WEEK ENDING JUNE 2
PRODUCT All Clini-Kits and COBE Clinical Kits containing
Antiseptic Products recalled by Clinipad Corporation.
CODE All lot numbers of the following product codes manufactured
by GAMBRO Healthcare, 1990 Industrial Drive, DeLand, Florida, within the
last 3 years. All product codes begin with 014108 followed by: 0010C-0012C,
0014C, 0017C, 0019C-0021C, 0024C, 0025C, 0027C, 0028C, 0037C-0040C, 0043C-0045C,
0047C-0051Cl, 0053C, 0056C-0060C, 0062C, 0065C, 0066C, 0068C-0070C, 0072C,
0074C-0076C, 0079C-0083C, 0088C, 0091C-0095C, 0098C-0100C, 0102C, 0103C,
0105C, 0107C, 0109C, 0110C, 0111C, 0114C, 0115C, 0122C-0124C, 0126C, 0128C-0131C,
0133C-0135C, 0137C, 0145C, 0146C, 0150C-0153C, 0155C-0161C, 0164C, 0166C-0193C,
0201C-0203C, 0205C, 0208C, 0209C, 0211C, 0213C-0231C, 0233C-0236C, 0238C,
0240C-0250C, 0252C, 0253C, 0255C, 0257C-0259C, 0262C, 0264C, 0265C, 0268C-0271C,
0273C-0275C, 0278C-0288C, 0290C-0298C, 0300C, 0303C, 0306C, 0316C, 0318C,
0319C, 0323C, 0324C. All lot numbers of the following product codes manufactured
by COBE Renal Care de Mexico S.A. de C.V., Blvd Pacifico No. 10014, Parque
Industrial Pacifico, Tijuana B.C., 22480, Mexico, within the last three
years. All product codes begin with 014108 followed by: 0038C, 0065C, 0134C,
0135C, 0176C, 0179C, 0190C, 0191C, 0193C, 0252C, 0253C, 0274C, 0275C, 0294C-0297C,
0299C, 0300C.
MANFACTURER Gambro Renal Products, Lakewood, Colorado.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Nationwide, The Bahamas, Canada, Mexico
QUANTITY 91,411 kits were distributed.
REASON The antiseptic products may be contaminated with
bacteria.
PRODUCT Various Dialysis Kits containing antiseptic
products recalled by Clinipad Corporation.
CODE
Class I: HDA Corpus - Sub, Lot #21348; HDA Corpus - Hemo,
Lot # 21349; UCSF Renal - Hemo, Lot # 21333; Anderson - Hemo, Lot # 21310;
DCI Jackson, Lot # 21312 ;TEX - Hemo, Lot # 21311;TEX
- Cath, Lot # 21310; Santa CLA 15, Lot # 21374;Santa CLA 16. Lot # 21375;
Santa CLA 17, Lot # 21376;Western - NY, Lot # 21317; Augusta - Sub, Lot
# 21342;Augusta - Hemo, Lot # 21343 ;MEDCTRHOU - Sub, Lot # 21352;
Madera, Lot # 21338; Ochner/H, Lot # 21392;Elmhurst -
IN, Lot # 21344; Elmhurst - EXT, Lot # 21345;DCI - Atlanta - C, Lot # 21320;
Hattiesburg, Lot # 21319;
Class II: Clinipad Iodophor PVP, Povidone Iodine pad,
Code # 9153, Lot # 911636; Cliniswab Povidone-Iodine USP stick, Code #
1261,
Lot #914953.
MANFACTURER Lee Medical International, Inc., Harahan,
Louisiana.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Texas, Louisiana, Mississippi, Arkansas,
New York, California, South Carolina, Tennessee, Missouri, Virginia, Illinois,
Georgia.
QUANTITY Approximately 27,100 kits were distributed.
REASON Class I - Products may be contaminated with bacteria.
Class II - Kits contain Clinipad products labeled as
sterile for which Clinipad is unable to assure the sterility.
Recall has been classified as Class I and II: Kits for
which the firm was unable to identify the code and lot numbers of Clinipad
products- Class I. Kits identified as containing Clinipad Code Number 9153,
Lot Number 911636 and Code Number 1261, Lot Number 914953, for which the
sterility could not be assured - Class II.
PRODUCT Broswlow/Hinkle Kits containing Antiseptic
products recalled by Clinipad Corporation.
