JANUARY 2008
WEEK ENDING JANUARY 5
PRODUCT
Ellex,
Eye Cubed, I 3 System-ABD Ultrasound Version 3.0 with Software Version 3.0 and
Biometry A-scan modality,
CODE
Serial numbers: V305-00510 V307-18205
V307-18405 V307-20309 V307-20409 V307-20609 V307-20809 V307-20909 V307-21409
V307-19605 V307-15703 V307-16404 V307-16504 V307-19805 V307-17304 V307-18105
V307-19105 V307-14303 V306-09910 V307-13902 V306-05705 V307-17104 V307-17004
V307-14203 V307-14903 V307-17502 V307-15203 V307-18305 V307-15503
V306-04605 V307-18905 V307-16003 V307-18605 V307-18004 V307-16904 V307-21009 V307-14803 V307-20005 V307-17904 V307-19505 V307-12302
V307-21109 V307-21509 V307-11101 V307-19305 V307-21209 V307-17404 V307-18705 V307-18505 V307-16304 V306-07108 V306-09209 V306-04405
V306-06408 V307-19205 V307-20209 V307-19005 V306-12104
V307-19905
RECALLING FIRM/MANUFACTURER Ellex, Inc.,
Sacramento, CA,
REASON Incorrect IOL calculations: software
behavior with Version 3.0 Eye Cubed Ultrasound systems running Biometry A-scan
enabled Version 3.0.0 software can cause incorrect IOL calculations. Incorrect
IOL calculations: software behavior with Version 3.0 Eye Cubed Ultrasound
systems running Biometry A-scan enabled Version 3.0.0 software can cause
incorrect IOL calculations.
VOLUME OF PRODUCT IN
COMMERCE 59 systems
DISTRIBUTION Nationwide
and
Internationally
PRODUCT Vortex®
VX, Port System, 9.6FR, REF/Part Number: P5455K, Catalog Number: P5455, Latex
Free, Sterile,
CODE Lot #:
30938
RECALLING FIRM/MANUFACTURER Rita Medical Systems,
Inc., Manchester, GA
REASON The
product may contain an incorrect size catheter.
VOLUME OF PRODUCT IN
COMMERCE 150 kits
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a) Precept Medical Products, Tape Fog Shield Surgical Mask Green
Fiberglass Free, Reorder #: 65-3322, non-sterile, 50/box,
5 box/case, b) Precept Medical Products, Foam Fog
Shield Surgical Mask Green Fiberglass Free, Reorder #:
65-3320, non-sterile, 25/box, 6 box/case, CODE
a) Lot Numbers: 1053430 through 1061090,
and 1060180, 1060190, 1060200, 1060230, 1060240,
1060250, 1060260, 1060270, 1060300, 1060310, 1060320, 1060440, 1060450, 1060460, 1060470, 1060480, 1060510, 1060520,
1060530, 1060660,
1060670, 1060680, 1060970, 1061000,
1061240, 1061250, 1061350, 1061360, 1061370, 1061390,
1061420, 1061440, 1061450, 1061530, 1061560, 1061570,
1061580, 1061590, 1061630, 1061640, 1061650, 1061670, 1061710, 1071720,
1061730, 1061790, 1061800, 1061810, 1061840, 1061850,
1061860, 1061870, 1062010, 1062020, 1062060, 1062070,
1062090, 1062120, 1062130, 1062190, 1062200, 1062210,
1062220, 1062360, 1062370, 1062390, 1062400, 1062440,
1062470, 1062510, 1062540, 1062560, 1062570, 1062580, 1062690, 1062700, 1062710, 1062720, 1062760, 1062770, 1062780, 1062790,
1062820, 1062850, 1062860, 1062890, 1062900, 1062910,
1062970, 1062980, 1063030, 1063040,
1063050, 1063060,
1063180, 1063190, 1063200, 1063260, 1063270, 1063280,
1063290, 1063330, 1063390, 1063400, 1063410, 1063420, 1063430, 1063450, 1063460, 1063470, 1063480, 1063500, 1070080, 1070090,
1070110, 1070120,
1070290, 1070300, 1070310, 1070320,
1070460, 1070470, 1070500, 1070510, 1070520, 1070530,
1070540, 1070600, 1070640, 1070650, 1070660, 1070850,
1070860, 1070870, 1070880, 1071000, 1071310, 1071430, 1071440, 1071450,
1071460, 1071480, 1071490, 1071500, 1071510, 1071520,
1071530, 1071550, 1071620, 1071650, 1071660, 1071670,
1071690, 1071700, 1071710, 1071720, 1071730, 1071740,
1071760, 1071770, 1071780, 1071790, 1071810, 1071830,
1071840, 1071850, 1071860, 1071870, 1071880, 1071900, 1071920, 1071930, 1071940, 1071950, 1071970, 1071980, 1071990, 1072000,
1072050, 1072060, 1072070, 1072080, 1072110, 1072120,
1072130, 1072180, 1072190, 1072200,
1072230, 1072250,
1072260, 1072350, 1072400, 1072410, 1072420, 1072460,
1072470, 1072480, 1072490, 1072500, 1072530, 1072540, 1072550, 1072560, and 1072570, and Lot Numbers 1062207 through 1071147
(only those lots in this
range with the last digit of "7"
(seven));
b) Lot Numbers: 1060800 through 1060890, 1060170, 1060180, 1060190,
1060200, 1060230, 1060240, 1060250, 1060260, 1060270,
1060300, 1060310, 1060320, 1060330, 1060340,
1060380, 1060390, 1060400, 1060410, 1060440, 1060450,
1060460, 1060470, 1060510, 1060520, 1060530, 1060540, 1060580, 1060590, 1060600, 1060610, 1060620, 1060650, 1060660, 1060670,
1060680, 1061170, 1061530, 1061560, 1061720, 1071730,
1061790, 1061880, 1061990, 1062000,
1062010, 1062070,
1062080, 1062230, 1062260, 1062270, 1062400, 1062410,
1062420, 1062470, 1062480, 1062540, 1062550, 1062560, 1062620,
1062630,
1062680, 1062690, 1062700, 1062760, 1063310, 1063320, 1063330, 1063340,
1063380, 1063390, 1070250, 1070260, 1070270, 1070330,
1070340, 1070360, 1070370, 1071370, 1071380, 1071420,
1071520, 1071590, 1071870, 1072010, 1072090, 1072140,
1072150, 1072180, 1072210, 1072220, 1072290, 1072300,
1072370, 1072390, 1072580
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Precept Medical Products, Inc.,
Arden, NC,
Manufacturer: Precept Medical Products Inc, Childersburg, AL.
REASON
Small slits under the
folds of the masks; thus they may not provide the protection necessary between
the patient and surgical staff.
VOLUME OF PRODUCT IN
COMMERCE 11,546,350
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
a)
Satellite Spinal System Primary User Group Reference Guide, 8 1/2 by 11 inch plastic binder,
b)
Satellite Spinal System Surgical Technique, LITSATFUSST7-IRN10612/087, and LIT (DRAFT) Medtronic,
c)
Medtronic Sofamor Danek, 9 mm Satellite Sphere CoCr, Size 9 mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx only,
d) Medtronic Sofamor
Danek, 10 mm Satellite Sphere CoCr, Size 10
mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx
only,
e) Medtronic Sofamor Danek, 11 mm Satellite
Sphere CoCr, Size 11 mm, Quantity 1each, Material Cobalt
Chrome, Sterile, Rx only,
f) Medtronic Sofamor Danek,
12 mm Satellite Sphere CoCr, Size 12 mm, Quantity 1 each,
Material Cobalt Chrome, Sterile, Rx only,
g) Medtronic
Sofamor Danek, 13 mm Satellite Sphere CoCr, Size 13 mm, Quantity
1 each, Material Cobalt Chrome, Sterile, Rx only,
h) Medtronic Sofamor
Danek, 14 mm Satellite Sphere CoCr, Size 14
mm, Quantity 1 each, Material Cobalt Chrome, Sterile, Rx
only,
i) Medtronic Sofamor Danek, 15 mm Satellite
Sphere CoCr, Size 15 mm, Quantity 1 each, Material Cobalt
Chrome, Sterile, Rx only,
j) Medtronic Sofamor Danek,
16 mm Satellite Sphere CoCr, Size 16 mm, Quantity 1 each,
Material Cobalt Chrome, Sterile, Rx only,
k) Medtronic
Sofamor Danek, Satellite System Sphere PEEK, Size 10 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only,
l) Medtronic Sofamor
Danek, Satellite System Sphere PEEK, Size
11 mm, Material PEEK-Optima, quantity 1, Sterile, Rx
only,
m) Medtronic Sofamor Danek, Satellite System
Sphere PEEK, Size 12 mm, Material PEEK-Optima, quantity
1, Sterile, Rx only,
n) Medtronic Sofamor Danek,
Satellite System Sphere PEEK, Size 13 mm, Material
PEEK-Optima, quantity 1, Sterile, Rx only,
o) Medtronic
Sofamor Danek, Satellite System Sphere PEEK, Size 14 mm,
Material PEEK-Optima, quantity 1, Sterile, Rx only,
p) Medtronic Sofamor
Danek, Satellite System Sphere PEEK, Size
15 mm, Material PEEK-Optima, quantity 1, Sterile, Rx only,
q) Medtronic Sofamor
Danek, Satellite System Sphere
PEEK, Size 16 mm, Material PEEK-Optima, quantity 1,
Sterile, Rx only,
r) Medtronic Sofamor Danek, 8 mm
Curette, size 8 mm, Material Stainless Steel/Radel,
quantity 1 each, Non-sterile, Rx only,
s) Medtronic
Sofamor Danek, 8 mm Trial, size 8 mm, Material Stainless Steel/Radel, quantity 1 each, Non-sterile, Rx only,
CODE
a) All manuals; the manuals were not
coded;
b) All (US versions) guides/techniques; The Surgical Technique and
Manual are not coded;
c) All Lots to include:
W05K0556, W05K1614, W06A3260;
d) All Lots to include: W05K0134, W05K0543,
W05K0560, W05K0565, W05K1572, W05K1573, W05K1575;
e)
All Lots to include: W05K0144, W05K0552, W05K0553, W05K0554, W05K0567, W05K0572, W05K0722;
f) All Lots to include:
W05K0541, W05K0542, W05K0550, W05K0551, W05K0558,
W05K0731, W06A0842;
g) All Lots to include: W05K0132, W05K0557, W05K1576,
W05K1595, W05K2449, W06A0915;
h) All Lots
to include: W05K0561, W05K0582, W05K1920, W06A2074,
W07H0210;
i) All Lots to include: W05K0562, W05K0566, W05K1593,
W06A2809;
j) All Lots to include: W05K0135, W05K0564, W05K1016,
W06A1100;
k) All Lots to include: LX52, MA67;
l) All Lots to include:
LX53, LX59, MG73, MY47, MY49, NC36, ND61, NE27;
m) All Lots to include: LX54,
LX60, MA68, MG74, NB26, NE28, NF61;
n) All Lots to include: LX55, LX61, MA69,
MG75, NB27, ND62, NE29, NF62;
o) All Lots to include: LX56, LX62, MA70, MG76,
NB28, ND63, NE30q);
p) All Lots to include: LX57, LX63, MA71, MG77, NB29,
NE31;
q) All Lots to include: LX58, MA72, MA98, MY48, NB30, NE32;
r) All
Lots to include: NM04H015, NM04H015Z, NM04H031, NM04J023,
NM04J0231;
s) ALL LOTS to include: NM04H0021, NM04H0051, NM04H005Z,
NM04H0321
RECALLING FIRM/MANUFACTURER Medtronic Sofamor
Danek USA Inc, Memphis, TN,
REASON Marketed without approval: The
surgical technique includes reference to an 8mm Trial and 8mm Curette, while the
cleared -510 (k)- device only includes spheres between 9.5 and 19
mm.
VOLUME OF PRODUCT IN COMMERCE 200 to 300 manuals,
1,140 instruments and
implants
DISTRIBUTION Nationwide
PRODUCT HUDSON
RCI®, Variable Concentration, Large Volume Nebulizer,
Catalog Number (REF) 1770 and 41770, Rx Only,
CODE Lot Numbers: 49069, 50069, 51069, 52069,
53069, 01079, 02079, 03079, 04079, 06079, 12079, 1279R, 13079, 15079, 16079,
17079, 17079R, 18079, 19079, 19079R and 20079; and Lot Numbers: 50069, 52069,
01079, 06079, 16079, 17079, 17079R, and 18079
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Teleflex Creek Dr.
Durham, NC,
Manufacturer:
Teleflex Medical, Nueva Laredo, Mexico.
REASON Decreased in flow output; through the nebulizer -
(when used at higher oxygen concentration settings, this decrease in flow, may
lower the oxygen concentration inspired by the patient).
VOLUME OF
PRODUCT IN COMMERCE 215656
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
COULTER LH750 Analyzer, Part Number: 6605632, Hematology analyzer,
b) COULTER LH780 Analyzer, Part
Number: 723585, Hematology analyzer,
c) COULTER LH 500 Series System, Part Number: 178833, Hematology
analyzer,
d) COULTER
GEN*S System, Part Number: 6605381, Hematology analyzer,
CODE
All software
versions
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Beckman Coulter Inc, Brea, CA,
Manufacturer:
Beckman Coulter, Inc., Miami, FL.
REASON Patient Mis-identification can occur: 1) - When a
positive identifier (Sample ID or Cassette/Position) is manually edited to a
positive identifier that is already in the To Do list. The workstation will
accept the entry and no error message will be generated, creating 2 samples with
the identical positive identifier.2) - When manually entering a Patient ID,
if a blank space is entered between the characters in the Patient ID field, the
system will only accept the characters before the space.
VOLUME OF
PRODUCT IN COMMERCE 3,973 units in the US; 321 units in
Canada
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Biomet Optigun Cement Gun, non-sterile; REF 419300 and REF 4193 (in Europe),
b) Biomet Optigun Cement Gun,
Ratchet, non-sterile; REF 419500 and REF 4195 (in
Europe),
CODE
a) All units,
including lots 105300, 007602, 011900, 014300, 014900, 103500, 209700, 219100, 232000, 306900, 331600, 520800, 526200, 610000,
619600, 644100, 007600, 007601, 007603, 007604, 011900,
014300, 014900, 014901, 020700, 024100, 103500, 105300,
109004, 123100, 206100, 209700, 219100, 228600, 229200,
232000, 306900, 307000, 317200, 322800, 331600, 403800, 406800, 411200, 411300, 413100, 415000, 418200, 421100, 423900,
429200, 432300, 437300, 443200, 503700, 506800, 511200,
520800, 526200, 545200, 552000,
644100, 645700, 645800,
708600, 708700 and 999999;
b) All units including lots 429900, 642100 and
647700
RECALLING FIRM/MANUFACTURER Biomet, Inc. Warsaw,
IN,
REASON Loose Screw Component: A screw may come loose and
fall from the device during use, and result in implantation with the bone
cement.
VOLUME OF PRODUCT IN COMMERCE 6,590
units
DISTRIBUTION Nationwide, Canada and
Japan
PRODUCT
a)
Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer Application that can run on all Gemini
TFs, GXLs and EBW Workstations. (The
product is a software application that is installed in
Philips Medical System CT scanners.),
b) Philips Medical Systems, Cardiac Viewer or Pulmonary Viewer
Application that can run on all Brilliance CT scanners
using software versions 2.0 through V 2.2.5 and all EBW
workstations using software versions 2.0 through V3.5.2. (The product is a software application that is installed in Philips Medical
System CT scanners.)
CODE For 16 slice, 16 slice Big Bore, 40
slice, and 64 slice Brilliance CT scanners the affected software application
versions are: 2.0, 2.0.2, 2.2, 2.2.1, 2.2.2, and 2.2.5. For Extended Brilliance
Workspace the affected software application versions are: 2.0.0, 2.0.1, 2.0.50,
2.1.0, 3.0.0, 3.0.1, 3.0.2, 3.5, and 3.5.2
RECALLING
FIRM/MANUFACTURER Philips Medical Systems (Cleveland), Inc.,
Cleveland, OH
REASON Incorrect Measurement: Incorrect
measurement will occur when the operator uses the distance or area measurement
function, such as Graphic Tool line or ROI on zoomed and batch saved images from
the Cardiac Viewer or Pulmonary Viewer and then views them in the CT Viewer or
on a PACS System.
VOLUME OF PRODUCT IN COMMERCE 2,544
units
DISTRIBUTION Nationwide and
Canada
PRODUCT
a)
Roche Ammonia/Ethanol/CO2 Calibrator for use in conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111 and cobas c 501 clinical
chemistry analyzers; Catalog No. 20751995190,
b) Roche Ammonia/Ethanol/CO2 Control N (Normal) for use in
conjunction with Roche/Hitachi, COBAS INTEGRA, cobas c111
and cobas c 501 clinical chemistry analyzers; Catalog No.
20752401190, c) Roche Ammonia/Ethanol/CO2 Control A
(Abnormal) for use in conjunction with Roche/Hitachi,
COBAS INTEGRA, cobas c111 and cobas 46250 c 501 clinical
chemistry analyzers; Catalog No. 20753009190,
CODE
a) Lot No: 179070-01 and 179070-02;
exp. 4/30/2008;
b) Lot No: 178993-01 and 178993-02; exp. 3/31/2008;
c)
Lots No: 179021-01 and 179021-02; exp. 3/31/2008
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Roche Diagnostics Corp.,
Indianapolis, IN,
Manufacturer: Microgenics
Corp., Fremont, CA.
REASON High Quality Control Recovery: Undetected
high quality control recovery in bicarbonate assay.
VOLUME OF PRODUCT
IN COMMERCE 4,011
units
DISTRIBUTION Nationwide
PRODUCT
MicroBiologics; P. vulgaris, DuoPacksl Product Catalog Number:
0691P; ARCC 0427; Exp 2008-9; (Proteus vulgaris, Kwik-Stick, Cat. No. 0691P),
CODE
Lot No. :
691295
RECALLING FIRM/MANUFACTURER Microbiologics, Inc.,
Saint Cloud, MN
REASON Mislabeled: DuoPacks of Proteus
vulgaris contained Listeria monocytogenes instead of the labeled Proteus
vulgaris.
