers on back of ventilators. Manufacturer states
serial numbers of ventilators involved in field correction may be obtained
through shipping records.
RECALLING FIRM/MANUFACTURER Newport
Medical Instruments, Inc., Costa Mesa, CA
REASON Lack of
alarm prior to shutdown.
VOLUME OF PRODUCT IN COMMERCE 3,654
units
DISTRIBUTION Nationwide and Internationally
PRODUCT UltraLite Vehicles
powered by Rascal Motorized Vehicles
CODE All
units distributed under Model Number UL370.
RECALLING
FIRM/MANUFACTURER Electric Mobility Corp., Sewell, NJ
REASON The
engager set screw may become loose. This problem may cause the potentiometer to
become off-center thus affecting the end users stopping
capabilities.
VOLUME OF PRODUCT IN COMMERCE 788
units
DISTRIBUTION Nationwide
PRODUCT Cytomics FC500 MPL with
MXP Software
CODE Versions 1.1 and
2.0
RECALLING FIRM/MANUFACTURER
Recalling Firm: Beckman Coulter,
Inc., Brea, CA
Manufacturer: Applied Cytometry
Systems, Dinnington, UK.
REASON Software anomaly. If the laser is shutdown or
fluctuates outside of the specification limits, the software continues to run
and will not indicate a laser failure, and could therefore cause erroneous
results.
VOLUME OF PRODUCT IN COMMERCE 36
units
DISTRIBUTION Nationwide
PRODUCT SmartCycler Diagnostic
Software for use with Cepheid brand SmartCycler Real Time PCR Thermocycler
CODE
All units with software code version
numbers: PN950-0101, Rev 1.7 and PN950-0108, Rev 1.7a
RECALLING
FIRM/MANUFACTURER Cepheid, Sunnyvale, CA
REASON A problem in the software
has the potential to be associated with the incorrect reporting of sample
results.
VOLUME OF PRODUCT IN COMMERCE 163
units
DISTRIBUTION Nationwide and Internationally
PRODUCT Regius-IM, The Regius
Image Manager for Centralized workflow and improved image quality software
CODE
All serial numbers
RECALLING
FIRM/MANUFACTURER Konica Medical Imaging, Inc, Wayne, NJ
REASON One feature of the software on some of the devices
which permits assembling three digital images into one image has occasionally
had problems aligning the three images
exactly.
VOLUME OF PRODUCT IN
COMMERCE 60 units
DISTRIBUTION Nationwide
PRODUCT DL2000 Data Manager
CODE
Not Applicable but refers to software
version 6.4.109f
RECALLING FIRM
Recalling Firm: Beckman
Coulter, Inc., Brea, CA
Manufacturer: Normand Informatique, Cedex, France.
REASON
Version v6.4.109f, any result designated
as ìcalculated chemistryî at DL2000 may upload to the LIS with an incorrect or
blank sample ID.
VOLUME OF PRODUCT IN COMMERCE 287
units
DISTRIBUTION Nationwide
PRODUCT Coagulation Factor VIII
Deficient Plasma (OTXW). Factor Deficiency Test
CODE Lot numbers: 503845A, 503846A, and
503847D
RECALLING FIRM/MANUFACTURER
Recalling Firm: Dade
Behring,
Inc., Newark DE
Manufacturer: Aventis Behring Gmbh, Marburg, Germany.
.
REASON Sample may exhibit falsely high
results.
VOLUME OF PRODUCT IN COMMERCE 3,255
packs
DISTRIBUTION Nationwide and Internationally