CODE Product Numbers: 7700BIO, 7700PIO, 7700RIO, 7700WIO,
7700YIO, 7730ALS, 7730IALS, 7730FLY, 7730RED, 7730BLU, 7730YEL, 7730PUR,
7730WHI, 7730MOD. Lot Numbers: (Products manufactured prior to 1998 are
expired.) Year 2000 Year 1999 Year 1998
A,B,C 001-073 001-365 U, V, W 001-365 D,E,M Example:
A004 Example: 265U Example: 116M.
MANFACTURER Vital Signs, Inc., Totowa, New Jersey.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 5,016 kits were distributed.
REASON The antiseptic products may be contaminated with
bacteria.
PRODUCT Various I.V. Starter and Hospital Administration
Kits containing Antiseptic products recalled by Clinipad Corporation: Brown
Co. I.V. Start Kit, Part #561098, 100 per case; Doctors/Mass I.V. Start
Kit, Part #561696, 100 per case; Hardin Memorial Hospital, O.B. Kit, Part
#561715, 8 per case; Marion Medical Center I.V. Start Kit, Part #561730,
100 per case; Toledo Hospital I.V. Start Kit, Part #561735, 50 per case;
Fostoria Hospital I.V. Start Kit, Part #461751, 100 per case; Bryan Infant
Kit, Part #561771, 20 per case; Promedica I.V. Start Kit, Part #561816,
100 per case; Pomerene I.V. Start Kit, Part #5610941, 100 per case; Wilson
Memorial Newborn, Part #562834, 12 per case; Surgery Center I.V. Start
Kit, Part #562836, 100 per case; Bixby Baby Kit, Part #562843, 12 per case;
Fulton Co. IV Start Kit, Part #568053, 100 per case; Tolfree Hospital,
Infant Kit, Part #568600, 10 per case; Adams County I.V. Start Kit, Part
#562041, 100 per case; Jefferson Memorial Newborn Kit, Part #568662, 8
per case; and Jefferson Memorial O.B. Kit, Part #568665, 10 per case.
CODE Uncoded. All kits containing Clinipad products are
subject to recall.
MANFACTURER Jones-Zylon Company, West Lafayette, Ohio.
COMPONENT MANFACTURER Clinipad Corporation, Charlotte,
North Carolina.
DISTRIBUTION Ohio, Missouri, Illinois, Michigan.
QUANTITY 1,500 kits were distributed.
REASON The antiseptic products may be contaminated with
bacteria.
PRODUCT Capillary Dispensers. (Capillary tube or
capillary blood collection tube), intended to be used by medical professionals
to collect blood from a patient and to dispense the blood into a test cartridge.
CODE Catalog Number 111400, Lot 1489.
MANFACTURER Drummond Scientific, Broomall, Pennsylvania.
RECALLED BY i-STAT Corporation, East Windsor, New Jersey
DISTRIBUTION Nationwide.
QUANTITY 1,067 units were distributed. (Each unit is
a container of 50 capillary dispensers).
REASON The device is subject to elevated potassium results
(a positive potassium bias of about 0.8mM) while testing capillary blood
samples.
PRODUCT Vennous Catheter Kits (central, percutaneous,
and single lumen) and One Arterial Kit containing PRODUCTs recalled by
Clinipad Corporation.
CODE Arrow PRODUCT Numbers: AI-06210-K, AI-07155-K, AJ-13122-F,
AJ-23122-F, AK-00370, AK-02903, AK-04018, AK-04020, AK-04020-C, AK-04120,
AK-04122, AK-04210, AK-04212, AK-04220, AK-04225, AK-04300, AK-04301, AK-04301-LF,
AK-04306, AK-04510, AK-04522, AK-04550, AK-04550-A, AK-05420-P, AK-05520-P,
AK-07803-AG, AK-07903-AG, AK-08800, AK-09800, AK-09800-A, AK-09802, AK-09802-A,
AK-09803, AK-09804, AK-09804-AG, AK-09805, AK-09806, AK-09806-A, AK-09807,