VOLUME OF PRODUCT IN COMMERCE 20
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Life+cel, Replacement Battery for Cardiac Science Powerheart AED G3, Lithium; Sulfur Dioxide, OEM P/N: 9146-001, voltage 12V, 7.5 amps,
Part #: 7L877,
b) Life+cel,
Replacement battery for Cardiac Science FirstSave Survivalink, Lithium Sulfur Dioxide, Voltage 12V, 7.5 Amps, OEM P/N: 9141-001,
Part Number: 2L561,
CODE
a) All Replacement batteries;
b) All
Batteries
RECALLING FIRM/MANUFACTURER BatteryZone, Inc.,
Somerset, NJ,
REASON Marketed
without 510 (K) approval.
VOLUME OF PRODUCT IN
COMMERCE 118 batteries part # 2L561; 24 batteries Part #
7L877
DISTRIBUTION Nationwide
PRODUCT
a)
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 30 mm, Catalog Number: A000137000,
b)
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, Catalog Number: A000138000,
c)
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP Valve 10, 22/18 mm, 30mm connector, Catalog Number: A137001000,
d)
Ambu, Positive End Expiratory Pressure (PEEP) Valves, PEEP
Valve Spare Part, Catalog Number: A137000501,
CODE
a) Lot Numbers: 000026, 000037,
000097, 010026, 010077, 020006, 020026, 030046, 040016,
and 020095;
b) Lot Number: 010017;
c) Lot Numbers: 030046, and
040056;
d) Lot Number: 030005
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Ambu Inc, Glen Burnie, MD,
Manufacturer: Ambu A/S,
Ballerup, Denmark.
REASON Lower pressure than expected: Medical device for
respiratory care may leak and not register accurate flow settings that affect
patient respiration.
VOLUME OF PRODUCT IN COMMERCE 197
units
DISTRIBUTION Nationwide
WEEK ENDING JANUARY 12
PRODUCT Cardinal
Health Alaris Pump Module (formerly Medley Pump Module), Model 810. All Alaris
Pump modules shipped prior to September 27, 2007 are subject to this recall.
CODE
Serial Numbers: Affected Ranges
2326101 to 12492744; 12492756 to 12504708; 12504710 to 12507035; 12507042 to
12515453; 12515455 to 12618060; 12518062 to 12538350; 12538352 to 12547112;
12547114 to 12554430; 12554432 to 12555569; 12555574 to 12561325; 12561327 to
12564066; 12564068 to 12567998; 12568000 to 12571511; 12571521 to 12571809;
12571812 to 12572416; 12572425 to 12572530; 12572532 to 12572593; 12572595 to
12574101; 12574103 to 12575903; 12575905 to 12577208; 12577211 to 12577426;
12577429 to 12577597; 12577599 to 12578297; 12578299 to 12579448; 12579450 to
12583418; 12583420 to 12583440; 12583442 to 12583736; 12583738 to 12587206;
12587211 to 12590508; 12590533 to 12591688; 12591690 to 12591742; 12591744 to
12593449; 12593451 to 12594240; 12594242 to 12594422; 12594424 to 12594426;
12594428 to 12594603; 12594605 to 12594631; 12594633 to 12594889; 12594906 to
12595917; 12595919 to 12596254; 12596266 to 12596298; 12596300 to 12597075;
12597077 to 12597134; 12597136 to 12597176; 12597178 to 12597227; 12597244 to
12597404; 12597418 to 12597443; 12597457 to 12597537; 12597543 to 12597677;
12597699 to 12597701; 12597703 to 12598020; 12598022 to 12598103; 12598105 to
12598143; 12598145 to 12598168; 12598170 to 12598172; 12598174 to 12598269;
12598271 to 12598300; 12598302 to 12598319; 12598322 to 12598350; 12598352 to
12598388; 12598390 to 12598393; 12598395; 12598397 to 12598401; 12598403 to
12598414; 12598425; 12598429 to 12598438; 12598441 to 12598581; 12598583 to
12598588; 12598592 to 12598662; 12598665 to 12598667; 12598669 to 12598684;
12598686 to 12598733; 12598735; 12598737 to 12598787; 12598789 to 12598795;
12598797 to 12598827; 12598829 to 12598846; 12598848 to 12598864; 12598866 to
12598872; 12598881; 12598883 to 12598888; 12598890 to 12598892; 12598894 to
12599023; 12599025 to 12599027; 12599033; 12599036; 12599038 to 12599040;
12599042 to 12599046; 12599048 to 12599071; 12599074; 12599076 to 12599083;
12599085 to 12599086; 12599089 to 12599090; 12599092 to 12599093; 12599101;
12599106 to 12599107; 12599109; 12599111 to 12599113; 12599115 to 12599117;
12599122; 12599124 to 12599150; 12599152 to 12599154; 12599158 to 12599161;
12599163 to 12599165; 12599169 to 12599201; 12599204; 12599206; 12599209 to
12599210; 12599214; 12599218; 12599220 to 12599222; 12599234; 12599237; 12599240
to 12599241; 12599252; 12599254; 12599256; 12599258; 12599263 to 12599266;
12599303; 12599313 to 12599314; 12599316 to 12599324; 12599329 to 12599331;
12599341; 12599347; 12599357 to 12599359; 12599362 to 12599370; 12599372;
12599379 to 12599382; 12599385 to 12599387; 12599390; 12599392 to 12599454;
12599465 to 12599468; 12599476 to 12599505; 12599541 to 12599619; 12599621 to
12599668; 12599672; 12599674 to 12599723; 12599725 to 12599754; 12599756 to
12599845; 12599847 to 12599874; 12599876 to 12602723; 12602729 to 12602926;
12602944 to 12603127; 12603427 to 12603462; 12603472 to 12603550; 12603552 to
12604635; 12604637 to 12604638; 12604640 to 12604653; 12604662 to 12604715;
12604717 to 12604718; 12604723; 12604725 to 12604726; 12604728 to 12604731;
12604733 to 12604744; 12604749 to 12604985; 12604996 to 12605071; 12605073 to
12605340; 12605342 to 12605384; 12605386 to 12605411; 12605424 to 12605503;
12605510 to 12605519; 12605526 to 12605720; 12605722 to 12605778; 12605780 to
12605818; 12605825; 12605827 to 12605855; 12605857 to 12606012; 12606015;
12606018 to 12606022; 12606024; 12606027; 12606029 to 12606103; 12606105 to
12606148; 12606150 to 12606152; 12606154 to 12606163; 12606165 to 12606171;
12606173 to 12606262; 12606264 to 12606278; 12606280 to 12606399; 12606407 to
12606409; 12606412 to 12606417; 12606420; 12606425; 12606431 to 12606437;
12606439 to 12606518 ; 12606531 to 12606589; 12606591 to 12606606; 12606608 to
12606627; 12606630; 12606639 to 12606640; 12606642 to 12606646; 12606648 to
12606650; 12606652 to 12606684; 12606686 to 12606723; 12606733 to 12606755;
12606757; 12606759 to 12606770; 12606791 to 12606794; 12606798 to 12606799;
12606802 to 12606807; 12606809 to 12606820; 12606822 to 12606823; 12606830 to
12606853; 12606855; 12606878 to 12606880; 12606882 to 12606895; 12606898 to
12606932; 12606934 to 12606947; 12606952 to 12606972; 12606974 to 12606980;
12606982 to 12606983; 12606985 to 12606986; 12606988 to 12606989; 12606991 to
12606993; 12607015 to 12607027; 12607035 to 12607036; 12607039; 12607041 to
12607043; 12607055; 12607058; 12607066 to 12607127; 12607129; 12607131; 12607134
to 12607137; 12607139; 12607141 to 12607155; 12607157 to 12607158; 12607160 to
12607256; 12607258 to 12607260; 12607262 to 12607299; 12607301 to 12607350;
12607352 to 12607418; 12607420 to 12607429; 12607431; 12607435; 12607437 to
12607458; 12607461 to 12607464; 12607466; 12607472 to 12607473; 12607475 to
12607485; 12607487 to 12607574; 12607576 to 12607632; 12607634 to 12607733;
12607735 to 12607741; 12607743 to 12607747; 12607749 to 12607817; 12607820 to
12607826; 12607828 to 12607846; 12607849 to 12607853; 12607860 to 12607863;
12607865 to 12607866; 12607868 to 12607925; 12607931; 12607941 to 12608002;
12608004; 12608013 to 12608015; 12608019; 12608022 to 12608031; 12608033 to
12608037; 12608039; 12608041 to 12608118; 12608126 to 12608127; 12608129 to
12608194; 12608196 to 12608261; 12608263 to 12608267; 12608269 to 12608343;
12608356; 12608358 to 12608360; 12608362 to 12608366; 12608368 to 12608377;
12608379 to 12608380; 12608397 to 12608398; 12608400 to 12608402; 12608404 to
12608408; 12608411 to 12608423; 12608426 to 12608428; 12608430; 12608444;
12608446 to 12608447; 12608462 to 12608474; 12608487 to 12608546; 12608548 to
12608554; 12608556 to 12608558; 12608560 to 12608575; 12608577 to 12608578;
12608580 to 12608596; 12608603 to 12608611; 12608613 to 12608616; 12608618;
12608621; 12608624 to 12608665; 12608667 to 12608693; 12608696 to 12608706;
12608718 to 12608724; 12608727; 12608731 to 12608758; 12608762 to 12608766;
12608770 to 12608774; 12608776 to 12608811; 12608813 to 12608825; 12608828 to
12608894; 12608898 to 12608901; 12608903 to 12608945; 12608948 to 12608972;
12608974 to 12609112; 12609136 to 12609155; 12609157; 12609159 to 12609162;
12609189 to 12609255; 12609257 to 12609262; 12609264 to 12609285; 12609288 to
12609302; 12609304 to 12609305; 12609307 to 12609309; 12609311 to 12609332;
12609334 to 12609356; 12609369 to 12609371; 12609375; 12609382 to 12609389;
12609393 to 12609440; 12609442; 12609445 to 12609449; 12609451; 12609453;
12609455 to 12609467; 12609469 to 12609478; 12609480 to 12609810; 12609812 to
12609853; 12609855 to 12609869; 12609871 to 12609926; 12609928; 12609945 to
12610030; 12610035 to 12610037; 12610039; 12610042 to 12610043; 12610047 to
12610103; 12610105 to 12610131; 12610133 to 12610145; 12610147 to 12610148;
12610150 to 12610151; 12610153 to 12610160; 12610172 to 12610178; 12610180 to
12610181; 12610183 to 12610208; 12610216 to 12610222; 12610224 to 12610225;
12610227; 12610229 to 12610231; 12610250 to 12610227; 12610279 to 12610281;
12610283; 12610295 to 12610321; 12610324 to 12610332; 12610334 to 12610356;
12610358 to 12610376; 12610378 to 12610383; 12610386 to 12610409; 12610411 to
12610421; 12610424 to 12610452; 12610454; 12610456 to 12610484; 12610497 to
12610583; 12610585 to 12610634; 12610636 to 12610641; 12610644; 12610647 to
12610669; 12610672 to 12610679; 12610692 to 12610699; 12610710 to 12610784;
12610795 to 12610798; 12610800 to 12610848; 12610850 to 12610870; 12610872;
12610893 to 12611013; 12611015 to 12611017; 12611029; 12611031 to 12611034;
12611037 to 12611044; 12611046 to 12611047; 12611049 to 12611078; 12611080 to
12611082; 12611084 to 12611106; 12611109 to 12611111; 12611128 to 12611129;
12611132 to 12611147; 12611149; 12611152; 12611154 to 12611158; 12611161 to
12611162; 12611164 to 12611194; 12611196 to 12611203; 12611304; 12611308 to
12611309; 12611311 to 12611312; 12611333 to 12611336; 12611338 to 12611341;
12611343; 12611345 to 12611346; 12611350 to 12611354; 12611357; 12611403 to
12611405; 12611410 to 12611411; 12611421 to 12611422; 12611427 to 12611428;
12611430; 12611442; 12611445 to 12611447; 12611451 to 12611460; 12611463 to
12611467; 12611471 to 12611478; 12611483; 12611488 to 12611489; 12611499 to
12611500; 12611502; 12611505 to 12611522; 12611524 to 12611526; 12611528 to
12611529; 12611532; 12611534 to 12611535; 12611538 to 12611550; 12611553 to
12611557; 12611561 to 12611563; 12611565 to 12611591; 12611593; 12611634;
12611641 to 12611643; 12611646 to 12611679; 12611684 to 12611686; 12611690 to
12611693; 12611695 to 12611697; 12611733 to 12611735; 12611739 to 12611741;
12611748 to 12611783; 12611791 to 12611794; 12611799 to 12611803; 12611805;
12611818; 12611820; 12611825 to 12611828; 12611830 to 12611832; 12611849 to
12611852; 12611854; 12611862; 12611865 to 12611878; 12611892 to 12611991;
12612002 to 12612003; 12612005 to 12612015; 12612017; 12612019; 12612021 to
12612022; 12612024; 12612026 to 12612064; 12612066 to 12612082; 12612084 to
12612089; 12612091; 12612093; 12612095 to 12612098; 12612101 to 12612123;
12612128 to 12612132; 12612134 to 12612135; 12612154 to 12612163; 12612165 to
12612190; 12612193 to 12612194; 12612196 to 12612199; 12612201 to 12612219;
12612222; 12612224 to 12612225; 12612227 to 12612230; 12612235 to 12612237;
12612239 to 12612267; 12612269 to 12612280; 12612282 to 12612290; 12612293 to
12612305; 12612307 to 12612321; 12612335 to 12612337; 12612395 to 12612397;
12612399; 12612401 to 12612404; 12612407 to 12612415; 12612417 to 12612419;
12612421 to 12612428; 12612430 to 12612431; 12612433; 12612435 to 12612439;
12612460 to 12612463; 12612491; 12612498; 12612506 to 12612509; 12612511;
12612519; 12612521; 12612524 to 12612527; 12612541 to 12612542; 12612544 to
12612568; 12612570; 12612573; 12612575; 12612578 to 12612616; 12612618 to
12612627; 12612636; 12612638 to 12612639; 12612643 to 12612649; 12612656 to
12612663; 12612665; 12612680 to 12612690; 12612692; 12612703; 12612713 to
12612728; 12612735 to 12612758; 12612760 to 12612764; 12612766 to 12612772;
12612775 to 12612784; 12612786 to 12612794; 12612797 to 12612810; 12612812 to
12612815; 12612817 to 12612821; 12612823 to 12612933; 12612935 to 12612939;
12612945; 12612948 to 12612958; 12612960 to 12612962; 12612965 to 12612968;
12612970 to 12612976; 12612978 to 12612989; 12612991 to 12613002; 12613004 to
12613021; 12613023 to 12613024; 12613027 to 12613028; 12613030 to 12613034;
12613036; 12613038 to 12613046; 12613048 to 12613050; 12613056; 12613060 to
12613065; 12613067 to 12613076; 12613078 to 12613079; 12613083 to 12613084;
12613087 to 12613088; 12613092; 12613098; 12613102; 12613104 to 12613105;
12613110; 12613114; 12613117 to 12613120; 12613123; 12613132 to 12613134;
12613137; 12613140 to 12613141; 12613145; 12613149; 12613152; 12613155 to
12613156; 12613160 to 12613161; 12613165 to 12613168; 12613204; 12613227;
12613238; 12613264 to 12613265; 12613274; 12613277; 12613336; 12613383 to
12613406; 12613412 to 12613413; 12613416; 12613419; 12613426; 12613430; 12613442
to 12613443; 12613449; 12613470; 12613475; 12613531; 12613587; 12613605;
12613644 to 12613645; 12613651; 12613655; 12613768 to 12613769; 12613797 to
12613813; 12613815 to 12613818; 12613821 to 12613839; 12613873; 12613876 to
12613883; 12613890; 12613893 to 12613894; 12613896; 12613898; 12613938; 12613940
to 12613954; 12613979 to 12613981; 12613989 to 12613990; 12613992 to 12613999;
12614001; 12614003 to 12614025; 12614027; 12614037; 12614039; 12614116;
12614118; 12614125; 12614130; 12614133; 12614138; 12614145; 12614147; 12614174
to 12614175; 12614236; 12614240; 12614247; 12614259 to 12614261; 12614276;
12614297; 12614324 to 12614325; 12614354; 12614365; 12614378; 12614403;
12614405; 12614424; 12614475; 12614700; 12614981; 12614985; 12614989; 12614991;
12615004; 12615023 to 12615024; 12615026; 12615038; 12615055; 12615097;
12615109; 12615121; 12615133; 12615159; 12615226; 12615276; 12615290; 12615345
to 12615346; 12615363; 12615410; 12615412; 12615416 to 12615417; 12615419;
12615423; 12615425 to 12615426; 12615442; 12615466; 12615468; 12615497;
12615596; 12615601; 12615609 to 12615610; 12615615; 12615680; 12615686 to
12615688; 12615719 to 12615720; 12615722 to 12615723; 12615727; 12615736;
12615738; 12615872; 12615888; 12615898 to 12615900; 12615913 to 12615937;
12615952; 12615961 to 12615962; 12615964; 12615994; 12615996; 12616012;
12616018; 12616043 to 12616044; 12616090; 12616098; 12616109 to 12616113;
12616131; 12616179; 12616212 to 12616214; 12616245; 12616267; 12616276;
12616323; 12616379 to 12616383; 12616385; 12616387 to 12616389; 12616402 to
12616403; 12616411; 12616444; 12616452 to 12616453; 12616457; 12616459 to
12616476; 12616478; 12616493; 12616496 to 12616510; 12616519 to 12616520;
12616542; 12616544 to 12616545; 12616550; 12616585; 12616590; 12616615; 12616617
to 12616618
RECALLING FIRM/MANUFACTURER Cardinal Health
303 Inc DBA Alaris Products, San Diego, CA
REASON Inaccurate flow rate;
related to misassembled (missing, bent or broken) springs during the
manufacturing or servicing of the mechanism assembly.
VOLUME OF
PRODUCT IN COMMERCE 203,277
units
DISTRIBUTION Nationwide and Internationally
PRODUCT
a)
Biograph 16, Biograph PET/CT Scanner, Catalog No. 872858, b) Biograph 40 - 3 Ring, Biograph PET/CT Scanner, Catalog No.
10097233,
c) Biograph 40
TruePoint, Biograph PET/CT Scanner, Catalog No. 10097303,
d) Biograph 6, Biograph PET/CT Scanner, Catalog No.
8728854,
e) Biograph 6, Biograph PET/CT Scanner, Catalog No. 8728573,
f) Biograph 64-3 Ring, Biograph
PET/CT Scanner, Catalog No. 8727450,
g) Biograph DUO LSO, Biograph PET/CT Scanner, Catalog No.
8728813,
CODE
a) Serial Numbers: 1300, 1301, 1302,
1303, 1305, 1306, 1307, 1308, 1309, 1310, 1311, 1312, 1313, 1315,
1316, 1317, 1318, 1319, 1320, 1321, 1322, 1323, 1324, 1325, 1326, 1327, 1328,
1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336, 1337, 1338, 1340, 1341, 1342,
1343, 1344, 1345, 1346, 1347, 1348, 1349, 1350, 1351, 1352, 1353, 1354, 1355,
1356, 1357, 1359, 1360, 1361, 1362, 1363, 1364, 1365, 1366, 1367, 1368, 1369,
1370, 1371, 1372, 1373, 1374, 1375, 1376, 1377, 1378, 1379, 1380, 1381, 1382,
1383, 1384, 1385, 1386, 1387, 1388, 1389, 1391, 1392, 1393, 1394, 1395, 1396,
1397, 1398, 1399, 1400, 1401, 1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409,
1410, 1411, 1412, 1413, 1414, 1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422,
1424, 1425, 1427, 1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437,
1438, 1439, 1442, 1443, 1444, 1445, 1446, 1447, 1448, 1449, 601055, 701068,
701069, P0007130-0401002, P0007130-0401003, P0007130-0401004, P0007130-0401005,
P0007130-0401006, P0007130-0401007, P0007130-0401008, P0007130-0401009,
P0007130-0401010, P0007130-0401012, P0007130-0401013, P0007130-0401014,
P0007130-0401015, P0007130-0401016, P0007130-0401021, P0007130-0401031,
P0007130-0501056, and P0007130-0501075;
b) Serial Numbers: 1001, 1002, 1003,
1004, 1005, 1007, 1008, 1009, 1012, 1013, and 1014;
c) Serial Numbers: 1001,
1002, and 1003;
d) Serial Numbers: 1300, 1301, 1302, 1303, 1304, 1305, 1306,
1307, 1309, 1310, 1311, 1312, 1313, 1315, 1316, 1317, 1318, 1320, 1321, 1322,
1323, 1324, 1325, 1326, 1327, 1329, 1330, 1331, 1332, 1333, 1334, 1335, 1336,
1337, 1338, 1339, 1340, 1341, 1342, 1343, 1344, 1345, 1346, 1347, 1348, 1349,
1350, 1351, 1352, 1353, 1354, 1355, 1356, 1357, 1358, 1359, 1360, 1361, 1362,
1363, 1364, 1365, 1366, 1367, 1368, 1369, 1370, 1371, 1372, 1373, 1374, 1375,
1376, 1377, 1378, 1379, 1380, 1381, 1382, 1383, 1384, 1385, 1386, 1387, 1388,
1389, 1390, 1391, 1392, 1393, 1394, 1395, 1396, 1397, 1398, 1399, 1400, 1401,
1402, 1403, 1404, 1405, 1406, 1407, 1408, 1409, 1410, 1411, 1412, 1413, 1414,
1415, 1416, 1417, 1418, 1419, 1420, 1421, 1422, 1423, 1424, 1425, 1426, 1427,
1428, 1429, 1430, 1431, 1432, 1433, 1434, 1435, 1436, 1437, 1438, 1439, 1440,
1441, 1442, 1443, 1444, 1445, 1446, 1447, 1448, 1450, 1451, 1452, 1455, 1456,
1457, 1458, 1459, 1460, 1461, 1462, 1464, 1465, 1466, 1467, 401011, 401013,
401030, 601033, 701065, 701073, P0006939-0401004, P0006939-0401006,
P0006939-0401009, P0006939-0401015, P0006939-0401016, P0006939-0401017,
P0006939-0401026, and P0006939-0401034;
e) Serial Numbers: 401010, 401014,
P0006939-0401002, P0006939-0401007, P0006939-0401008, and
P0006939-0401012;
f) Serial Numbers: 1001, 1002, 1003, 1004, 1005, 1006,
1007, 1008, 1010, 1012, 1013, 1014, 1015, 1016, 1017, 1018, and 1019;
g)
Serial Numbers: 1322, 1323, 1324, 1325, 1326, 1327, 1328, 1329, 1330, 1331,
1332, 1333, 1334, 1335, 1336, 1337, 1338, 1339, 1340, 1341, 1342, 1343, 1344,
1345, 1346, 1348, 1349, 1350, 1352, 1353, 1354, 1355, 1356, 1357, 1359, 1360,
1362, 1363, 1364, 1365, and 1366
RECALLING
FIRM/MANUFACTURER Siemens Medical Solutions USA Inc., Knoxville, TN
REASON
Visual asymmetric appearance; An
asymmetry can be introduced into the attenuation-corrected PET images when using
iterative reconstruction in combination with a specific number of subsets and
reconstruction matrix sizes. (This problem only occurs when using protocols
other than the default Biograph protocols).
VOLUME OF PRODUCT IN
COMMERCE 414 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT
Abbott
Diagnostics CELL-DYN Sapphire Hemoglobin Reagent Analyzer Syringes, List Number
08H49-02, (the syringe is packaged in a white box and sealed with a label
wrapped around the center of the box-The main analyzer list number is 08H00-01,
),
CODE Package Dates (printed on
syringe label); 08 May 2007 to 25 June 2007
RECALLING
FIRM/MANUFACTURER Abbott Laboratories, Santa Clara, CA,
REASON
Syringe Failure. Insufficient lubrication
of the plunger tip may cause syringes to fail at installation or shortly
thereafter.
VOLUME OF PRODUCT IN COMMERCE 302
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
bioMerieux, BacT/ALERT® FA Culture Bottles,
CODE Lot Numbers: 1017685, 101793 and
1017788
RECALLING FIRM/MANUFACTURER bioMerieux, Inc.,
Durham, NC,
REASON Duplicate Bottle Indentification -- Three
lot numbers of BacT/ALERT® FA Culture Bottles labels contained duplicate bottle
identification (Bottle ID) barcode numbers. (Lots 1017685 and 1017788 contain
the same series of Bottle ID's; Lot 1017693 contains duplicate Bottle ID's
within the lot and may share Bottle ID's with both lots 1017685 and
1017788)
VOLUME OF PRODUCT IN COMMERCE 7,025
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
HAENG
LIM --Acupuncture Needles- PRE-STERILIZED GAMMA-RAY; 100 Packages (10
Needles/Package-1,000 needles in each box),
CODE All Lot Numbers and Serial
Numbers
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Marknew Products, Santa Fe Springs, CA,
Manufacturer: Haeng Lim Seo Won, Wonmiku Buchon, Korea, Republic Of
(South).
REASON Marketed without 510(k)
VOLUME OF
PRODUCT IN COMMERCE 320-380 boxes/100 packages (10
needles/package)
DISTRIBUTION Nationwide
PRODUCT Viasys
Healthcare NicoletOne ICU Monitor, Modular Neurodiagnostic System (containing
Axiomtek Panel PC computer system), released and installed between December 2004
and March 2007 (Axiomtek Panel PC Model Number: 2147-671) VIASYS NeuroCare Part
Numbers: 842-673800, 842-673900, 982A0421 and
982A0422,
CODE
ON040060, ON050120, ON050130, ON050168,
ON050186, ON050197, ON050199, ON050203, ON050206, ON050212, ON050220, ON050231,
ON060232, ON060243, ON060254, ON060256, ON060257, ON060269, ON060270, ON060272,
ON060275, ON060276, ON060277, ON060278, ON060279, ON060280, ON060288, ON060290,
ON060291, ON060292, ON060299, ON070301, ON070308
RECALLING
FIRM/MANUFACTURER Nicolet Biomedical Division of Viasys Healthcare,
Madison, WI
REASON Display lock-up: VIASYS Healthcare
NicoletOne ICU Monitor freezes up during operation when using the digital video
option.
VOLUME OF PRODUCT IN COMMERCE 33
units
DISTRIBUTION Nationwide and Internationally
WEEK ENDING JANUARY 19
PRODUCT
a) Siemens, ACUSON
Antares, Ultrasound System (Standard and Premium Edition), 5.0 Systems with software version 200.0.054, P/N:
10032747 and 10032746 standard, 10032746, 10037591, and
10038202 for premium edition,
b) Siemens, SONOLINE Antares Ultrasound System, 5.0 Systems with software version 200.0.054, P/N 05936518 and 10037593,
CODE
a) Serial numbers : 114792, 114819,
114822, 114827, 114829, 114839, 114843, 114844, 114845, 114846, 114847, 114848,
114849, 114851, 114859, 114860, 114861, 114863, 114864, 114871, 117874, 114876,
114880, 114881, 114882, 114885, 114890, 114891, 114894, 114895, 114909, 114910,
114912, 114918, 114921, 114927, 114928, 114930, 114931, 114935, 114941, 114944,
114947, 114948, 114949, 114953, 114957, 114958, 114959, 114960, 114962, 114963,
114971, 114977, 114978, 114730, 114735, 114745, 114761, 114781, 114785, 114826,
114865, 114868, 114869, 114896, 114936, 5000, 5001, 112919, 112925, 112971,
112980, 112981, 112984, 112989, 112992, 113005, 113009, 113013, 113015, 113037,
113040, 113041, 113042, 113045, 113048, 113051, 113052, 113053, 113055, 113058,
113061, 113067, 113068, 113075, 113076, 113079, 113080, 113101, 113102, 113105,
113143, 113145, 113147, 113204, 113225, 113257, 113259, 113302, 113407, 113411,
113414, 113462, 113469, 113566, 113682, 113706, 113715, 113759, 113767, 113803,
113825, 113826, 113827, 113828, 113829, 113831, 113832, 113834, 113835, 113841,
113843, 113846, 113847, 113848, 113849, 113850, 113851, 113852, 113856, 113863,
113873, 113900, 113917, 113921, 113945, 113947, 113950, 113957, 113980, 113986,
114014, 114043, 114052, 114061, 114164, 114172, 114176, 114186, 114233, 114254,
114255, 114271, 114274, 114313, 114351, 114356, 114363, 114406, 114461, 114474,
114475, 114481, 114482, 114493, 114536, 114573, 114583, 114584, 114590, 114596,
114587, 114602, 114612, 114614, 114616, 114617, 114621, 114640, 114644, 114647,
114652, 114655, 114661, 114665, 114669, 114671, 114675, 114687, 114690, 114694,
114699, 114703, 114706, 114716, 114721, 114728, 114734, 114732, 114740, 114742,
114743, 114744, 114749, 114751, 114753, 114754, 114755, 114757, 114759, 114760,
114762, 114764, 114768, 114770, 114771, 114773, 114775, 114777, 114782, 114789,
114790, 114791, 114792, 114793, 114794, 114796, 114799, 114802, 114805, 114807,
114808, 114809, 114810, 114811, 114813, 114818, 114819, 114820, 114821, 114822,
114825, 114827, 114828, 114829, 114831, 114833, 114834, 114835, 114836, 114838,
114842, 114843, 114844, 114844, 114845, 114846, 114847, 114848, 114849, 114850,
114851, 114853, 114857, 114859, 114860, 114861, 114863, 114864, 114866, 114870,
114873, 114878, 114886, 114899, 114901, 114908, 114914, 114916, 114920, 114926,
114937, 114939, 114940, 114943, 114945, 114950, 114955, 114973, 113322, 113904,
114228, 114415, 114524, 114528, 114566, 114568, 114623, 114630, 114632, 114635,
114636, 114645, 114646, 114651, 114672, 114685, 114717, 114723, 114724, 114725,
114726, 114727, 114729, 114733, 114736, 114737, 114739, 114741, 114746, 114747,
114748, 114750, 114752, 114758, 114769, 114765, 114766, 114767, 114779, 114780,
114783, 114784, 114786, 114788, 114795, 114797, 114798, 114800, 114801, 114803,
114804, 114806, 114812, 114814, 114816, 114823, 114824, 114830, 114832, 114837,
114840, 114841, 114852, 114854, 114855, 114858, 114862, 114867, 114868, 114869,
114872, 114875, 114877, 114879, 114887, 114888, 114889, 114892, 114893, 114897,
114898, 114900, 114902, 114903, 114904, 114905, 114907, 114911, 114913, 114915,
114919, 114922, 114923, 114924, 114925, 114929, 114933, 113249001, 113344001,
113458001, 113593001, 113731001, 113887001, and 113159001;
b) Serial Numbers:
111259, 111264, 111287, 111514, 112013, 112207, 111459, 112730, 113048, 113052,
113053, 113058, 113068, 113075, 113105, 113257, 113259, 113462, 113682, 113759,
113831, 113832, 113841, 113846, 113849, 113850, 113851, 113852, 113854, 113856,
113863, 113945, 113957, 114271, 114274, 114474, 114482, 114583, 114590, 114597,
114644, 114655, 114661, 114687, 114690, 114699, 114703, 114706, 114716, 114749,
114753, 114754, 114760, 114768, 114770, 114771, 114773, 114777, 114782, 114787,
114790, 111259, 111264, 111287, 111514, 111786, 112013, 112207, 111459, 112730,
111552001, 112697001, 10188001, 10566001, 10604001, 111249001, 111552001,
111901001, 111901002, 111994001, 112029001, 112083001, 112178001, 112182001,
112256001, 112306001, 112384001, 112407001, 112697001, 112713001, 112776001, and
113159001
RECALLING FIRM/MANUFACTURER Siemens Medical
Solutions USA, Inc., Mountain View, CA,
REASON Image errors: A
software problem results in on-screen indications (graphics) that lead the user
to believe that the patient's right and left and the transducer orientation are
oriented the same. This is not the case and the actual patient's right and left
are reversed from the on-screen indicators.
VOLUME OF PRODUCT IN
COMMERCE 418 units
DISTRIBUTION Nationwide
and
Internationally
PRODUCT ARCHITECT
i System Assay CD-ROM - WW (excluding USA accounts), Versions prior to Version
24.0; for use on the ARCHITECT i System; List Number (LN) 6E59,
CODE
LIst 6E59, Versions 22.0 and below,
Assay CD-ROM Lot Numbers: 34664P100, 34708P100, 49130P100, 49131P100, 50450P100,
54701P100, 50449P100, 52151P100, 54692P100
RECALLING
FIRM/MANUFACTURER Abbott Laboratories MPG, Abbott Park IL,
REASON
The lower limit flag for auto-dilution
protocol 3 (amniotic fluid) was set too low (15 ng/mL) for the ARCHITECT AFP
assay file for the ARCHITECT AFP non-U.S. product. The assay labeling indicates
that the limit flag should be set no lower than 20 ng/mL
VOLUME OF
PRODUCT IN COMMERCE 2,490
units
DISTRIBUTION Internationally
PRODUCT Ventana Medical System's Symphony Staining System,
KPA, Model #:
2200000, Catalog #: 900-SYM1 & 900-SYM3,
CODE Serial Numbers: 910006-910011,
910013-910016, 910019, 910020, 910022, 910023, 910029, 910031-910033, 910036,
910049, 910053, 910054, 910056, 910057, and 910060
RECALLING
FIRM/MANUFACTURER Ventana Medical Systems Inc, Tucson, AZ,
REASON Devices released prior to full testing; during
internal testing it was discovered that the configuration of the Symphony
instrument during Hi pot testing procedures does not completely evaluate all
components in the test loop.
VOLUME OF PRODUCT IN
COMMERCE 45 units
DISTRIBUTION Nationwide and
Internationally
PRODUCT Toshiba
Aplio XG Diagnostic Ultrasound System, Model: SSA-790A with version 1.1
software,
CODE
Serial Numbers:
99B0752571, 99B0752572, 99B06Z2073, 99B06Z2102, 99B06Z2107, 99B0722268,
99B0722269, 99B0722270, 99B0722271, 99B0722272, 99B0732349, 99B0732350,
99B0732351, 99B0732352, 99B0732353, 99B0732354, 99B0722208, 99B0722250,
99B0752531, 99B0752532, 99B06Z2072, 99B0752508, 99B0752509, 99B0752510,
99B0752511, 99B0722251, 99B06Z2071, 99B0722206, 99B0722207, 99B0722204,
99B0752524, 99B0752525, 99B0732355, 99B0742413, 99B0742414, 99B0742415,
99B0742416, 99B0742417, 99B0722203, 99B06Z2062, 99B0722201, 99B0712171,
99B0722254, 99B0752507, 99B06Z2064, 99B06Z2104, 99B0712169, 99B0712172,
99B0722202, 99B0752570, 99B0752562, 99B0752563, 99B0752564, 99B0752565,
99B06Z2103, 99B0752523, 99B0752550, 99B06Z2074, 99B0712173, 99B0712174,
99B06Z2059, 99B0752551, 99B0752561, 99B06Z2108, 99B0752549, 99B0722205,
99B0752547, 99B0712168, 99B0722253, 99B06Y2048, 99B06Y2049, 99B06Y2051,
99B06Z2058, 99B06Z2067, 99B06Z2110, 99B06Z2116, 99B06Z2057, 99B06Z2088,
99B06Z2105, 99B06Z2111, 99B06Z2115, 99B0722252, 99B06Z2063, 99B06Z2065,
99B06Z2066, 99B06Z2090, 99B06Z2101, 99B06Z2113, 99B0712170, 99B06Z2060,
99B06Z2068, 99B06Z2070, 99B06Z2106, 99B0752548, 99B06Z2089, 99B06Z2091,
99B06Z2092, 99B06Y2050, 99B06Z2055, 99B06Z2056, 99B06Z2061, 99B06Z2069,
99B06Z2075, 99B06Z2109, 99B06Z2112, and 99B06Z2114
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Toshiba American Med Sys Inc.,
Tustin, CA,
Manufacturer: Toshiba
Corp. Medical Engineering Ctr., Nasu Works, Tochigi, Japan.
REASON
Panel Lock-up: When using
dynamic image acquisition modes the panel may lock up, if the operator attempts
to perform a still image capture. If the panel locks up the system will have to
be rebooted to continue the examination which may cause a delay in completion of
the patient examination.