AK-09807-A, AK-09807-AG, AK-09810, AK-09810-C, AK-09810-S, AK-09813-T,
AK-09817-S, AK-09880, AK-09883-S, AK-09903-AG, AK-09903-S, AK-09903-TB,
AK-09907-S, AK-09908-S, AK-11802-F, AK-12122-F, AK-12122-H, AK-12123-F,
AK-12123-H, AK-12142-CF, AK-12142-F, AK-12402, AK-12702, AK-12703, AK-12703-B,
AK-12802, AK-14402, AK-14502, AK-14553, AK-14703, AK-14703-A, AK-14703-H,
AK-15122-F, AK-15122-H, AK-15123-F, AK15123-H, AK-15402, AK-155533, AK-15703,
AK-15703-A, AK-15703-B, AK-15703-H, AK-15703-I, AK-15703-LF, AK-15703-UAB,
AK-15703-V, AK-15802, AK-16402, AK-16553, AK-16702, AK-17702, AK-17702-LF,
AK-22122, AK-22122-F, AK-22123, AK-22123-F, AK-22402, AK-22502, AK-22702,
AK-22703, AK-22802, AK-22854, AK-24301, AK-24306, AK-24402, AK-24703, AK-24703-A,
AK-24703-B, AK-24854, AK25-25122, AK-25122-F, AK-25123, AK-25123-F, AK-25402,
AK-25502, AK-25553, AK-25703, AK-25703-A, AK-25703-B, AK-25703-I, AK-25703-LF,
AK-25703-UAB, AK-25802, AK-25854, AK-26553, AK-26702, AK-27702, AK-35703-A,
AK-35703-B, AM-09804, AM-12703, AU-22122-F, AU-23122-F, AU-25122-F, BH-09810-S,
BH-12702, BH-12802, BH-22802, BP-09800, BP-09800-R, BP-09800-X, BP-09805,
BT-09810, BU-15703, BU-25703, CB-04001, CH-04500, CH-09800, CH-09903-S,
CK-01000, CK01410, CK-04711, CM-09800, DG-09810-AG, DG-09810-S, DH-09806,
EN-00370, EU-09903-S, EU-12702, EU-12703, FS-04510, GH-22703-A, GH-24703-A,
GH-25703-A, GS-05052-MW, GS-22122-F, GU-04020, HF-04020, HH-09803, JH-04210,
JH-09903-S, JH-15703-B, JK-09802, JM-04120, JM-07903-AG, JM-24703, JM-25703-B,
JM-25854, LC-12702, LH-04000, LH-09883-S, LI-09807, LI-09807-R, LJ-09807-S,
LO-05801, LV-15703-A, ME-04018, ME-04020, MG-09903-S, MG-25703-A, MH-090800,
MH-09810-VKS, MH-22703, MK-02031-TW, MK-02041-T, MK-02051-T, MM-09803,
MM-09817-S, MM-09883, MM-24703, MM-24854, MW-09880, MS-02031-TW, MS-020401-T,
MS-02051-T, MZ-09883-S, NA-32703, NE-09805, NH-09803-B, NH-12703, NL-09903-S,
NF-09880, NR-07803-AG, NR-07903-AG, NR-09810-S, NR-09903-S, NR-12703, NR-22703,
NR-22802-B, NR-25854, NS-09803, OS-04510, PB-04000, PB-04001, PC-09903-S,
PC-14703-AC, PG-09810-S, PH-09805, PH-09806, PK-01351, PK-01351-TW, PK-01351-W,
PK-01451, PK-01451-S, PK-01451-T, PK-01451-TW, PK-01451-W, PK-01451-WS,
PK-01452, PK-01452-W, PK-01552, PK-01552-S, PK-01552-W, PK-01552-WS, PM-09903-K,
PR-05041, PR-05041-LW, PR-05041-T, PR-05052, PR-05052-LW, PR-05052-MW,
PR-07051-T, PR-07051-TLW, PR-07051-TMW, PS-01651, PS-01652, PS-01671, PS-09810-S,
RH-09801, RH-22703, RH-25703, RP-09883-S, RP-09903-S, RR-22854, RV-15703,
SB-09810-S, SB-09903-S, SE-09810-SSH-04306, SH-24306, SH-25703-A, SJ-07802,
SJ-09200, SJ-09805, SJ-12702, SK-04812, SL-04710, SL-09807, SL-22802, SM-01410,
SM-05503, SM-09802, SM-14703, SM-15703, SR-09907, SU-04300, SU-09903-S,
SV-09804, SV-12703, TA-09880, UA-09800, UC-09880-S, UP-04710, UP-09806,
UP-15703, UT-09880, VA-05502, VA-09802, VA-25703-B, WB-09810-S, WB-12702,
WC-09804, WH-09807, WH-09883-S, WH-14703, WJ-01000, YN-09903-S, YN-15703
& YN-15703-S.
MANFACTURER Arrow Intl., Inc., Reading, Pennsylvania.
COMPONENT MANFACTURER Clinipad Corporation, Charlotte,
North Carolina.
DISTRIBUTION Nationwide.
QUANTITY Undetermined.