VOLUME OF PRODUCT IN COMMERCE 69
units
DISTRIBUTION Nationwide
PRODUCT
a)
VariLift Bone Plug w/ End Cap; 14mm Dia, 24mm long; Ref #: CEA1-14-24-BP; Sterile,
b) VariLift Bone
Plug w/ End Cap; 16mm Dia, 24mm long; Ref #: CEA1-16-24-BP; Sterile,
c) VariLift Bone
Plug w/ End Cap; 18mm Dia, 24mm long; Ref #: CEA1-18-24-BP; Sterile,
d) VariLift Bone
Plug w/ End Cap; 11mm Dia, 24mm long; Ref #: CIE1-11-24-BP; Sterile,
e) VariLift Bone Plug
w/ End Cap; 13mm Dia, 24mm long; Ref #: CIE1-13-24-BP;
Sterile,
f) VariLift Bone Plug w/ End Cap; 15mm Dia,
24mm long; Ref #: CIE1-15-24-BP; Sterile,
CODE
a) Lot #: U101;
b) Lot #:
U102;
c) Lot #: U103 and U171;
d) Lot #: 122CIE1-11-24-BP, 2245, 2250,
2260, 2535, 2545, 2940, U051, U748 and W657;
e) Lot #:
2945, Y299, Y301, 2235, 2240, 2565, 1.0186C and 1.0278B;
f) Lot #:
122CIE1-15-24-BP, 291C, T179, T184, T412, T416, T425, 2950, 53845879, 53852082, X117 and X118
RECALLING
FIRM/MANUFACTURER Encore Medical Lp, Austin, TX,
REASON
Device marketed without label warning
required in the device's 510(k) approval letter. (In part-Warning: This device
is not intended for any spinal indications.....)
VOLUME OF PRODUCT IN
COMMERCE 175
units
DISTRIBUTION Nationwide
PRODUCT
Transilluminator,
Model BFO-150, a Fiber Optic Light Source (Illuminator), available in 2
voltages: 115v for USA users & 220v for foreign countries,
CODE
All Serial Numbers on the
market
RECALLING FIRM/MANUFACTURER Chiu Technical Corp.,
Kings Park, NY
REASON Device was marketed without a
510(k).
VOLUME OF PRODUCT IN COMMERCE 191
units
DISTRIBUTION Nationwide, Canada and
India
PRODUCT
a)
Dale 240 Blue (Adults) Trachestomy Tube Holder, Product Number: H84102401,
b) Dale 242 Blue (Neonate,
Infants and Small Children) Trachestomy Tube Holder,
Product Number: H84102421,
CODE All
lots
RECALLING FIRM/MANUFACTURER Dale Medical Products,
Inc., Plainville, MA
REASON Revised Labeling: Instructions For
use: "Do not trim fastener hook tabs." Trimming can cause tabs to disengage at
the trach plate.
VOLUME OF PRODUCT IN COMMERCE 665,000
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
1)
Disposable Angled MVR Blade (23 gauge/0.6mm), REF/Item Code: 1282D0.6,
2) PremierEdge, MICROSURGICAL
KNIFE, 1.2mm, Sideport Knife, REF/Item Code: PE 3012,
3) PremierEdge, Bulk Microsurgical Knife. 1.2mm,
Sideport Knife, Item Code B- PE3012,
4) PremierEdge, Bulk Microsurgical Knife, 3.0mm Slit Knife, Item
Code B-PE3830,
5) Eyemaxx your
choice!, Microsurgical Knife 3.0mm Slit Knife, REF/Item Code: MX2030, MADE IN USA,
6)
PremierEdge, MICROSURGICAL KNIFE,15 DEGREES STAB KNIFE, REF/Item Code: PE 3015,
7)
PremierEdge,
MICROSURGICAL KNIFE, 30 DEGREES STAB KNIFE, REF/item
Code: PE 3030,
8) PremierEdge MICROSURGICAL KNIFE, 45
DEGREES STAB KNIFE, REF/Item Code: PE 3045,
9) PremierEdge MICROSURGICAL KNIFE, 2.5mm Clear Cornea Knife,
REF/Item Code: PE 3125;
10) PremierEdge MICROSURGICAL KNIFE, 2.85mm Clear Cornea Knife,
Item Code/ REF: PE 3128,
11) PremierEdge MICROSURGICAL KNIFE, 3.0mm Clear Cornea Knife,
Item Code/REF: PE 3130;
12) PremierEdge MICROSURGICAL KNIFE, 3.2mm Clear Cornea Knife,
Item Code/REF: PE 3132;
13) PremierEdge MICROSURGICAL KNIFE, 2.65mm Clear Cornea Knife -
Parallel Sides, Item Code/REF: PE 3226;
14) PremierEdge MICROSURGICAL KNIFE, 2.85mm
Clear Cornea Knife - Parallel Sides, Item
Code/REF: PE 3228,
15) PremierEdge MICROSURGICAL KNIFE,
3.0mm Clear Cornea Knife - Parallel Sides,
Item Code/REF: PE 3230,
16) PremierEdge MICROSURGICAL
KNIFE, 2.5-3.0mm Clear Cornea Knife –
Trapezoid, Item Code/REF: PE 3302,
17) PremierEdge
MICROSURGICAL KNIFE, 3.2mm Implant Knife, Item Code/REF: PE 3432,
18)
PremierEdge MICROSURGICAL KNIFE, 3.5mm Implant Knife, Item Code/REF: PE 3435,
19)
PremierEdge MICROSURGICAL KNIFE ,4.0mm Implant Knife, Item Code/REF: PE 3440;
20)
PremierEdge MICROSURGICAL KNIFE, 23g MVR Knife, Item Code/REF: PE3523,
21)
PremierEdge MICROSURGICAL KNIFE, 3.0mm Round, Tunnel Knife, Item Code/REF: PE 3630,
22) PremierEdge MICROSURGICAL KNIFE, 2.0mm Angled Crescent
Tunnel Knife, Angled, Item Code/REF: PE
3720A;
23) PremierEdge MICROSURGICAL KNIFE, 2.65mm Slit
Knife, Item Code/REF: PE 3826;
24) PremierEdge MICROSURGICAL KNIFE, 2.75mm Slit Knife, Item
Code/REF: PE 3827;
25) PremierEdge MICROSURGICAL KNIFE, 2.85mm Slit Knife, Item
Code/REF: PE 3828;
26) PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife, Item
Code/REF: PE 3830;
27) PremierEdge MICROSURGICAL KNIFE, 3.0mm Slit Knife - Straight
Item Code/REF: PE 3830S;
28) PremierEdge MICROSURGICAL KNIFE, 3.2mm Slit Knife; Item
Code/REF: PE 3832;
29) PremierEdge MICROSURGICAL KNIFE, 2.4mm Thin Slit Knife, Item
Code/REF: PE 4824-TL;
30) PremierEdge MICROSURGICAL KNIFE, 2.75mm Thin Slit Knife,
Item Code/REF: PE4827-TL;
31) PremierEdge MICROSURGICAL KNIFE , 2.85mm Thin Slit Knife,
Item Code/REF: PE4828-TL;
32) PremierEdge MICROSURGICAL KNIFE, 3.0mm Thin Slit Knife, Item
Code/REF: PE4830-TL;
CODE
1) Lot No: DK1106H, DK0107L,
DK0407G, and DK0407O;
2) Lot No.: DK0407A, and DK0407B;
3)
Lot No.: DK0207Q, DK0307I, DK0407M, DK0507R;
4) Lot No:
DK0407H;
5) Lot No.: DK1206U;
6) Lot No.: DK1106M, DK1106T,
and DK0207R;
7) Lot No: DK0207S;
8) Lot No: DK0207T,
DK0307M, and DK0507A;
9) Lot No: DK1106X;
10) Lot
No: DK0207V and DK0307N;
11) Lot No: DK1106Z and DK0107Q;
12) Lot No:
DK0107R;
13) Lot No: DK0107S, DK0207X, DK0307A and DK0107AG;
14) Lot No:
DK0307O and DK0407K;
15) Lot No: DK0207AA;
16) Lot No: DK0307AJ;
17)
Lot No: DK0107U and DK0207AB;
18) Lot No: DK0107V, DK0207E and
DK0507V;
19) Lot No: DK0307B and DK0407C;
20) Lot No: DK0307AH;
21) Lot
No: DK1106P and DK0207AC;
22) Lot No: DK0107AA, DK0207H, DK0207AD and
DK0307E;
23) Lot No: DK1106I, DK0107AB, and DK0107AK;
24) Lot No: DK1106N,
DK1106AG, DK0207AF and DK0307T;
25) Lot No: DK0107AC, DK0207K, DK0207AG,
DK0307G, DK0307U, and DK0507AD;
26) Lot
No: DK1106J, DK0207M, DK0207AH, DK0307H, DK0407L, and DK0507E;
27) Lot Code:
DK0107AD and DK0207N;
28) Lot No: DK1106Q;
29) Lot No: DK0307AI;
30)
Lot Code: DK0507G and DK0507AE;
31) Lot Code: DK0407D;
32) Lot No:
DK0407E
RECALLING FIRM/MANUFACTURER Oasis Medical Inc,
Glendora, CA,
REASON Sterility (package integrity)
compromised: the device is puncturing the packing during handling. Once the
packaging is damaged, the product is no longer sterile as labeled. THIS IS AN
EXPANSION OF A PREVIOUS RECALL.
VOLUME OF PRODUCT IN
COMMERCE 28,319 individual
knives
DISTRIBUTION Nationwide and Internationally
PRODUCT
a) Extron
Electronics OEM, CAB, DVI-Male to DVI-Female Cable Assembly (14 inch.); Part #: 43-111-01
(Stryker Part #:0100-224-131); (These
cables are commonly used with the Switchpoint Infinity
II),
b) Extron Electronics OEM, CAB, DVI-I to DVI
(3ft.); Part #: 43-112-01 (Stryker Part #: 0100-224-108);
(These cables are commonly used with the Switchpoint
Infinity II),
CODE All Lots
and Serial Numbers shipped between Oct. 2006 and June 2007
RECALLING
FIRM/MANUFACTURER
Recalling Firm: Stryker Communications, Flower
Mound, TX,
Manufacturer: Extron
Electronics, Anaheim, Ca.
REASON Intermitten or Complete Loss of Signal:
out-of-specification DVI cables causing intermitten or complete loss of signal
on monitors used in surgery.
VOLUME OF PRODUCT IN
COMMERCE 3,908 cables
DISTRIBUTION Nationwide
and Internationally
PRODUCT Cepheid, Xpert GBS Assay Diagnostic Test Kit Part No: GXGBS-100N-10
(in foil pouch) for use with the GeneXpert DX System,
CODE
Lot Number: 1402
RECALLING
FIRM/MANUFACTURER Cepheid, Sunnyvale, CA,
REASON
Labeling Error: Some cartridges may be
mislabeled as "Xpert EV" instead of "Xpert GBS". (The information embedded in
the barcode label on the cartridge is correct for Xpert GBS and brings up the
GBS assay definition file).
VOLUME OF PRODUCT IN
COMMERCE 105 units
DISTRIBUTION Nationwide
and Internationally
AM2 PAT, Inc. Issues Recall of All Lots and All Sizes of Pre-Filled Heparin and Normal Saline Flushes
AM2 PAT, Inc., Angier, North Carolina, is issuing a nationwide recall of all lots of both Heparin and Saline pre-filled flushes manufactured by AM2 PAT. These products are distributed under two brand names, Sierra Pre-Filled Inc. and B. Braun. These products are sold in 3ml, 5ml sizes for Heparin and 3ml, 5ml and 10ml sizes for Normal Saline. Both products are sold as pre-filled syringes.
One lot under recall of this product 1003-02, Lot 070926H, heparin IV flush syringes has been found to be contaminated with Serratia marcescens, which has resulted in patient infections.
This type of bacterial infection could present a serious adverse health consequence that could lead to life-threatening injuries and/or death.
Consumers and user facilities who have any of these recalled pre-filled syringes, Heparin or Saline Lock Flush Solution USP, should stop using the product immediately. These products should be immediately quarantined in your inventory and returned to your distributor immediately.
The following information for this recall includes:
MANUFACTURER: Sierra Pre-Filled, Inc., Angier, North Carolina
PRODUCT DESCRIPTION: Heparin Lock Flush Solution USP, All Strengths and Sizes
Saline Lock Flush Solution USP, All Strengths and Sizes
|
LOT # |
NDC # |
CATALOG # |
Product Brand Name |
|
All |
64054-1003-02 |
1003-02 |
Heparin Lock Flush 100units/ml 5ml |
|
|
64054-1003-01 |
1003-01 |
Heparin Lock Flush 100units/ml 3ml |
|
|
64054-3005-02 |
3005-02 |
Heparin Lock Flush 10units/ml 5ml |
|
|
64054-3003-02 |
3003-02 |
Heparin Lock Flush 10units/ml 3ml |
|
|
64054-3003-06 |
3003-06 |
Heparin Lock Flush 10units/mL 3ml (6ml syringe) |
|
|
64054-3005-06 |
3005-06 |
Heparin Lock Flush 10units/mL 5ml (6ml syringe) |
|
|
64054-0910-2 |
0910-12 |
Normal Saline Flush 10ml |
|
|
64054-0905-2 |
0905-12 |
Normal Saline Flush 5ml |
|
|
64054-0903-2 |
0903-12 |
Normal Saline Flush 3ml |
The firm recalled these products after confirming bacterial contamination in some end user samples of product code 1003-02, Lot 070926H.
These products have been distributed nationwide.
Consumers with questions may contact Sierra Pre-Filled at 919-552-9689, Monday through Friday, 10am-5pm Eastern Standard Time.
B. Braun's Supplier Prompts Recall of All Lots and All Sizes of
Pre-Filled Heparin and Normal Saline Flush Syringes
AM2PAT Inc. manufactures these pre-filled syringes under both its
private label, Sierra Pre-Filled Inc., as well as under the B. Braun Medical
Inc. label
B. Braun Medical Inc. was recently notified by its contract manufacturer, AM2PAT Inc., of a nationwide recall of all lots and sizes of Pre-filled Heparin and Saline Flush Syringes.
|
Catalog # |
Lot # |
Description |
|---|---|---|
|
513584 |
All |
Normal Saline 3mL in 12 mL Syringe |
|
513586 |
All |
Normal Saline 5mL in 12 mL Syringe |
|
513587 |
All |
Normal Saline 10mL in 12 mL Syringe |
|
513610 |
All |
10 units/mL Heparin, 5mL in 12 mL Syringe |
|
513611 |
All |
100 units/mL Heparin, 3mL in 12 mL Syringe |
|
513612 |
All |
100 units/mL Heparin, 5mL in 12 mL Syringe |
Customers that have the recalled product in their possession should discontinue use immediately. If patients report any problems that may be related to usage of this product a physician should be contacted. Customers may contact the B. Braun Medical Inc.
Customer Support Department at (800) 227-2862, Monday through Friday, 8 AM to 7 PM EST for instructions for handling the affected product and to arrange for replacement product.
WEEK ENDING JANUARY 26
PRODUCT Datascope,
Panorama Patient Monitoring Network; Panorma Telepack 608; Software Versions
8.1.X, 8.3, 8.3.1, 8.4.1, and 8.5.X, Part Number: 0998-00-0191-04,
CODE
Part Number:
0998-00-0191-04
RECALLING FIRM/MANUFACTURER Datascope
Corporation, Fairfieldm, NJ,
REASON Display problems: If an ECG
cable, which has been damaged due to the ingress of liquid or by mechanical
trauma, is utilized with the Telepack, it may cause the Telepack to switch
between the 3-lead and 5 lead-input modes. During the switching process, the
digital heart rate displayed at the Panorama Central Station will be frozen, and
subsquent arrthymia alarms will not be announced.