REASON Kits contain Clinipad products (alcohol prep pads,
bezoin tinet swabssticks, povidone iodine prep pad, povidone iodine ointment,
and alcohol swabsticks) labeled as sterile for which Clinipad is unable
to assure their sterility
PRODUCT Power Wheelchairs: a) Power Tiger; b) P7E
with duel battery box upgrade only, c) 9M; d)Excel; e) PMC; d) Ranger II.
CODE Serial Numbers 93D through 99C.
MANFACTURER Invacare Corporation, Elyria, Ohio.
DISTRIBUTION Nationwide and international.
QUANTITY 77,408 units were distributed.
REASON Wheelchairs may catch fire due to improper wiring
harnes configuration.
PRODUCT Blood Collection Needle with Sheath, 21
GA. x 1" Needle, single use only, Sterile: Unless package is opened or
damaged.
CODE REORDER No. N-621. All lots of product packed in
green plastic pouches.
MANFACTURER North American Medical Products, Inc., Albany,
New York.
DISTRIBUTION New York, California, New Jersey, Massachusetts,
Canada.
QUANTITY 19,200 units were distributed.
REASON Package integrity - lack of assurance of sterility.
PRODUCT Various procedure trays containing including
the following:
Central Line Dressing, Midline/PICC Line Support, Subclavian
On/Off, Dressing Change, Nerve Block, VAD Access, General Purpose Instrument,
I.V. Start, Suture Removal, Ventriculostomy, Wound Care, Urethral/Foley
Catheter, Catheter Care, under the Medcare and 14 private labels: Medical
Marketing, Catalog #DK7-7178; Capital Medical Inc., Catalog #CMI-2001;
UHS?HCI St. Louis, Catalog #DF8-8047; Owens and Minor (Touro Infirmary-label),
Catalog #DP2-2161; Rockwell Medical, Catalog #RW-1020, 2011, 2100; Modern
HomeCare, Catalog #DK7-0312; Patients Choice (Hospice or SpectraCare label),
Catalog # DK7-7119 & IF9-9099; American Homepatient, Catalog #DK7-0444;
OptionCare (Corporate), Catalog #DN7-7099; Children's Hospital Medical
Center, Catalog #DP2-2052; Medtronic PS Medical, Catalog #46155.
CODE The recalled trays include approximately 68 different
catalog numbers and approximately 120 different lot numbers. (NOTE: If
necessarya complete of catalog numbers and lot numbers can be obtained
from the New England District Office Recall Coordinator).
MANFACTURER Medcare Medical Group, Inc., East Swanzey,
New Hampshire.
COMPONENT MANFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Nationwide.
QUANTITY 7,504 cases, containing a total of 244,022 units.
REASON Procedure kits contain recalled Clinipad antiseptic
products.
PRODUCT Castle Series 200 Steam Sterilizer (Powerclave),
intended for sterilizing medical devices for use in hospitals and health
care facilities: a)Castle Model 222: Gravity Steam Sterilizer, Double Door;
b) Castle Model 233: Vacuum Steam Sterilizer, Single
Door. Safety Alert #N-015/016-0.
CODE Serial #s range from 97A58318 thru 99M60565. The
first 3 characters represent the year and month. (A=January, etc.) The
last five numbers are consistent with pressure vessel identification. NOTE:
There are sterilizers within this serial number range that are NOT affected
by this field correction. However, those sterilizers have different model
numbers than those subject to this safety alert.
MANFACTURER Getinge/Castle, Inc., Rochester, New York.
DISTRIBUTION Nationwide and international.
QUANTITY 286 sterilizers were distributed.
REASON Sterilizer door opened during sterilization cycle
due to damaged door hook.
WEEK ENDING JUNE 9
PRODUCT Human Wrist Restraints, used in a hospital
setting to restrain the limbs of patients that may be a harm to themselves
or attendants: a) Connected Wrist Restraint, Catalog Numbers 2204 and 2205
b) Locking Synthetic Strap, Catalog Numbers 2212 and
2213.
CODE Serial Numbers: Julian Date 00006-000067 and Julian
Date 00006-000067.
MANUFACTURER J.T. Posey Company, Arcadia, California.
DISTRIBUTION Nationwide, Puerto Rico, France, The Netherlands.
QUANTITY a) 152 units; b) 4 units were distributed.
REASON The devices were manufactured with materials that
did not meet specifications.
PRODUCT Cordis French, Mutipacs, Primopacs, Propacs
and other modified Angio Catheters and certain Endovascular 6 Fr Supertorque
models: a) 6 Fr Supertorque; b) 6 French Supertorque Plus; c) 7 French
Supertorque Plus; d) 6 French Plus TL Diagnostic Catheters; e) Multipac
Kit (with preceding catheters); f) Propac Kit (with preceding catheters);
g) Primopac Kit(with preceding catheters); h) Modified Special Product
(with preceding catheters).