VOLUME OF PRODUCT
IN COMMERCE 338
sites
DISTRIBUTION Nationwide
PRODUCT
a)
Actiwatch 16 Part Number 198-0300-00, Actiwatch 16 AM 198-0300-AM;
Actiwatch 64 Part Number 198-0301-00; Actiwatch 64 AM
Part Number
198-0301-AM,
b)
Actical with Step, Part Number 198-0302-00, Recall # Z-0325-2008;
c)
Actiwatch 64 AM, Bandless Part Number 198-0301-AM1, Recall # Z-0326-2008;
d)
Actiwatch 16, Basic Startup pkg 198-1010-00; and Actiwatch 64, Basic Startup
pkg Part Number 198-1000-00,
CODE
a) Serial Numbers: V960641, V960642,
V960655, V960656, V960657, V960658, V960660, V960661, V960986, V961113, V961114,
V961115, V961116, V961117, V961118, V961119, V961120, V961177, V961178, V961179,
V961180, V961181, V961182, V961183, V961184, V961185, V961186, V961187, V961188,
V961189, V961191, V961192, V961193, V961194, V961195, V961196, V961197, V961198,
V961199, V961200, V961513, V961514, V961515, V961516, V961517, V961518, V961519,
V961520, V961593, V961594, V961595, V961596, V961597, V961598, V961599, V961600,
V961601, V961602, V961603, V961604, V961605, V961606, V961607, V961608, V961609,
V961610, V961611, V961612, V961613, V961614, V961615, V961616, V961617, V961121,
V961122, V961123, V961124, V961125, V961126, V961127, V961128, V961321, V961322,
V961323, V961324, V961325, V961326, V961327, V961328, V961329, V961330, V961331,
V961332, V961333, V961334, V961335, V961336, V961337, V961338, V961339,
V961340,V960611, V960617, V960618, V960619, V960620, V960621, V960622, V960629,
V960630, V960631, V960632, V960635, V960638, V960639, V960640, V960643, V960644,
V960645, V960663, V960669, V960671, V960673, V960678, V960681, V960682, V960684,
V960685, V960686, V960689, V960690, V960692, V960693, V960694, V960695, V960696,
V960697, V960698, V960701, V960702, V960709, V960710, V960720, V960721, V960722,
V960723, V960724, V960725, V960726, V960728, V960729, V960730, V960731, V960732,
V960736, V960737, V960742, V960743, V960744, V960745, V960746, V960747, V960748,
V960749, V960751, V960752, V960753, V960754, V960755, V960757, V960758, V960760,
V960761, V960834, V960835, V960836, V960837, V960838, V960839, V960840, V960841,
V960842, V960843, V960844, V960845, V960846, V960847, V960848, V960849, V960850,
V960851, V960854, V960855, V960856, V960857, V960858, V960859, V960860, V960861,
V960862, V960863, V960871, V960872, V960875, V960876, V960877, V960878, V960879,
V960882, V960889, V960891, V960892, V960893, V960894, V960895, V960896, V960897,
V960898, V960900, V960902, V960903, V960904, V960913, V960914, V960915, V960916,
V960917, V960918, V960919, V960920, V960921, V960922, V960923, V960924, V960925,
V960928, V960929, V960930, V960931, V960932, V960933, V960934, V960935, V960936,
V960937, V960938, V960939, V960940, V960941, V960942, V960943, V960944, V960945,
V960946, V960947, V960948, V960949, V960950, V960951, V960952, V960953, V960954,
V960955, V960956, V960957, V960958, V960959, V960960, V960961, V960962, V960963,
V960964, V960965, V960966, V960967, V960968, V960969, V960970, V960971, V960972,
V960973, V960974, V960975, V960976, V960977, V960978, V960979, V960980, V960981,
V960982, V960983, V960984, V960993, V961009, V961016, V961017, V961018, V961021,
V961023, V961024, V961025, V961026, V961027, V961028, V961029, V961030, V961032,
V961034, V961035, V961036, V961038, V961039, V961040, V961042, V961043, V961044,
V961045, V961047, V961048, V961049, V961050, V961051, V961052, V961053, V961054,
V961056, V961057, V961058, V961059, V961060, V961064, V961066, V961067, V961068,
V961130, V961134, V961144, V961145, V961146, V961147, V961148, V961149, V961150,
V961151, V961152, V961201, V961202, V961203, V961204, V961205, V961206, V961207,
V961208, V961209, V961210, V961211, V961212, V961213, V961214, V961215, V961216,
V961260, V961278, V961283, V961320, V961348, V961351, V961352, V961353, V961354,
V961355, V961356, V961357, V961358, V961360, V961367, V961368, V961369, V961370,
V961371, V961372, V961373, V961374, V961375, V961376, V961377, V961378, V961379,
V961381, V961382, V961383, V961388, V961389, V961390, V961391, V961392, V961393,
V961394, V961396, V961397, V961398, V961399, V961400, V961401, V961402, V961403,
V961404, V961405, V961406, V961407, V961408, V961409, V961410, V961411, V961412,
V961413, V961414, V961415, V961416, V961417, V961418, V961419, V961420, V961421,
V961422, V961423, V961424, V961425, V961426, V961427, V961428, V961429, V961430,
V961431, V961432, V961433, V961434, V961435, V961436, V961437, V961438, V961439,
V961440, V961442, V961444, V961445, V961446, V961447, V961448, V961449, V961450,
V961451, V961452, V961453, V961454, V961455, V961456, V961457, V961458, V961459,
V961460, V961461, V961462, V961463, V961464, V961465, V961466, V961467, V961468,
V961469, V961470, V961471, V961472, V961473, V961474, V961475, V961476, V961477,
V961478, V961479, V961480, V961481, V961485, V961486, V961487, V961488, V961510,
V961511, V961512, V961521, V961522, V961523, V961524, V961525, V961526, V961529,
V961530, V961531, V961532, V961534, V961535, V961536, V961538, V961539, V961540,
V961542, V961543, V961544, V961545, V961546, V961547, V961548, V961549, V961550,
V961551, V961552, V961553, V961554, V961555, V961556, V961561, V961591, V961592,
V961625, V961626, V961627, V961628, V961629, V961630, V961631, V961632, V961633,
V961634, V961635, V961636, V961637, V961638, V961639, V961640, V961641, V961642,
V961643, V961644, V961645, V961647, V961648, V961649, V961650, V961652, V961653,
V961654, V961655, V961656, V961689, V961690, V961691, V961692, V961693, V961694,
V961695, V961696, V961697, V961698, V961699, V961700, V961701, V961702, V961703,
V961704, V961705, V961706, V961707, V961708, V961713, V961714, V961715, V961716,
V961717, V961718, V961727, V961728, V961729, V961730, V961731, V961732, V961733,
V961735, V961736, V961737, V961738, V961739, V961740, V961741, V961742, V961896,
V961897, V961900, V961901, V961902, V961903, V961904, V961905, V961906, V961907,
V961908, V961909, V961910, V961569, V961570, V961571, V961572, V961573, V961574,
V961575, V961576, V961752, V961753, V961754, V961755, V961756, V961757, V961758,
V961759, V961760, V961761, V961762, V961763, V961764, V961765, V961766, V961768,
V961769, V961770, V961771, and V961772;
b) Serial Numbers: B100001,
B100002, B100003, B100005, B100006, B100007, B100008, B100009, B100023, B100024,
B100025, B100026, B100027, B100028, B100029, B100030, B100031, B100032, B100033,
B100034, B100035, B100036, B100037, B100038, B100039, B100041, B100042, B100043,
B100044, B100045, B100046, B100047, B100048, B100049, B100050, B100051, B100052,
B100053, B100054, B100055, B100056, B100057, B100058, B100059, B100060, B100061,
B100062, B100063, B100064, B100065, B100066, B100067, B100068, B100069, B100070,
B100071, B100072, B100073, B100074, B100075, B100076, B100077, B100078, B100079,
B100080, B100081, B100082, B100083, B100084, B100085, B100086, B100087, B100088,
B100089, B100090, B100091, B100092, B100093, B100094, B100095, B100096, B100097,
B100098, B100099, B100100, B100101, B100102, B100103, B100104, B100105, B100106,
B100107, B100108, B100109, B100110, B100111, B100112, B100113, B100114, B100115,
B100116, B100117, B100118, B100119, B100120, B100121, B100122, B100123, B100124,
B100125, B100126, B100127, B100128, B100129, B100130, B100131, B100132, B100133,
B100134, B100135, B100136, B100137, B100138, B100139, B100140, B100141, B100142,
B100143, B100144, B100145, B100146, B100147, B100148, B100149, B100150, B100151,
B100152, B100153, B100154, B100155, B100156, B100157, B100158, B100159, B100160,
B100161, B100162, B100163, B100164, B100165, B100166, B100167, B100168, B100169,
B100170, B100171, B100172, B100173, B100174, B100175, B100176, B100177, B100178,
B100179, B100180, B100181, B100182, B100183, B100184, B100185, B100186, B100187,
B100188, B100189, B100190, B100191, B100192, B100193, B100194, B100195, B100196,
B100197, B100198, B100199, B100200, B100201, B100202, B100203, B100204, B100205,
B100206, B100207, B100208, B100209, B100210, B100211, B100212, B100213, B100214,
B100215, B100216, B100217, B100218, B100219, B100220, B100221, B100222, B100223,
B100224, B100225, B100226, B100227, B100228, B100229, B100230, B100231, B100232,
B100233, B100234, B100235, B100236, B100237, B100238, B100239, B100240, B100241,
B100242, B100243, B100244, B100245, B100246, B100247, B100248, B100249, B100250,
B100251, B100252, B100253, B100254, B100255, B100256, B100257, B100258, B100259,
B100260, B100261, B100262, B100263, B100264, B100265, B100266, B100267, B100268,
B100269, B100270, B100271, B100272, B100273, B100274, B100275, B100276, B100277,
B100278, B100279, B100280, B100281, B100282, B100283, B100284, B100285, B100286,
B100287, B100288, B100289, B100290, B100291, B100292, B100293, B100294, B100295,
B100296, B100297, B100298, B100299, B100300, B100301, B100302, B100303, B100304,
B100305, B100306, B100307, B100308, B100309, B100310, B100311, B100312, B100313,
B100314, B100315, B100316, B100317, B100318, B100319, B100320, B100321, B100322,
B100323, B100324, B100325, B100326, B100327, B100328, B100329, B100330, B100331,
B100332, B100333, B100334, B100335, B100336, B100337, B100338, B100339, B100340,
B100341, B100342, B100343, B100344, B100345, B100346, B100347, B100348, B100349,
B100350, B100351, B100352, B100353, B100354, B100355, B100356, B100357, B100358,
B100359, B100360, B100361, B100362, B100363, B100364, B100365, B100366, B100367,
B100368, B100369, B100370, B100371, B100372, B100373, B100374, B100375, B100376,
B100377, B100378, B100379, B100380, B100381, B100382, B100383, B100384, B100385,
B100386, B100387, B100388, B100389, B100390, B100391, B100392, B100393, B100394,
B100395, B100396, B100397, B100398, B100399, B100400, B100401, B100402, B100403,
B100406, B100407, B100408, B100409, B100410, B100411, B100412, B100413, B100414,
B100415, B100416, B100417, B100418, B100419, and B100420;
c) Serial
Numbers: V960132, V960133, V960135, V960191, V960253, V960254, V960255, V960256,
V960257, V960314, V960460, V960461, V960469, V960481, V960483, V960487, V960488,
V960504, V960505, and V960550;
d) Serial Numbers: V960700, V960703,
V960735, V960739, V960740, V960864, V960865, V960866,
V960868, V960869, V960870, V961013, V961014, V961015,
and V960659
RECALLING
FIRM/MANUFACTURER Mini-Mitter Company, Inc., Bend, OR,
REASON
Communication Failure: the devices have a
memory chip that has a limited number of read/write cycles which can trigger set
up information and/or subject information anomalies or intermittent
communication annomalies. If left unaddressed, the issues can lead to permanent
communication failure.
VOLUME OF PRODUCT IN
COMMERCE 1,073 units
DISTRIBUTION Nationwide
and Internationally
PRODUCT SERFAS Energy Suction Probe, Model 279-351-100, 3.5mm 90-S,
CODE
Lot Numbers: 06361AE2 06362AE2
07004AE2 07008AE2 07010AE2 07012AE2 07016AE2 07017AE2 07018AE2 07022AE2 07025AE2
07026AE2 07029AE2 07031AE2 07036AE2 07038AE2 07043AE2, and
07044AE2
RECALLING FIRM/MANUFACTURER
Recalling Firm:
Stryker Endoscopy, San Jose, CA,
Manufacturer: Stryker Puerto Rico, Inc., Arroyo, PR.
REASON
Device Shut off/on:
Device may not turn off after taking finger/foot off of activating switch and
may activate without pushing a button. (Patient burns may result from these
device malfunctions)
VOLUME OF PRODUCT IN COMMERCE 6,037
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT GE
Medical Systems Information Technologies Clinical Information Center (CIC) Pro
v5.0.3 & v5.0.6 systems, GE Healthcare, Clinical Systems,
CODE
JA104480715GA JA104521071GA
JA106405918GA JA106405954GA JA106426089GA JA106426106GA JA104290048GA
JA104389244GA JA104480664GA JA104480715GA JA105111564GA JA105121632GA
JA105151746GA JA105151749GA JA105171811GA JA105342546GA JA1054833330GA
JA105493389GA JA105493412GA JA1060043963GA JA10606491GA JA106074297GA
JA106134601GA JA1061446747GA JA106164772GA JA106245153GA JA106295351GA
JA106355517GA JA106365600GA JA106426063GA JA106426100GA JA106486211GA
JA106486215GA JA107096739GA JA107096742GA JAI06345514GA SCH06430010GA
SCH06440050GA SCH06440062GA SCH06460310GA SCH06470347GA SCH06470350GA
SCH06510406GA SCH07040470GA SCH07050547GA SCH0706057GA SCH07070604GA
SCH07070653GA SCH07080669GA. SCH07080671GA SCH07080699GA SCH07080709GA
SCH07080731GA SCH07120796GA SCH07120809GA SCH07120825GA SCH07130839GA
SCH07130865GA SCH07130882GA SCH07140933GA SCH07150953GA SCH07150963GA
SCH07161062GA SCH07181099GA SCH07191148GA SCH07191156GA. SCH07201187GA
SCH07201190GA SCH07211226GA SCH07231266GA SCH07231276GA SCH07231291GA
SCH07231303GA SCH07261336GA SCH07261339GA SCH07261351GA SCH07261354GA
SCH07301566GA SCH073115892GA SCH07321745GA SCH07331762GA SCH07331774GA
SCH07331792GA SCH07331810GA SCH07331811GA SCH07361897GA SCH07361902GA
SCH07361911GA SCH07361931GA SCH07361956GA SCH07362006GA SCH07382330GA
SCH07080714GA SCH07392353GA SCH07161009GA JA104380193GA SCH06240003GA
SCH06430007GA SCH06430009GA SCH06430030GA SCH06430035GA SCH06430036GA
SCH06430039GA SCH06430041GA SCH06430045GA SCH06430048GA SCH06440049GA
SCH06440051GA SCH06440052GA SCH06440053GA SCH06440056GA SCH06440058GA
SCH06440060GA SCH06440063GA SCH06440064GA SCH06440065GA SCH06440067GA
SCH06440069GA SCH06440072GA SCH06440076GA SCH06440077GA SCH06440080GA
SCH06440082GA SCH06440083GA SCH06440084GA SCH06440094GA SCH06440117GA
SCH06440119GA SCH06440121GA SCH06440122GA SCH06440123GA SCH06440126GA
SCH06440128GA SCH06440136GA SCH06440144GA SCH06440151GA SCH06440155GA
SCH06440161GA SCH06440175GA SCH06440184GA SCH06440185GA SCH06440187GA
SCH06440190GA SCH06440202GA SCH06450208GA SCH06450209GA SCH06450210GA
SCH06450214GA SCH06450215GA SCH06450217GA SCH06450219GA SCH06450223GA
SCH06450227GA SCH06450232GA SCH06470352GA SCH06510388GA SCH06510389GA
SCH06510390GA SCH06510391GA SCH06510398GA SCH06510409GA SCH06510410GA
SCH06510412GA SCH06510414GA SCH06510417GA SCH06510418GA SCH06510419GA
SCH06510421GA SCH06510426GA SCH06510427GA SCH06510428GA SCH06510429GA
SCH06510430GA SCH06510431GA SCH07040496GA SCH07050506GA SCH07050520GA
SCH07050556GA SCH07060590GA SCH07070610GA SCH07070626GA SCH07110764GA
SCH07110777GA SCH07120806GA SCH07120830GA SCH07140890GA SCH07140894GA
SCH07140904GA SCH07140906GA SCH07140912GA SCH07140922GA SCH07140936GA
SCH07140938GA SCH07140942GA SCH07150948GA SCH07150960GA SCH07150994GA
SCH07151000GA SCH07151003GA SCH07151006GA SCH07161019GA SCH07161025GA
SCH07161054GA SCH07161062GA SCH07161063GA SCH07221233GA SCH07221244GA
SCH07261343GA SCH07291492GA SCH07291511GA SCH07291513GA SCH07301516GA
SCH07301519GA SCH07301522GA SCH07301523GA SCH07301524GA SCH07301525GA
SCH07301529GA SCH07301531GA SCH07301532GA SCH07301534GA SCH07301535GA
SCH07301540GA SCH07301541GA SCH07301542GA SCH07301543GA SCH07301544GA
SCH07301545GA SCH07301548GA SCH07301550GA SCH07301551GA SCH07301553GA
SCH07301554GA SCH07301555GA SCH07301556GA SCH07301558GA SCH07301560GA
SCH07301562GA SCH07301564GA SCH07301565GA SCH07301566GA SCH07301567GA
SCH07301568GA SCH07301569GA SCH07301571GA SCH07301572GA SCH07301573GA
SCH07301574GA SCH07301575GA SCH07301577GA SCH07301580GA SCH07301581GA
SCH07301582GA SCH07311583GA SCH07311586GA SCH07311587GA SCH07311591GA
SCH07311592GA SCH07311593GA SCH07311597GA SCH07311608GA SCH07311611GA
SCH07311613GA SCH07321667GA SCH07321686GA SCH07321694GA SCH07321698GA
SCH07321699GA SCH07321721GA SCH07331766GA SCH07341852GA SCH07361897GA
SCH07361927GA SCH07362014GA SCH07362027GA SCH07362046GA SCH07362047GA
SCH07362048GA SCH07362049GA SCH07362053GA SCH07362056GA SCH07372059GA
SCH07372086GA SCH07382337GA SCH07382338GA SCH07382341GA SCH07382343GA
SCH07382344GA SCH07392350GA SCH07392352GA SCH07392400GA SCH07392436GA
SCH07392437GA JA104290036GA JA104370161GA JA104380192GA JA104390295GA
JA104390313GA JA104390314GA JA104390315GA JA104390317GA JA104460552GA
JA104470591GA JA104531093GA JA104531110GA JA104531116GA JA104531143GA
JA105021248GA JA105021253GA JA105071395GA JA105071411GA JA105141715GA
JA105141716GA JA105141717GA JA105141718GA JA105181851GA JA105202014GA
JA105222072GA JA105282322GA JA105342529GA JA105513687GA JA105523759GA
JA105523763GA JA105523779GA JA105523790GA JA105523794GA JA106033886GA
JA106054039GA JA106074244GA JA106074253GA JA106074290GA JA106094376GA
JA106094424GA JA106094425GA JA106124553GA JA106134594GA JA106134598GA
JA106144669GA JA106144680GA JA106154726GA JA106164735GA JA106265212GA
JA106345518GA JA106345527GA JA106355556GA JA106365586GA JA106365593GA
JA106365610GA JA106395798GA SCH07110763GA SCH07150978GA SCH07161055GA
SCH07281441GA SCH07321737GA SCH07361991GA SCH07382241GA SCH07382269GA
SCH07382292GA SCH07382310GA SCH07382315GA SCH07382316GA SCH07382340GA
SCH07392384GA SCH07321750GA SCH07341849GA SCH06430021GA SCH06430031GA
SCH06430044GA SCH06430047GA SCH06440068GA SCH06440099GA SCH06440160GA
SCH06440178GA SCH06440191GA SCH06440197GA SCH06450206GA SCH06510424GA
SCH07040492GA SCH07040495GA SCH07050514GA SCH07050527GA SCH07050537GA
SCH07050558GA SCH07060580GA SCH07060600GA SCH07070622GA SCH07070627GA
SCH07070648GA SCH07110748GA SCH07110768GA SCH07110770GA SCH07110780GA
SCH07120827GA SCH07130840GA SCH07130843GA SCH07130845GA SCH07130848GA
SCH07130849GA SCH07130851GA SCH07130854GA SCH07140887GA SCH07150950GA
SCH07150964GA SCH07150999GA SCH07151004GA SCH07181100GA SCH07211200GA
SCH07221240GA SCH07281432GA SCH07281445GA SCH07291478GA SCH07301527GA
SCH07301536GA SCH07301537GA SCH07321725GA SCH07331754GA SCH07331804GA
SCH07331834GA SCH07341840GA SCH07341845GA SCH07341846GA SCH07341850GA
SCH07341866GA SCH07361972GA SCH07362031GA SCH07372075GA SCH07372085GA
SCH07372167GA SCH07382202GA SCH07382245GA SCH07382270GA SCH07382271GA
SCH07382277GA SCH07382278GA SCH07382290GA SCH07382293GA SCH07382296GA
SCH07382307GA SCH07382308GA SCH07382312GA SCH07382317GA SCH07382331GA
SCH07382332GA SCH07382335GA SCH07382336GA SCH07392348GA SCH07392349GA
SCH07392351GA SCH07392355GA SCH07392356GA SCH07392358GA SCH07392361GA
SCH07392362GA SCH07392364GA SCH07392372GA SCH07392375GA SCH07392376GA
SCH07392379GA SCH07392381GA SCH07392387GA SCH07392390GA SCH07392391GA
SCH07392404GA SCH07291463GA SCH07291477GA SCH07291493GA SCH07291496GA
SCH07372133GA SCH07382205GA SCH07382209GA SCH07382276GA SCH07382283GA
SCH07382306GA SCH07382319GA SCH07382323GA SCH07211225GA SCH07291485GA
SCH06430032GA SCH06430046GA SCH06440075GA SCH06440085GA SCH06440087GA
SCH06440088GA SCH06440089GA SCH06440091GA SCH06440097GA SCH06440130GA
SCH06440134GA SCH06440135GA SCH06440138GA SCH06440141GA SCH06440154GA
SCH06440192GA SCH06450225GA SCH06450229GA SCH06450236GA SCH06450246GA
SCH06450247GA SCH06450251GA SCH06450253GA SCH06450275GA SCH06470359GA
SCH06470360GA SCH06470362GA SCH06470364GA SCH06510386GA SCH06510387GA
SCH06510392GA SCH06510393GA SCH06510395GA SCH06510396GA SCH06510400GA
SCH06510401GA SCH06510402GA SCH06510403GA SCH06510405GA SCH06510406GA
SCH06510420GA SCH07040487GA SCH07040488GA SCH07040491GA SCH07050497GA
SCH07050515GA SCH07050532GA SCH07050533GA SCH07050549GA SCH07050557GA
SCH07060583GA SCH07060588GA SCH07060593GA SCH07060602GA SCH07070616GA
SCH07070624GA SCH07070629GA SCH07070632GA SCH07070633GA SCH07070636GA
SCH07070637GA SCH07070640GA SCH07070642GA SCH07070643GA SCH07070644GA
SCH07070647GA SCH07070649GA SCH07070656GA SCH07070657GA SCH07080684GA
SCH07080723GA SCH07080736GA SCH07110753GA SCH07110755GA SCH07110759GA
SCH07110766GA SCH07110776GA SCH07110783GA SCH07110785GA SCH07120823GA
SCH07120831GA SCH07130841GA SCH07130842GA SCH07130853GA SCH07130859GA
SCH07130861GA SCH07130863GA SCH07130880GA SCH07130881GA SCH07140884GA
SCH07140886GA SCH07140888GA SCH07140891GA SCH07140893GA SCH07140908GA
SCH07140914GA SCH07140916GA SCH07140919GA SCH07140932GA SCH07140933GA
SCH07150947GA SCH07150957GA SCH07150958GA SCH07150962GA SCH07150966GA
SCH07150967GA SCH07150972GA SCH07150973GA SCH07150977GA SCH07150979GA
SCH07150983GA SCH07150989GA SCH07161008GA SCH07161017GA SCH07161020GA
SCH07161021GA SCH07161022GA SCH07161026GA SCH07161027GA SCH07161031GA
SCH07161035GA SCH07161060GA SCH07161064GA SCH07161065GA SCH07161066GA
SCH07161072GA SCH07161073GA SCH07171075GA SCH07171085GA SCH07181105GA
SCH07181106GA SCH07191112GA SCH07191118GA SCH07191119GA SCH07191121GA
SCH07191122GA SCH07191124GA SCH07191125GA SCH07191128GA SCH07191130GA
SCH07191132GA SCH07191136GA SCH07191137GA SCH07191138GA SCH07191139GA
SCH07191140GA SCH07191157GA SCH07201167GA SCH07201176GA SCH07201177GA
SCH07211203GA SCH07211213GA SCH07211224GA SCH07221249GA SCH07231269GA
SCH07231270GA SCH07231282GA SCH07231289GA SCH07231290GA SCH07231298GA
SCH07231300GA SCH07231304GA SCH07231307GA SCH07231308GA SCH07231313GA
SCH07231317GA SCH07231318GA SCH07261332GA SCH07261352GA SCH07261366GA
SCH07281416GA SCH07281421GA SCH07301576GA SCH07301579GA SCH07321711GA
SCH07321730GA SCH07321738GA SCH07321751GA SCH07331809GA SCH07331813GA
SCH07331814GA SCH07331815GA SCH07331818GA SCH07331820GA SCH07331821GA
SCH07331825GA SCH07341844GA SCH07361938GA SCH07361984GA SCH07372057GA
SCH07372077GA SCH07372111GA SCH07372173GA SCH07372175GA SCH07372176GA
SCH07372178GA SCH07382212GA SCH07382222GA SCH07382226GA SCH07382238GA
SCH07382260GA SCH07382261GA SCH07382265GA JA104380184GA JA104380270GA
JA104380290GA JA104460537GA JA104490730GA JA104500843GA JA105021220GA
JA105021246GA JA105021255GA JA105021273GA JA105121649GA JA105121658GA
JA105252223GA JA105342519GA JA105402884GA JA106074259GA JA106104445GA
JA106405936GA SCH06440177GA SCH06450265GA SCH06450269GA SCH06450272GA
SCH06450273GA SCH06460278GA SCH06460281GA SCH06470319GA SCH07050512GA
SCH07050540GA SCH07060599GA SCH07110761GA SCH07150953GA SCH07161030GA
SCH07291486GA SCH07311620GA SCH07321732GA SCH07321735GA SCH07321743GA
SCH07331808GA SCH07331835GA SCH07382234GA SCH07382239GA SCH07382314GA
SCH07382342GA SCH07382345GA SCH07392383GA JA105342535GA JA106375632GA
SCH07161050GA SCH07231314GA SCH07331812GA SCH07372153GA SCH07372159GA
SCH07372164GA SCH06450252GA JA105091475GA SCH07261386GA SCH07291480GA
SCH06430014GA SCH06440179GA SCH06450228GA SCH06450234GA SCH06450242GA
SCH06450254GA SCH06450255GA SCH06450256GA SCH06450257GA SCH06450258GA
SCH06450259GA SCH06450260GA SCH06450267GA SCH06450274GA SCH06460277GA
SCH06460280GA SCH06470321GA SCH06470323GA SCH06470325GA SCH06470326GA
SCH06470330GA SCH06470334GA SCH06470337GA SCH06470339GA SCH07050541GA
SCH07120797GA SCH07161069GA SCH07181096GA SCH07311618GA SCH07311624GA
SCH07311627GA SCH07311628GA SCH07382191GA JA105222060GA JA106064055GA
JA106064056GA JA106064059GA JA106064060GA JA106385739GA JA106385746GA
JA106385747GA JA106385750GA JA106395759GA JA106395760GA JA106395777GA
JA106395796GA JA106415995GA JA106466172GA SCH06430008GA SCH06430011GA
SCH06430012GA SCH06430013GA SCH06430015GA SCH06430016GA SCH06430020GA
SCH06430022GA SCH06430023GA SCH06430024GA SCH06430025GA SCH06430026GA
SCH06430027GA SCH06430028GA SCH06430029GA SCH06430038GA SCH06440050GA
SCH06440057GA SCH06440062GA SCH06440142GA SCH06440145GA SCH06440146GA
SCH06440148GA SCH06440149GA SCH06440150GA SCH06440152GA SCH06440153GA
SCH06440157GA SCH06440158GA SCH06440159GA SCH06440163GA SCH06440164GA
SCH06440167GA SCH06440173GA SCH06440198GA SCH06440203GA SCH06440205GA
SCH06460287GA SCH07040493GA SCH07050502GA SCH07050510GA SCH07050554GA
SCH07060570GA SCH07060572GA SCH07060584GA SCH07060592GA SCH07060598GA
SCH07070611GA SCH07070612GA SCH07070620GA SCH07070641GA SCH07070652GA
SCH07070655GA SCH07140903GA SCH07191162GA SCH07211211GA SCH07211212GA
SCH07261346GA SCH07261350GA SCH07261359GA SCH07301528GA SCH07301547GA
SCH07301552GA SCH07301561GA SCH07301563GA SCH07301570GA SCH07301578GA
SCH07311588GA SCH07311589GA SCH07311590GA SCH07311594GA SCH07311617GA
SCH07311621GA SCH07311625GA SCH07321691GA SCH07321703GA SCH07321723GA
SCH07321731GA SCH07321736GA SCH07321740GA SCH07321741GA SCH07321753GA
SCH07331764GA SCH07331765GA SCH07331769GA SCH07331770GA SCH07331772GA
SCH07331779GA SCH07331784GA SCH07331785GA SCH07331787GA SCH07331789GA
SCH07331790GA SCH07331791GA SCH07331794GA SCH07331795GA SCH07331796GA
SCH07331800GA SCH07331801GA SCH07331802GA SCH07331807GA SCH07331816GA
SCH07331823GA SCH07331826GA SCH07331832GA SCH07351875GA SCH07351886GA
SCH07351889GA SCH07361900GA SCH07361914GA SCH07361916GA SCH07361989GA
SCH07361998GA SCH07362008GA SCH07372087GA SCH07372088GA SCH07372089GA
SCH07372090GA SCH07372103GA SCH07372104GA SCH07372105GA SCH07372108GA
SCH07372118GA SCH07382330GA JA105191913GA JA105191924GA JA105191932GA
JA105191936GA JA105191947GA JA105232110GA JA105242156GA JA105242182GA
JA105242184GA JA105252186GA JA105252187GA JA105252189GA JA105252208GA
JA105262317GA JA106225038GA JA106285245GA JA106295332GA JA106295387GA
JA106295394GA JA106335493GA JA106345506GA JA106345530GA JA106345532GA
JA106355543GA JA106355555GA JA106355559GA JA106355561GA JA106355563GA
JA106355564GA JA106355565GA JA106355572GA JA106365585GA JA106415990GA
JA106416003GA JA106416040GA JA106415984GA SCH07060596GA SCH07321746GA
SCH07382258GA JA105191910GA JA105212036GA JA105232106GA JA105242165GA
JA105262250GA JA105262256GA JA105322406GA JA105332419GA JA105433021GA
JA105463200GA JA106124580GA JA106235062GA SCH07140895GA JA105262285GA
JA105433050GA JA105453132GA JA105453171GA JA105463188GA SCH07120822GA
SCH07130852GA SCH07130860GA SCH07130872GA SCH07130874GA SCH07150970GA
SCH07150971GA SCH07150990GA SCH07151002GA SCH07161013GA SCH07161033GA
SCH07161046GA SCH07362024GA SCH06440125GA SCH06440172GA SCH06440180GA
SCH06440182GA SCH06440183GA SCH06440201GA SCH06450216GA SCH06450220GA
SCH06450222GA SCH06450226GA SCH06450237GA SCH06470350GA SCH06470358GA
SCH07050501GA SCH07050539GA SCH07080726GA SCH07080735GA SCH07080742GA
SCH07110771GA SCH07110774GA SCH07120802GA SCH07120805GA SCH07120807GA
SCH07120813GA SCH07120828GA SCH07130875GA SCH07130878GA SCH07140909GA
SCH07140910GA SCH07140911GA SCH07140920GA SCH07140921GA SCH07140923GA
SCH07140927GA SCH07150944GA SCH07191158GA SCH07201183GA SCH07261353GA
SCH07261372GA SCH07261382GA SCH07261389GA SCH07261390GA SCH07261393GA
SCH07281399GA SCH07281400GA SCH07281401GA SCH07281402GA SCH07281403GA
SCH07281404GA SCH07281407GA SCH07281408GA SCH07281409GA SCH07281410GA
SCH07281411GA SCH07281431GA SCH07281440GA SCH07281442GA SCH07281447GA
SCH07281449GA SCH07281451GA SCH07281454GA SCH07281457GA SCH07291465GA
SCH07291475GA SCH07291483GA SCH07291488GA SCH07291490GA SCH07291495GA
SCH07291499GA SCH07291500GA SCH07291501GA SCH07291502GA SCH07291503GA
SCH07291504GA SCH07291505GA SCH07291506GA SCH07291507GA SCH07291509GA
SCH07291510GA SCH07291512GA SCH07301515GA SCH07301520GA SCH07301521GA
SCH07301526GA SCH07301538GA SCH07301549GA SCH07301559GA SCH07311584GA
SCH07311585GA SCH07311595GA SCH07311596GA SCH07311598GA SCH07311599GA
SCH07311600GA SCH07311602GA SCH07311603GA SCH07311604GA SCH07311605GA
SCH07311606GA SCH07311607GA SCH07311609GA SCH07311610GA SCH07311612GA
SCH07311622GA SCH07311626GA SCH07311629GA SCH07311630GA SCH07311631GA
SCH07311633GA SCH07311634GA SCH07311635GA SCH07311638GA SCH07311642GA
SCH07311643GA SCH07311644GA SCH07311653GA SCH07321654GA SCH07321655GA
SCH07321656GA SCH07321657GA SCH07321658GA SCH07321660GA SCH07321661GA
SCH07321662GA SCH07321664GA SCH07321665GA SCH07321666GA SCH07321668GA
SCH07321669GA SCH07321670GA SCH07321671GA SCH07321673GA SCH07321674GA
SCH07321675GA SCH07321676GA SCH07321677GA SCH07321678GA SCH07321679GA
SCH07321680GA SCH07321683GA SCH07321685GA SCH07321687GA SCH07321688GA
SCH07321693GA SCH07321706GA SCH07321707GA SCH07321710GA SCH07321726GA
SCH07321742GA SCH07321749GA SCH07331788GA SCH07331829GA SCH07331836GA
SCH07341858GA SCH07341859GA SCH07341865GA SCH07341873GA SCH07351888GA
SCH07351891GA SCH07351892GA SCH07361901GA SCH07361908GA SCH07361912GA
SCH07361924GA SCH07361931GA SCH07361937GA SCH07361940GA SCH07361948GA
SCH07361949GA SCH07362021GA SCH07362032GA SCH07372095GA SCH07372097GA
SCH07372100GA SCH07372102GA SCH07382231GA SCH07382232GA SCH07382233GA
SCH07382242GA SCH07382253GA SCH07382254GA SCH07382264GA SCH07382324GA
SCH07382326GA JA105171813GA JA105171836GA JA105191941GA JA105191942GA
JA105191958GA JA105201984GA JA105252197GA JA105433035GA JA106023822GA
JA106023827GA JA106395888GA SCH06510408GA SCH06510435GA SCH07110788GA
SCH07110792GA SCH07130857GA SCH07130858GA SCH07140928GA SCH07140934GA
SCH07150984GA SCH07150996GA SCH07161029GA SCH07161057GA SCH07171077GA
SCH07171078GA SCH07171080GA SCH07181087GA SCH07181088GA SCH07181090GA
SCH07181091GA SCH07181094GA SCH07181095GA SCH07191108GA SCH07191126GA
SCH07201194GA SCH07211214GA SCH07281430GA SCH07311651GA SCH07321659GA
SCH07321663GA SCH07321681GA SCH07321682GA SCH07321692GA SCH07321701GA
SCH07321705GA SCH07321708GA SCH07321709GA SCH07321713GA SCH07321727GA
SCH07321728GA SCH07321729GA SCH07321739GA SCH07321747GA SCH07331757GA
SCH07331758GA SCH07331761GA SCH07331763GA SCH07331767GA SCH07331768GA
SCH07331773GA SCH07331775GA SCH07331776GA SCH07331777GA SCH07331778GA
SCH07331781GA SCH07331782GA SCH07331786GA SCH07331797GA SCH07361936GA