CODE All unexpired codes of the listed Cordis products
as listed above which include Model Numbers manufactured from 1997 to present
are under recall. Also 142 additional Endovascular catheters. In this case
ONLY the listed model AND LOT NUMBERS are under recall because these lots
contain recalled catheters. Endovascular 6Fr Supertorques:Standard Catalog
#'s, Lot #'s affected by recall
Item
Lot
Item
Lot
455611T S0199292
455611T S0799745
455611T R098299
455613E R0799884
455613S R0999428
455660D W1198082
455662 S1298554
455665 R0299589
Item
Lot Units
Item
Lot
Units
TS63810000HS E0198004
5 ST63810000SIM2
E0198025 20
520000 08876
E0198045 5
ST63810002SIM2 E0198054
60
520000 13228
E0199002 5
520000 09327
E0199012 5
520000 09327
E0199020 5
ST63810000SIM3 E0199021
10
520000 13228
E0199027 10
MODC18065
E0200005 10
ST63810002SIM2 E0298051
50 ST63810002SIM2
E0299019 15
MODC18065
E0300001 10
ST63810000SIM2 E0398031
20
520000 08876
E0398040 5
520000 13228
E0398041 5
520000 13228
E0398051 5
TS63810000HS
E0399002 20
ST63810000SIM3 E0399003
10 ST63810002SIM2
E0399009 20
ST63810000SIM3 E0498011
15 ST63810000SIM2
E0498020 5
ST63810002SIM2 E0499004
30 TS63810000HS
E0499017 15
520000 13764
E0597010 5
ST63810000SIM4 E0597015
30
ST63810000SIM3 E0597022
15 ST63810000SIM2
E0597061 10
520000 08876
E0597076 5
ST63810000SIM4 E0598041
5
520000 08876
E0697037 5
TS63810000HS
E0698013 5
520000 13764
E0698024 10
520000 13764
E0698028 5
ST63810000SIM2 E0698041
10 ST63810000SIM3
E0698061 5
MODC13764
E0699008 5
MODC18065
E0699020 10
ST63810000SIM2 E0797056
10 TS63810000HS
E0797109 20
520000 13228
E0798014 5
ST63810000SIM2 E0798026
5
ST63810000SIM2 E0798031
45 520000 09327
E0897034 15
TS63810000HS
E0897074 5
520000 13764
E0898008 5
ST63810002SIM2 E0898015
30 520000 13228
E0898034 5
TS63810000HS
E0997007 5
TS63810000HS
E0997010 5
520000 13764
E0997063 25
TS63810000HS
E0997064 10
520000 13228
E0998016
5 TS63810000HS
E0998017 10
520000 13764
E0998026
5 520000 08876
E0998032
5
ST63810000SIM1 E0998033
5 TS63810000HS
E0998034 10
520000 13764
E0998038 10
520000 09327
E1097005
5
ST63810000SIM3 E1097016
20 520000 09189
E1097035 20
TS63810000HS
E1097055
5 520000 13764
E1098005
5
ST63810000SIM3 E1098045
20 MODC18065
E1099003 10
MODC18065
E1099016 10
TS63810000HS
E1197028 25
TS63810000HS
E1198021 15
TS63810000HS
E1198025 10
520000 09189
E1198030
10 520000 09189
E1198035 10
520000 08876
E1198042
5 TS63810000HS
E1198043
5
ST63810000SIM2 E1297026
15 ST63810000SIM3
E1297036 10
520000 09327
E1298001
5 MODC18065
E1299004
10
MODC13052
K0100077
5 TS73808000C2
K0199004
5
TS73806500STR K0199096
5 MODC08876
K0200197
5
MODC17857
K0200274
10 MODC17857
K0200386
5
ST63812500SIM1 K0299238
5 ST63812500H1
K0299239
5
TS73806500STR K0299263
5 520000 17428
K0299266
40
TS73806500STR K0398145
10 TS73808000C2
K0398257
5
520000 17428
K0398312
10 TS73808000C2
K0398347
5
520000 17429
K0398358
10 520000 17417
K0498054
5
TS73808000C2
K0498238
5 TS73808000C2
K0498239
5
TS73808000C2
K0499006
20 ST63812500SIM1
K0499021
5
TS73808000C2
K0598040
5 MODC13052
K0599104
5
MODC17924
K0599186
5 MODC13052
K0599358
15
MODC12147
K0599482
10 ST63806502C3
K0698115
5
MODC12147
K0699112
10 MODC18045
K0699128
5
MODC18076
K0699340
5 MODC17857
K0699415
5
MODC17857
K0798249
25 MODC17857
K0799089
15
TS73808000C2 K0898159
5
TS73806500SIM2 K0898164
10
ST63806506STR K0898195
10 MODC17848
K0899310
20
MODC17428
K0899351
5 TS73808000C2
K0998213
5
ST63806502C2 K0998257
5 MODC17848
K0999152
20
MODC13052
K0999232
25 MODC17857
K0999422
15
TS63808000SIM2 K1097050
10
ST63806506STR K1098116
10
ST63806502C2 K1098117
5
520000 17428
K1098134
5
TS73808000C2 K1098262
5
MODC18328
K1099245
5
MODC08101
K1099430
45
TS73808000C2
K1198268
5
MODC18390
K1199326
5
MODC13052
K1199338
15
ST63810000VER K1298168
5
MODC08101
K1299065
5
MODC08101 K1299074 5.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 6,573 lots and 6,451,609 catheter units were
distributed since 1997.