SCH07372065GA SCH07372069GA SCH07372071GA SCH07382273GA SCH07382304GA
SCH07382322GA SCH07382333GA SCH07392399GA SCH07392403GA SCH07392407GA
SCH07392410GA SCH07392419GA JA104510945GA JA104510966GA JA104520987GA
JA104521005GA JA105071405GA JA105071412GA JA106074263GA JA106094387GA
JA106094392GA JA106094395GA JA106164765GA JA106174804GA JA106184838GA
JA106184847GA JA106184851GA JA106184852GA JA106184858GA JA106184860GA
JA107096744GA JA107096746GA JA107096747GA JA107096748GA JA107096751GA
JA107096752GA JA107096755GA JA107096756GA JA107096774GA SCH06430037GA
SCH07201185GA SCH07201186GA SCH07211205GA SCH07311616GA SCH07321696GA
SCH07321697GA SCH07321719GA SCH07321720GA SCH07382216GA SCH07382227GA
SCH07382246GA SCH06430033GA SCH06440059GA SCH07040473GA SCH07040478GA
SCH07040482GA SCH07110746GA SCH07110765GA SCH07150945GA SCH07261365GA
SCH07261376GA SCH07261384GA SCH07261385GA SCH07351878GA SCH07351879GA
SCH07351884GA SCH07351885GA SCH07361909GA SCH07362025GA SCH07382309GA
JA106395812GA SCH07030458GA SCH07130883GA SCH07201178GA SCH07392460GA
SCH06440100GA SCH06510436GA SCH07030464GA SCH07050528GA SCH07070619GA
SCH07080695GA SCH07080699GA SCH07080709GA SCH07080716GA SCH07110750GA
SCH07120829GA SCH07372091GA SCH07382279GA SCH07382288GA SCH07382291GA
SCH07382302GA SCH07392392GA SCH07392395GA SCH07392396GA SCH07392397GA
SCH07392406GA SCH07392409GA JA105021203GA JA106305432GA JA106305450GA
JA106516571GA JA106516573GA JA106516578GA SCH07040475GA SCH07150997GA
SCH07311652GA SCH07321684GA SCH07321712GA SCH07321744GA JA105483353GA
SCH06230001GA SCH06230002GA SCH06320005GA SCH06320006GA SCH07050526GA
SCH07050531GA SCH07050547GA SCH07050550GA SCH07050551GA SCH07070614GA
SCH07150992GA SCH07221252GA SCH07221261GA SCH07231310GA SCH07261397GA
SCH07301546GA SCH07331805GA SCH07331824GA SCH07341843GA SCH07361915GA
SCH07361946GA SCH07361950GA SCH07362045GA SCH07362050GA SCH07362051GA
SCH07372058GA SCH07372064GA SCH07372099GA SCH07372117GA SCH07382200GA
SCH07382240GA SCH07382243GA SCH07382329GA SCH07392347GA SCH07392354GA
JA105463225GA JA105463228GA JA106023833GA JA106023851GA JA106486197GA
JA106486210GA JA106486211GA JA105191959GA JA106285243GA SCH07060571GA
SCH07120832GA SCH07080701GA SCH07080710GA SCH07110751GA SCH07110754GA
SCH07120811GA SCH07120836GA SCH07130856GA SCH07130862GA SCH07130864GA
SCH07130868GA SCH07130869GA SCH07281405GA SCH07281425GA SCH07321722GA
SCH07341838GA SCH07351876GA SCH07351890GA SCH07361893GA SCH07361902GA
SCH07361911GA SCH07361926GA SCH07361932GA SCH07361939GA SCH07372066GA
SCH06440147GA SCH06440156GA SCH06440165GA SCH06440166GA SCH06440170GA
SCH06440171GA SCH06440174GA SCH06440181GA SCH07040470GA SCH07050544GA
SCH07070625GA SCH07080674GA SCH07130865GA SCH07140900GA SCH07161039GA
SCH07161043GA SCH07161044GA SCH07161045GA SCH07161047GA SCH07161051GA
SCH07171079GA SCH07171083GA SCH07181089GA SCH07191111GA SCH07191114GA
SCH07191116GA SCH07201184GA SCH07261387GA SCH07291460GA SCH07301533GA
SCH07301557GA SCH07321690GA SCH07362042GA SCH07362044GA SCH07372068GA
JA105392804GA SCH06460279GA SCH06460285GA SCH06470335GA SCH06510411GA
SCH07050505GA SCH07140907GA SCH07140917GA SCH07140935GA SCH07140940GA
SCH07231301GA SCH07372062GA SCH07372101GA SCH07382199GA SCH07382204GA
SCH07382213GA SCH07382219GA SCH07382220GA SCH07382221GA JA104360105GA
JA104430389GA JA105051303GA JA105101506GA JA105101514GA JA105161762GA
JA105453183GA JA106285312GA JA106345517GA JA106345528GA JA106355568GA
JA106355576GA JA106365588GA JA106365595GA JA106375613GA JA106375614GA
JA106375615GA JA106375617GA JA106375618GA JA106395856GA JA106395859GA
JA106395870GA JA106395871GA JA106395872GA JA106395873GA JA106395874GA
JA106395875GA JA106395879GA JA106395884GA JA106395891GA JA106395897GA
JA106405935GA JA106405968GA JA106405969GA JA106416010GA JA106486187GA
JA106486250GA JA106486253GA JA106094355GA SCH06440143GA SCH06440168GA
SCH06440176GA SCH07110782GA SCH07161053GA SCH07171076GA SCH07171081GA
SCH07171084GA SCH07171086GA SCH07181093GA SCH07181097GA SCH07191109GA
SCH07211220GA SCH07331755GA SCH07341851GA SCH07361943GA SCH07382251GA
SCH07382256GA SCH07382257GA SCH07382268GA SCH07382286GA SCH07382300GA
SCH07392357GA SCH07392388GA JA104380218GA JA104390305GA JA104440464GA
JA106164760GA JA106204942GA JA106204945GA JA106204948GA JA106204955GA
JA106214988GA JA106214992GA JA106214998GA JA106215000GA JA106215014GA
JA106215016GA JA106215021GA JA106215023GA JA106225025GA JA106225053GA
JA106235065GA JA106235069GA JA106235070GA JA106235071GA JA106235072GA
JA106375624GA JA106375636GA JA106375641GA JA107026678GA JA107036702GA
JA107036704GA JA107036707GA JA107036709GA JA107036710GA JA107036717GA
JA107036718GA JA107036719GA JA107036722GA JA107036726GA JA107036729GA
SCH07030466GA SCH07050543GA SCH07090745GA SCH07040479GA SCH07050499GA
SCH07060579GA SCH07060586GA SCH07070630GA SCH07070635GA SCH07080740GA
SCH07110772GA SCH07120810GA SCH07150988GA SCH07161034GA SCH07191141GA
SCH07191145GA SCH07191146GA SCH07191147GA SCH07191155GA SCH07191164GA
SCH07201168GA SCH07231292GA SCH07231309GA SCH07281406GA SCH07281414GA
SCH07281415GA SCH07281424GA SCH07281433GA SCH07281437GA SCH07311619GA
SCH07321700GA SCH07331793GA SCH07331806GA SCH07331810GA SCH07331811GA
SCH07331817GA SCH07331822GA SCH07361899GA SCH07361903GA SCH07361907GA
SCH07361913GA SCH07361921GA SCH07361922GA SCH07361925GA SCH07382294GA
SCH07382325GA SCH07392411GA SCH07392420GA JA105513611GA JA105513614GA
JA106285264GA SCH07392461GA SCH07040494GA SCH07080717GA SCH07080727GA
SCH07080729GA SCH07110760GA SCH07110779GA SCH07130873GA SCH07140905GA
SCH07140913GA SCH07140915GA SCH07140926GA SCH07140929GA SCH07372070GA
SCH07382259GA SCH07382295GA SCH07382313GA SCH07382321GA SCH07392373GA
SCH07392380GA SCH07392385GA SCH07392386GA SCH07392417GA JA105402895GA
SCH06430017GA SCH06430019GA SCH07050504GA SCH07060563GA SCH07070623GA
SCH07080721GA SCH07120814GA SCH07130846GA SCH07161067GA SCH07161074GA
SCH07171082GA SCH07191110GA SCH07211223GA SCH07211226GA SCH07231295GA
SCH07261340GA SCH07372092GA SCH07060564GA SCH07070653GA SCH07191115GA
SCH07211198GA SCH07211202GA SCH07211204GA SCH07281422GA SCH07331799GA
SCH07211201GA SCH07211206GA SCH07211209GA SCH07221230GA SCH07221242GA
SCH07321672GA SCH07321714GA SCH07361917GA SCH07361918GA SCH07361919GA
SCH07361920GA SCH07361923GA SCH07361933GA SCH07361941GA SCH07361942GA
JA104500798GA JA104500801GA JA104500804GA JA104500805GA SCH07110749GA
SCH07261368GA SCH07311614GA SCH06470329GA SCH06470341GA SCH07231276GA
SCH07231285GA SCH06450270GA SCH06460305GA SCH06470369GA SCH07050513GA
SCH07050552GA SCH07060589GA SCH07070617GA SCH07070628GA SCH07070631GA
SCH07070659GA SCH07070664GA SCH07080670GA SCH07080681GA SCH07181103GA
SCH07321745GA SCH07321748GA SCH07331774GA SCH07331792GA SCH07351883GA
SCH07351887GA SCH07361894GA SCH07361929GA SCH07361990GA SCH07362022GA
JA106285289GA JA106285315GA JA106295318GA JA106295319GA JA106295320GA
JA106295322GA JA106295323GA JA106295324GA JA106295334GA JA106295335GA
JA106295336GA JA106295337GA JA106295347GA SCH06440061GA SCH07050507GA
SCH07050536GA SCH07060601GA SCH07070607GA SCH07120796GA SCH07120835GA
SCH07150986GA SCH07161010GA SCH07161059GA SCH07161061GA SCH07191163GA
SCH07201170GA SCH07201181GA SCH07201189GA SCH07201191GA SCH07211207GA
SCH07211210GA SCH07211215GA SCH07211216GA SCH07211218GA SCH07211219GA
SCH07211221GA SCH07221237GA SCH07221241GA SCH07221245GA SCH07231316GA
SCH07261333GA SCH07261335GA SCH07261336GA SCH07261338GA SCH07261339GA
SCH07261347GA SCH07261349GA SCH07261351GA SCH07261354GA SCH07261358GA
SCH07261363GA SCH07261364GA SCH07261373GA SCH07261379GA SCH07261388GA
SCH07281418GA SCH07281423GA SCH07281426GA SCH07291459GA SCH07361983GA
SCH07372063GA SCH07372074GA SCH07372149GA SCH07372172GA SCH07372174GA
SCH07372180GA SCH07372181GA SCH07372183GA SCH07382187GA SCH07382190GA
SCH07382193GA SCH07382218GA SCH07382280GA SCH07382287GA SCH07392360GA
SCH07392365GA SCH07392366GA SCH07392367GA SCH07392368GA SCH07392369GA
SCH07392370GA SCH07392371GA SCH07392374GA SCH07392377GA SCH07392382GA
SCH07392412GA JA104470649GA JA104480665GA JA104480686GA JA105021274GA
JA106204924GA JA106235086GA SCH07191127GA SCH07191152GA SCH07060577GA
SCH07080694GA SCH07221250GA SCH07221255GA SCH07221258GA SCH07221259GA
SCH07231264GA SCH07291469GA SCH07301530GA SCH07341842GA SCH07341848GA
SCH07341863GA SCH07341868GA SCH07361970GA SCH07372123GA SCH07372151GA
JA105322360GA JA105322371GA JA105513643GA JA105513681GA JA105513696GA
SCH06440169GA SCH06470355GA SCH06510407GA SCH07050508GA SCH07050511GA
SCH07050517GA SCH07070663GA SCH07070665GA SCH07080677GA SCH07151001GA
SCH07161037GA SCH07161070GA SCH07181099GA SCH07261331GA SCH07291491GA
SCH07392393GA SCH07392394GA SCH07392408GA JA104531112GA JA104531114GA
JA104531117GA JA105483270GA JA106043927GA JA106134627GA JA106134629GA
JA106315454GA SCH06440140GA SCH06510399GA SCH06510432GA SCH07030453GA
SCH07030455GA SCH07030463GA SCH07191165GA SCH07201166GA SCH07201182GA
SCH07231288GA SCH07361965GA SCH07361966GA SCH07361971GA SCH07392429GA
SCH07392430GA SCH07392444GA SCH06440098GA SCH06440105GA SCH06440127GA
SCH06450261GA SCH06510394GA SCH07040476GA SCH07040483GA SCH07040484GA
SCH07050509GA SCH07050519GA SCH07050553GA SCH07070621GA SCH07070638GA
SCH07070645GA SCH07080673GA SCH07080702GA SCH07080703GA SCH07080718GA
SCH07080730GA SCH07080737GA SCH07080744GA SCH07110767GA SCH07110786GA
SCH07120793GA SCH07120801GA SCH07120804GA SCH07120808GA SCH07120815GA
SCH07120824GA SCH07150969GA SCH07150975GA SCH07150976GA SCH07150980GA
SCH07150985GA SCH07150987GA SCH07150991GA SCH07150993GA SCH07150995GA
SCH07150998GA SCH07161024GA SCH07161068GA SCH07191113GA SCH07291461GA
SCH07291494GA SCH07291498GA SCH07291508GA SCH07341864GA SCH07372073GA
SCH07372080GA SCH07372084GA SCH07372096GA SCH07382215GA SCH07382252GA
SCH07382263GA SCH07382285GA SCH07382297GA SCH07382305GA JA104380206GA
JA105332453GA JA105342550GA JA105352552GA JA105433010GA JA106265209GA
JA106496370GA JA106496373GA JA106496374GA JA106496381GA JA106496384GA
JA106496385GA JA106496388GA JA106496390GA JA106496401GA JA106496403GA
JA106496404GA JA106496405GA JA106496408GA JA106506415GA JA106506417GA
JA106506468GA JA106506470GA JA106506471GA JA106506472GA JA106506473GA
JA106506474GA JA106506487GA JA106506512GA JA106516525GA JA106516528GA
SCH06440108GA SCH06440129GA SCH06440131GA SCH06450213GA SCH06450221GA
SCH06510434GA SCH07030459GA SCH07140939GA SCH07291474GA SCH07311636GA
SCH07311637GA SCH07341870GA SCH07361959GA SCH07372136GA SCH07372137GA
SCH07372143GA SCH07372147GA SCH07372148GA SCH07372163GA SCH07372170GA
JA105493431GA SCH06460282GA SCH06460288GA SCH06460289GA SCH06470331GA
SCH06470365GA SCH06470370GA SCH07060591GA SCH07070662GA SCH07140941GA
SCH07321695GA SCH07050538GA SCH07080728GA SCH07080738GA SCH07080739GA
SCH07110762GA SCH07110778GA SCH07110784GA SCH07261356GA SCH07382223GA
SCH07382244GA SCH07382248GA JA105443088GA JA105453123GA JA105483333GA
JA105483336GA JA105483342GA JA105483347GA JA105483351GA JA105483352GA
JA105483354GA JA105483358GA JA105483361GA JA105483362GA JA105483364GA
JA105493367GA JA105493369GA JA105493372GA JA105493375GA JA105493377GA
JA105493379GA JA105493384GA JA105493385GA JA105493386GA JA105493390GA
JA105493391GA JA105493396GA JA105493397GA JA105493400GA JA105493406GA
JA105493407GA JA105493408GA JA105493409GA JA105493410GA JA105493413GA
JA105493416GA JA105493417GA JA105493418GA JA105493419GA JA105493420GA
JA105493424GA JA105493425GA JA105493427GA JA105493429GA JA105493432GA
JA105493433GA JA105493434GA JA105493435GA JA105493436GA JA105493437GA
JA105493440GA JA105493441GA JA105493445GA JA105493446GA JA105493447GA
JA105493448GA JA105493449GA JA105493450GA JA105493451GA JA105493453GA
JA105493455GA JA105503461GA JA105503462GA JA105503465GA JA105503470GA
JA105503472GA JA105503473GA JA106013815GA JA106023848GA JA106104479GA
JA106204962GA SCH06440093GA SCH06440101GA SCH06440102GA SCH06440107GA
SCH06460300GA SCH06460309GA SCH07070660GA SCH07201193GA SCH07231293GA
SCH07060565GA SCH06460302GA SCH06460310GA SCH06460312GA SCH07050518GA
SCH07080683GA SCH07040471GA SCH07070654GA SCH07070661GA SCH07080671GA
SCH07120794GA SCH07161023GA SCH07191142GA SCH07191143GA SCH07191144GA
SCH07191150GA SCH07191151GA SCH07191153GA SCH07191159GA SCH07301517GA
JA105161760GA JA106124571GA JA106204967GA SCH06440081GA SCH06470327GA
SCH06470354GA SCH06470361GA SCH07050525GA SCH07050560GA SCH07060567GA
SCH07060595GA SCH07070608GA SCH07080719GA SCH07110787GA SCH07221236GA
SCH07221238GA SCH07221239GA SCH07221243GA SCH07221247GA SCH07221253GA
SCH07231263GA SCH07361986GA SCH07362011GA SCH07382217GA SCH07382235GA
SCH07382236GA SCH07382237GA SCH07382303GA SCH07382334GA SCH06440104GA
SCH06470316GA SCH07060569GA SCH07150959GA SCH07150965GA SCH07161018GA
SCH07161032GA SCH07221257GA SCH07221260GA SCH07231262GA SCH07231265GA
SCH07231267GA SCH07231274GA SCH07231275GA SCH07231277GA SCH07231278GA
SCH07231279GA SCH07372157GA SCH06430010GA SCH06440070GA SCH06440071GA
SCH06440078GA SCH06440086GA SCH06440090GA SCH06440092GA SCH06440096GA
SCH06440106GA SCH06440109GA SCH06440110GA SCH06440111GA SCH06440113GA
SCH06440115GA SCH06440116GA SCH06440124GA SCH06440132GA SCH06440137GA
SCH06440139GA SCH06440199GA SCH06510397GA SCH06510416GA SCH06510422GA
SCH06510423GA SCH06510425GA SCH07040489GA SCH07040490GA SCH07050523GA
SCH07080689GA SCH07080696GA SCH07080704GA SCH07080732GA SCH07080734GA
SCH07080741GA SCH07110752GA SCH07110758GA SCH07110769GA SCH07110773GA
SCH07110775GA SCH07110781GA SCH07110789GA SCH07110791GA SCH07120795GA
SCH07120798GA SCH07120799GA SCH07120800GA SCH07120803GA SCH07120812GA
SCH07120817GA SCH07120819GA SCH07120820GA SCH07130866GA SCH07140885GA
SCH07140918GA SCH07140925GA SCH07150946GA SCH07150968GA SCH07150974GA
SCH07161011GA SCH07161028GA SCH07161071GA SCH07181098GA SCH07191120GA
SCH07191161GA SCH07201172GA SCH07201192GA SCH07201195GA SCH07211208GA
SCH07221248GA SCH07231315GA SCH07261319GA SCH07261320GA SCH07261321GA
SCH07261322GA SCH07261323GA SCH07261324GA SCH07261325GA SCH07261326GA
SCH07261327GA SCH07261328GA SCH07261329GA SCH07261330GA SCH07261337GA
SCH07261344GA SCH07261345GA SCH07261348GA SCH07261355GA SCH07261357GA
SCH07261360GA SCH07261361GA SCH07261374GA SCH07261392GA SCH07261396GA
SCH07281412GA SCH07281413GA SCH07281417GA SCH07281419GA SCH07281420GA
SCH07281427GA SCH07281428GA SCH07281435GA SCH07281436GA SCH07281438GA
SCH07281439GA SCH07281443GA SCH07281444GA SCH07291472GA SCH07291473GA