REASON The catheters may have unexpected fibers in inner
lumen which may loosen into the blood.
PRODUCT CML, Inc. Kits and Trays for particular
medical procedures. Most of the kits and trays are custom products, manufactured
differently for individual customers:
CVC Dressing Change Kits, product number 02-138
CVC Dressing Change Trays, product numbers 1918, 02-004,
02-005, 02-008, 02-012, 02-014, 02-020, 02-021, 02-023, 02-026, 02-028,
02-029, 02-030, 02-034, 02-036, 02-039, 02-052, 02-105, 02-106, 02-122,
02-123, 02-130, 02-131, 02-133, 02-135, 02-140, 02-141, 02-143, 02-146,
02-148, 02-150, 02-152, 02-153, 02-154, 02-156, 02-158, 02-161, 02-162,
02-164, 02-165, 02-167, 02-168, 02-175, 02-176, 02-177, 02-178, 02-179,
02-185, 02-187, 02-402, 02-403, 02-423, 02-42B, 02-445, 02-610, 02-008A,
02-026A, 02-402B; 2006, 2025, 5050, 5062, 5068, 6010HP, 6010-2, 6011, 6012-1,
6013, 6016, 6017, 6018, 6019, 6021, 6022, 6028, 6029, 6030-1, 6033, 6036,
6037, 6038, 6042, 6046, 6048, 6051, 6052, 6053, 6059, 6063, 6066, 6067,
6071, 6072, 6076, 6077
Central Line Dressing Change Kits, product numbers 02-157,
02-159
PICC/Central Line Dressing Change Kit, product #02-183
Central Line Change Trays, product numbers 02-121, 02-145,
02-182, 4550
RJDT 2820 Central Line Dressing Change Tray
TPN Tray, product number 9002
TPN/CVP Dressing Change Kits, product nos. 02-001, 02-003
CVP/TPN Dressing Change Trays, product #6027
CVC/TPN Dressing Change Tray, product number 02-124
IMS CVC Dressing Change Tray, product number 02-169
Wausau VNA CVC Dressing Change Tray, product number 02-181
BMR-160 CVP Dressing Change Tray
HCA 02-402 CVC Dressing Change Tray
Dressing Change Kits, product number 01-160, 02-192,
02-198, 02-457, 2150
Dressing Change Kit with Island Dress, product #02-190
Dressing Change Trays, product numbers 01-162, 01-163,
02-032, 02-033, 02-134, 02-163, 02-180, 02-88, 2011, 2190DC, A371-83, 6065,
6079
Dress Change Hard Tray, product number 02-196
CD Dressing Change Kit, product number 2023
Amicare Dressing Change Tray, product number 5000
CD02121 Dressing Change Tray, product number D2133
RJ2133 Dressing Change Tray
SJH1000 Dressing Change Kit
St. Joseph's Dressing Change Tray, product number 02-184
VAD Access Kits, 02-050, 02-051, 02-053, 02-058, 02-116,
7020
VAD Insertion Trays, product numbers 02-114
Catheter Insertion Trays, product numbers 02-101, 02-102,
02-103, 02-112, 02-117, 6043
Catheter Insertion Kit, product number 02-115
PICC Tray, product number 6026
PICC Line Tray, product number 6020, 7022
PICC Dressing Tray, product number 60201
PICC Dressing Change Kits, product number 02-137
PICC Dressing Change Trays, product number 02-108, 02-109,
02-111, and 02-136
BMR145-1 PICC Line Tray
RJDT3555 PICC Line Tray, Latex-Free
Midline Kit, product number 02-274
Midline Trays, product numbers 02-221 and 02-270
Midline Insertion Trays, product numbers 02-271, 02-279
PICC Kit, product numbers 2062, 2064
PICC Midline Tray, product number 02-222
Midline Catheter Prep Tray, product number 7012
Midline Catheter Support Tray, product number 02-151
Midline Catheter Care Kit, product number 02-273
Peritoneal Kit, product number 02-189
Port Access Trays, product number 02-194
TPN Dressing Change Kits, product numbers 02-126, 02-191
TPN Dressing Change Trays, product numbers 02-128, 02-193
CVC/TPN Dressing Tray with Drape, product number 02-02T
CVC/TPN Dressing Change Tray, product number 02-124
C.V.P. Dressing Change Tray, product number D2133
CHM2500 Urethral Catheter Tray
CHM2500A Urethral Catheter Tray
Urethral Catheterization Tray, product number 3022015
CHM2000 Foley Insertion Kit
IV Start Kits, product numbers 01-147, 5056, 6008, 6080
Chow Change Tray, product number 02-425
Chow Dressing Change Tray, product number 02-025, 02-031,
02-427
Chow Dressing Change Kits, product numbers 1910, 02-431
RJDT2825 Chow Dressing Change Tray
IU Medium Dressing Change Trays, product numbers 02-037,
6068
Home Care Kit, product number 02-055
Home Care Kit with B-D Syringe, product number 02-054
SJH3000 Sub Q Port Kit
IV Dressing Change Kits, product numbers 5054, 6024
IV Dressing Change Tray, product number 02-110
Children Dressing Change Tray, product number 02-127
Option Care D.C. Kit, product number 02-197
Dialysis Dressing Change Tray, product number 02-223
Wound Care Tray, product number 2270
Deridement Tray, product number A37182
Oncology Tray, product number 6075
A1796L-1 Lesion Removal Pack
BB-27 Groshong Prep Kit.
CODE All lots of the products are to be checked for the
Clinipad swabsticks.
MANUFACTURER Continental Medical Laboratories, Inc.,
Waterford, Wisconsin.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hills,
Connecticut.
DISTRIBUTION Nationwide.
QUANTITY Approximately 2,000 kits.
REASON Kits contain Clinipad products labeled as sterile
for which Clilnipad is unable to assure the sterility.
PRODUCT Vas-Cath Hemodialysis Catheters (Opti-Flow,
Soft-Cell, Flexxicon, Flexxicon II, Trialysis, Vaccess, Niagara, and Hemofiltration.
CODE OPTI-FLOW PERMANENT DIALYSIS CATHETERS
Product Code Lot Number
5631190 - - - - 22KJ1419, 22LJX030
5631230 - - - - 22KJ1418, 22LJX016
5631690 - - - - 22BK1820, 22KJ1427, 22LJX033, 22LJX045
5631692 - - - - 22LJM011
5631730 - - - - 82EJ0111, 82GJ0007
5632190 - - - - 22KJ1426
5632192 - - - - 22KJ1407
5632230 - - - - 22LJM010
5632232 - - - - 22LJM012
5633190 - - - - 22KJ1425, 22LJX031, 82BJ0074, 82CJ0114,
82KJ0002
5633192 - - - - 82BJ0072, 82CJ0117
5633230 - - - - 22KJ1423, 22LJX017, 82CJ0116
5633232 - - - - 82BJ0073, 82JJ0009
5633690 - - - - 22KJ1431, 22LJM006, 82CJ0053, 82DJ0149,
82GJ0002
5633690 - - - - 82KJ0003
5633692 - - - - 22DJ0111, 22HJM707, 22HJM708, 22JJO758,
22KJM002, 82DJ0035, 82DJ0150, 82DJ0151, 82GJ0003, 82IJ0004, 82IJ0005, 82IJ0031,
82IJ0033, 82JJ0005
5633730 - - - - 22BK1823, 22IJM726, 22KJ1428, 22LJM007,
82BJ0075, 82EJ0112, 82GJ0006, 82HJ0007, 82JJ0008.
5633732 - - - - 22IJM734, 22LJM009, 22LJM016, 22LJM017,
82DJ0037, 82EJ0113, 82GJ0004, 82GJ0005.