SCH07291489GA SCH07291497GA SCH07311601GA SCH07321733GA SCH07321734GA
SCH07331798GA SCH07351877GA SCH07361895GA SCH07361896GA SCH07361898GA
SCH07361928GA SCH07362007GA SCH07362043GA SCH07372060GA SCH07372061GA
SCH07372076GA SCH07372079GA SCH07372083GA SCH07372098GA SCH07372106GA
SCH07372107GA SCH07372109GA SCH07372110GA SCH07372112GA SCH07372113GA
SCH07372115GA SCH07372116GA SCH07372184GA SCH07372185GA SCH07372186GA
SCH07382188GA SCH07382189GA SCH07382192GA SCH07382194GA SCH07382195GA
SCH07382197GA SCH07382198GA SCH07382201GA SCH07382203GA SCH07382206GA
SCH07382207GA SCH07382208GA SCH07382210GA SCH07382211GA SCH07382249GA
SCH07382299GA SCH07392418GA SCH07392423GA SCH07392425GA JA104440445GA
JA104500837GA JA105201999GA JA105202015GA JA105202016GA JA105202017GA
JA106385743GA JA106395771GA JA106395775GA SCH07201175GA JA107026659GA
SCH07080712GA SCH07201169GA SCH07361935GA SCH06470342GA SCH07050522GA
SCH07140937GA SCH07150981GA SCH07361904GA SCH07130837GA SCH07130847GA
SCH07341867GA SCH06430034GA SCH06430042GA SCH06440054GA SCH06440079GA
SCH06440112GA SCH06440118GA SCH06440120GA SCH06450207GA SCH06450240GA
SCH06450243GA SCH06450248GA SCH06450249GA SCH06450250GA SCH06450266GA
SCH06450268GA SCH06460286GA SCH06470332GA SCH06510385GA SCH06510413GA
SCH07050545GA SCH07080711GA SCH07130876GA SCH07140930GA SCH07140931GA
SCH07140943GA SCH07150949GA SCH07150954GA SCH07181104GA SCH07181107GA
SCH07191131GA SCH07191134GA SCH07211222GA SCH07221231GA SCH07221232GA
SCH07221246GA SCH07261342GA SCH07331803GA SCH07372179GA SCH07372182GA
SCH07382262GA SCH07382320GA SCH07392363GA SCH07392413GA SCH07392415GA
SCH07392416GA SCH07392422GA SCH07392438GA SCH07392439GA SCH07392441GA
SCH07392445GA SCH07392453GA SCH07392456GA SCH07392467GA SCH07392468GA
SCH06450224GA SCH06460304GA SCH06470347GA SCH07030460GA SCH07040477GA
SCH07040481GA SCH07040485GA SCH07070613GA SCH07130855GA SCH07181101GA
SCH07231281GA SCH07261334GA SCH07261367GA SCH07261370GA SCH07261375GA
SCH07261378GA SCH07261380GA SCH07261394GA SCH07281434GA SCH07281450GA
SCH07281453GA SCH07281455GA SCH07331759GA SCH07331830GA SCH07331837GA
SCH07351874GA SCH07361973GA SCH07050548GA SCH07382196GA SCH07382214GA
SCH07382272GA SCH07392378GA SCH07040486GA SCH07050521GA SCH07050535GA
SCH07050542GA SCH07110790GA SCH07130877GA SCH07130882GA SCH07151005GA
SCH07191135GA SCH07321752GA SCH07331756GA SCH07361930GA SCH07361944GA
SCH07361945GA SCH07361947GA SCH07361951GA SCH07361952GA SCH07361953GA
SCH07361954GA SCH07361955GA SCH07361961GA SCH07361962GA SCH07361963GA
SCH07361979GA SCH07361980GA SCH07361981GA SCH07361982GA SCH07361985GA
SCH07361988GA SCH07361992GA SCH07361993GA SCH07361994GA SCH07361995GA
SCH07361996GA SCH07361997GA SCH07361999GA SCH07362000GA SCH07362001GA
SCH07362005GA SCH07362009GA SCH07362010GA SCH07362012GA SCH07362013GA
SCH07362015GA SCH07362016GA SCH07362017GA SCH07362018GA SCH07362019GA
SCH07362020GA SCH07362030GA SCH07362038GA SCH07362039GA SCH07362041GA
SCH07362052GA SCH07362054GA SCH07362055GA SCH07372072GA SCH07372093GA
SCH07372094GA SCH07392405GA JA104380228GA JA104380248GA JA104380266GA
JA104521002GA JA105513557GA JA106144662GA JA106174806GA SCH07080715GA
SCH07161058GA JA105232089GA JA104440467GA JA106506477GA JA104430398GA
JA105402885GA JA105433013GA JA105433019GA JA105433024GA JA105151747GA
JA106154714GA JA106164758GA JA106355575GA JA106365583GA JA105473247GA
JA105473248GA JA105513622GA JA105523710GA JA106215024GA JA106225041GA
JA106225044GA JA106064150GA JA106385658GA JA106204933GA JA106214991GA
SCH07040474GA SCH07050503GA SCH07060566GA SCH07060585GA SCH07070650GA
SCH07070651GA SCH07080672GA SCH07080682GA SCH07080685GA SCH07080688GA
SCH07080691GA SCH07080697GA SCH07080698GA SCH07080700GA SCH07080705GA
SCH07080706GA SCH07080725GA SCH07110747GA SCH07120833GA SCH07140892GA
SCH07140897GA SCH07140901GA SCH07140902GA SCH07231294GA SCH07231312GA
SCH07331783GA SCH07341869GA SCH07341871GA SCH07341872GA SCH07361910GA
SCH07361960GA SCH07361967GA SCH07361968GA SCH07372122GA SCH07372129GA
SCH07321716GA SCH07331762GA SCH06460284GA SCH07070639GA SCH07080733GA
SCH07231283GA SCH07341855GA SCH07362034GA SCH07331760GA SCH07331771GA
SCH07331780GA SCH06440193GA SCH06440200GA SCH07140924GA SCH07161016GA
SCH07211217GA SCH07291514GA SCH07301539GA SCH07341862GA SCH07362023GA
SCH07362029GA SCH07362035GA SCH06440194GA SCH06450233GA SCH06450263GA
SCH06460291GA SCH06460303GA SCH06460307GA SCH06470313GA SCH06470314GA
SCH06470345GA SCH06510404GA SCH07030454GA SCH07030465GA SCH07030467GA
SCH07030468GA SCH07050498GA SCH07050524GA SCH07060568GA SCH07060575GA
SCH07080690GA SCH07110757GA SCH07120809GA SCH07150952GA SCH07161012GA
SCH07161014GA SCH07161036GA SCH07221256GA SCH07261377GA SCH07261381GA
SCH07261395GA SCH07291462GA SCH07291464GA SCH07291466GA SCH07291470GA
SCH07291484GA SCH07361905GA SCH07361906GA SCH07372124GA SCH07281446GA
SCH06450244GA SCH06460292GA SCH06510383GA SCH07080686GA SCH07281448GA
SCH07291481GA SCH07080680GA SCH07080743GA SCH07120816GA SCH07191149GA
SCH07191160GA SCH07201179GA SCH07201180GA SCH07211228GA SCH07281452GA
SCH07281456GA SCH07311645GA SCH07311649GA SCH07311650GA SCH07331819GA
SCH07331828GA SCH07351880GA SCH07351882GA SCH07361978GA SCH07362003GA
SCH07362004GA SCH07231306GA SCH07311639GA SCH07080708GA SCH06460301GA
SCH06460311GA SCH07211229GA SCH07382230GA SCH07221234GA SCH06440066GA
SCH06440188GA SCH06440189GA SCH06440195GA SCH06460283GA SCH07191129GA
SCH07191133GA SCH07321689GA SCH07361974GA SCH07392440GA SCH07392450GA
SCH06470315GA SCH07070634GA SCH07070666GA SCH07130879GA SCH07181102GA
SCH07050500GA SCH07050530GA SCH07050555GA SCH07060562GA SCH07060576GA
SCH07060582GA SCH07070603GA SCH07070604GA SCH07070605GA SCH07070606GA
SCH07070609GA SCH07201188GA SCH07221251GA SCH07231271GA SCH07361958GA
SCH07361969GA SCH07361976GA SCH07362040GA SCH07372119GA SCH07372126GA
SCH07372127GA SCH07382228GA SCH07382229GA SCH07070667GA SCH06440114GA
SCH07392432GA SCH07392442GA SCH07130838GA SCH07050559GA SCH07130867GA
SCH07392465GA SCH07050529GA SCH07231273GA SCH07060597GA SCH06470346GA
SCH07080675GA SCH07080676GA SCH07080678GA SCH07080679GA SCH07372144GA
SCH07372158GA SCH07372160GA SCH07372165GA SCH07372166GA SCH07372171GA
SCH07201196GA SCH07201197GA SCH07331831GA SCH07331833GA SCH07362033GA
SCH07372067GA SCH07372125GA SCH07372128GA SCH06430040GA SCH07130850GA
SCH07191156GA SCH07231299GA SCH07301518GA SCH07231287GA SCH07050546GA
SCH07060561GA SCH07080692GA SCH07191117GA SCH07191123GA SCH07281458GA
SCH07372161GA JA106255173GA SCH06440095GA SCH06440103GA SCH06440186GA
SCH06450218GA SCH06450276GA SCH06460306GA SCH07040472GA SCH07070615GA
SCH07070618GA SCH07070646GA SCH07080731GA SCH07130870GA SCH07140899GA
SCH07150951GA SCH07150955GA SCH07150956GA SCH07150961GA SCH07161038GA
SCH07161049GA SCH07161052GA SCH07181092GA SCH07201187GA SCH07201190GA
SCH07211199GA SCH07221235GA SCH07231286GA SCH07231305GA SCH07261362GA
SCH07261398GA SCH07291476GA SCH07291482GA SCH07341841GA SCH07341847GA
SCH07351881GA SCH07361975GA SCH07361977GA SCH07361987GA SCH07362002GA
SCH07362036GA SCH07392427GA SCH07392449GA SCH06430018GA SCH06430043GA
SCH06440055GA SCH06440133GA SCH06440196GA SCH06440204GA SCH06450211GA
SCH06450212GA SCH06450239GA SCH06450245GA SCH06450271GA SCH06460290GA
SCH06470363GA SCH06510415GA SCH06510433GA SCH07030457GA SCH07040480GA
SCH07060578GA SCH07060581GA SCH07060587GA SCH07070658GA SCH07080668GA
SCH07080687GA SCH07080720GA SCH07080724GA SCH07120821GA SCH07150982GA
SCH07161015GA SCH07161041GA SCH07161048GA SCH07231266GA SCH07231291GA
SCH07261341GA SCH07261369GA SCH07261371GA SCH07261383GA SCH07281429GA
SCH07291467GA SCH07372078GA SCH07392428GA SCH07392431GA JA104370151GA
JA105021186GA JA105101522GA JA105322353GA JA105322369GA JA105443062GA
JA105443063GA JA106043988GA SCH06450230GA SCH06450235GA SCH06450262GA
SCH06450264GA SCH07361956GA SCH07361957GA SCH07362037GA JA106054021GA
JA106054022GA JA106054024GA JA106054025GA JA106285262GA JA106285292GA
JA106355536GA SCH06470328GA SCH07060594GA SCH07150963GA SCH07291468GA
SCH07321718GA SCH07361964GA SCH07362006GA SCH07321715GA SCH07321717GA
SCH07120818GA SCH07120826GA SCH07120834GA SCH07130839GA SCH07130844GA
SCH07161056GA SCH07201171GA SCH07201173GA SCH07201174GA SCH07211227GA
SCH07221254GA SCH07231280GA SCH07231284GA SCH07231296GA SCH07231297GA
SCH07231302GA SCH07231303GA SCH07231311GA SCH07291487GA SCH07311641GA
SCH07311646GA SCH07311647GA SCH07321702GA SCH07321704GA SCH07341839GA
SCH07341854GA SCH07341856GA SCH07341857GA SCH07341860GA SCH07341861GA
SCH07372121GA SCH07372131GA SCH07372132GA SCH07372135GA SCH07372139GA
SCH07372140GA SCH07372141GA SCH07372142GA SCH07372145GA SCH07372146GA
SCH07372152GA SCH07372154GA SCH07372155GA SCH07372156GA SCH07372162GA
SCH07372168GA SCH07372169GA SCH07372177GA SCH07382224GA SCH07382225GA
SCH07382328GA SCH07030461GA SCH07030462GA SCH07321724GA SCH06440073GA
SCH06440074GA SCH06470317GA SCH06470318GA SCH06470320GA SCH06470322GA
SCH06470324GA SCH06470333GA SCH06470336GA SCH06470338GA SCH06470340GA
SCH06470343GA SCH06470344GA SCH06470348GA SCH06470349GA SCH06470351GA
SCH06470353GA SCH06470356GA SCH06470357GA SCH06510384GA SCH07030450GA
SCH07030451GA SCH07030452GA SCH07030456GA SCH07040469GA SCH07050516GA
SCH07060573GA SCH07060574GA SCH07080669GA SCH07080707GA SCH07130871GA
SCH07140896GA SCH07140898GA SCH07151007GA SCH07161040GA SCH07161042GA
SCH07231268GA SCH07231272GA SCH07261391GA SCH07291471GA SCH07311615GA
SCH07362026GA SCH07362028GA SCH07372081GA SCH07372082GA SCH07372134GA
SCH07291479GA SCH06450231GA SCH06450241GA SCH06460308GA SCH07080693GA
SCH07080713GA SCH07080722GA SCH07110756GA SCH07140889GA SCH07372114GA
SCH07372120GA SCH06440162GA SCH06450238GA SCH07050534GA SCH07191148GA
SCH07311623GA SCH07311632GA SCH07311640GA SCH07311648GA JA107026656GA
JA107026685GA JA107026690GA JA107036711GA JA107036732GA SCH06470366GA
SCH06470367GA SCH06470368GA SCH06490371GA SCH06490372GA SCH06490373GA
SCH06490374GA SCH06490375GA SCH06490376GA SCH06520437GA SCH06520438GA
SCH06520439GA SCH06520440GA SCH06520441GA SCH06520442GA SCH06520443GA
SCH06520444GA SCH06520445GA SCH06520446GA SCH06520447GA SCH06520448GA
SCH07120825GA SCH07191154GA SCH07331827GA SCH07341853GA SCH07361934GA
SCH07372130GA SCH07372138GA SCH07372150GA SCH07382247GA SCH07382250GA
SCH07382255GA SCH07382266GA SCH07382267GA SCH07382274GA SCH07382275GA
SCH07382281GA SCH07382282GA SCH07382284GA SCH07382289GA SCH07382298GA
SCH07382301GA SCH07382311GA SCH07382318GA SCH07382327GA SCH07382339GA
SCH07392346GA SCH07392359GA SCH07392389GA SCH07392398GA SCH07392401GA
SCH07392402GA SCH07392414GA SCH07392421GA SCH07392424GA SCH07392426GA
SCH07392433GA SCH07392434GA SCH07392435GA SCH07392443GA SCH07392446GA
SCH07392447GA SCH07392448GA SCH07392451GA SCH07392452GA SCH07392454GA
SCH07392455GA SCH07392457GA SCH07392458GA SCH07392459GA SCH07392462GA
SCH07392463GA SCH07392464GA SCH07392466GA SCH07392469GA SCH07402470GA
SCH07402471GA SCH07402472GA SCH07402473GA SCH07402474GA SCH07402475GA
SCH07402476GA SCH07402477GA SCH07402478GA SCH07402479GA SCH07402480GA
SCH07402481GA SCH07402482GA SCH07402483GA SCH07402484GA SCH07402485GA
SCH07402486GA SCH07402487GA SCH07402488GA SCH07402489GA SCH07402490GA
SCH07402491GA SCH07402492GA SCH07402493GA SCH07402494GA SCH07402495GA
SCH07402496GA SCH07402497GA SCH07402498GA SCH07402499GA SCH07402500GA
SCH07402501GA SCH07402502GA SCH07402503GA SCH07402504GA SCH07402505GA
SCH07402506GA SCH07402507GA SCH07402508GA SCH07402509GA SCH07402510GA
SCH07402511GA SCH07402512GA SCH07402513GA SCH07402514GA SCH07402515GA
SCH07402516GA SCH07402517GA SCH07402518GA SCH07402519GA SCH07402520GA
SCH07402521GA SCH07402522GA SCH07402523GA SCH07402524GA SCH07402525GA
SCH07402526GA SCH07402527GA SCH07402528GA SCH07402529GA SCH07402530GA
SCH07402531GA SCH07402532GA SCH07402533GA SCH07402534GA SCH07402535GA
SCH07402536GA SCH07402537GA SCH07412538GA SCH07412539GA SCH07412540GA
SCH07412541GA SCH07412542GA SCH07412543GA SCH07412544GA SCH07412545GA
SCH07412546GA SCH07412547GA SCH07412548GA SCH07412549GA SCH07412550GA
SCH07412551GA SCH07412552GA SCH07412553GA
RECALLING
FIRM/MANUFACTURER
Recalling Firm: General Electric Medical Systems
Information Technology, Wauwatosa, WI,
Manufacturer: General Electric Medical Systems Information Technology,
Milwaukee, WI.
REASON Potential for Loss of Audible Alarming
and ECG Tab Setting Changes; from Clinical Information Center (CIC) Pro v5.0.3
& 5.0.6 when used in combination with Telemetry and bedside
monitors.
VOLUME OF PRODUCT IN COMMERCE 3,115
units
DISTRIBUTION Nationwide and
Internationally
PRODUCT
a)
Sechrist Hyperbaric Chamber Gurney, Standard Gurney & Stretcher Model,
P/N: 21502,
b) Sechrist
Hyperbaric Chamber Gurney, Standard Gurney & Deluxe Wide
Stretcher Model, P/N 21464,
c)
Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Deluxe Wide
Stretcher Model, P/N 21465,
d)
Sechrist Hyperbaric Chamber Gurney, Hydraulic Gurney & Standard Stretcher
Model, P/N 21466,
e) Sechrist
Hyperbaric Chamber Gurney, Standard Gurney without Side rails &
Stretcher Model, P/N 21487,
CODE
Serial Numbers: (all Model
Numbers-21502, 21464, 21465, 21466. and 21487) 0604081092 0606087510 0503071536
0503071538 0408061454 0408061455 0408060131 0408061453 0609082336 0604081093
0606087506 0508081371 0508081372 0609082331 0609082333 0609079892 0506069872
0506069875 0601082091 0601082092 0607081892 0607081893 0512070332 0512070337
0604081037 0604081039 0512070333 0601083589 0502072058 0502072219 0504070085
0601083584 0609079893 0502072070 0404059009 0405060916 0406062857 0407058697
0511075672 0610079808 0612087522 0610079809 0505075450 0506070797 0506070799
0508081000 0509074722 0612087681 0612087685 0508080999 0509074952 0408066081
0411068040 0403059871 0403059875 0511075668 0511075670 0505075448 0506069874
0508081375 0508081376 0403060956 0312058058 0312058062 0309052388 0601082095
0509074723 0509074725 0402059070 0402060431 0402060433 0402060435 0502072217
0502072220 0405059703 0503071540 0504070055 0504070057 0504070060 0506070733
0610079810 0509074846 0403060959 0411068039 0606086093 0606086097 0310057034
0310057035 0606086091 0612080504 0603079025 0609082334 0610079806 0609079889
0609082335 0406061037 0409065507 0409065508 0409065509 0409065510 0409065530
0409065532 0409065534 0409067666 0502072216 0608080023 0608080025 0501072513
0501072514 0611079017 0611081316 0504070053 0607081884 0604081423 0605082514
0601083586 0601083588 0606087507 061108118