5633732 - - - - 82IJ0006, 82IJ0007, 82JJ0007, 82JJ0008.
5634190 - - - - 22BK1822, 22KJ1430, 82DJ0034, 82EJ0109,
82EJ0110, 82FJ0004, 82GJ0008, 82GJ0009, 82HJ0011, 82KJ0001.
5634192 - - - - 22AKM021, 22AKM022, 22AKM024, 22BK1833,
22BK1834, 22BK1835, 22LJM005, 82CJ0054, 82DJ0036, 82EJ0043, 82EJ0044, 82HJ0002,
82HJ0003, 82IJ0001, 82IJ0002, 82IJ0003, 82JJ0001, 82JJ0002, 82JJ0003.
5634230 - - - - 82FJ0002, 82HJ0004, 82HJ0008.
5634232 - - - - 82CJ0055, 82FJ0003, 82HJ0005, 82HJ0006,
82HJ0009, 82HJ0010, 82IJ0008, 82IJ0030, 82JJ0033.
5635192 - - - - 36FJ0156.
5635232 - - - - 36BJ0130, 36DJ0208, 36DJ0212.
5635692 - - - - 36AK0036, 36BJ0131, 36CJ0184, 36DJ0206.
5635732 - - - - 36BJ0132, 36DJ0232, 36LJ0048.
5636192 - - - - 36AK0035, 36DJ0207, 82EJ0044.
5636232 - - - - 36BJ0130, 36DJ0208, 36LJ0066.
NIAGARA TEMPORARY DIALYSIS CATHETERS
5577121 - - - - 22AK1472, 22IJ0742, 22JJ0773, 82CJ0003,
82CJ0004.
5577202 - - - - 22BK1851, 22KJ1401, 82CJ0169, 82CJ0170.
5577224 - - - - 22AK1445, 22FJ0378, 22IJ0744, 22LJ1434,
22LJX044, 82CJ0008, 82CJ0168.
5678122 - - - - 22BK1825, 82CJ0002.
5678155 - - - - 22FJ0404, 22IJ0746, 22KJ0787, 22KJ0794,
82CJ0005, 82CJ0010, 82CJ0173.
5678202 - - - - 82CJ0006.
5591150 - - - - 22AK1441, 22FJ0400, 22IJ0740, 22JJ0774,
82CJ0167.
5591200 - - - - 22AK1477, 22BK1853, 22CJ0085, 22CJ0101,
22FJ0375, 22HJ0704, 22JJ0760, 22KJ0795, 22KJ1400, 22LJX026.
5591240 - - - - 22IJ0737.
5592120 - - - - 22BK2108, 22DJ0147.
5592150 - - - - 22AK1443, 22BK1847, 22CJ0080, 22DJ0157,
22FJ0401, 22HJ0702, 22IJ0745, 22JJ0759, 22JJ0776, 22LJX022.
5592200 - - - - 22AK1444, 22AK1484, 22AK1491, 22CJ0081,
22CJ0100, 22GJ0452, 22KJ0789, 22KJ0790, 82CJ0171.
5593150 - - - - 22AK1442, 22AK1809, 22BK1846, 22DJ0162,
22EJ0327, 22GJ0453, 22IJ0741, 22JJ0754, 22KJ1402, 22LJX004.
5593200 - - - - 22AK1808, 22BK1852, 22DJ0163, 22EJ0328,
22FJ0409, 22JJ0749, 22LJX027.
5593240 - - - - 22AK1812, 22DJ0161, 22FJ0377, 22IJ0738,
22KJ1414, 22LJ1435, 22LJX043.
5594120 - - - - 22AK1813, 22DJ0165, 22FJ0402, 22KJ1403,
22KJ1411.
5594150 - - - - 22BK1849, 22BK1850, 22FJ0403, 22IJ0747,
22JJ0777, 22KJ1408, 22LJX001, 82BJ0056.
5594200 - - - - 22AK1492, 22AK1814, 22FJ0405, 22GJ0454,
22KJ0791, 22LJX036.
5595150 - - - - 36AK0033, 36BJ0125, 36CJ0158, 36DJ0210,
36FJ0152, 36GJ0112, 36HJ0179, 36KJ0011, 36LJ0008.
5595200 - - - - 36AK0051, 36BJ0126, 36CJ0161, 36FJ0153,
36GJ0115, 36HJ0182, 36HJ0183, 36JJ0067, 36KJ0012, 36LJ0010, 36LJ0065.
5595240 - - - - 36BJ0127, 36CJ0159, 36GJ0113, 36HJ0180,
36KJ0014.
5596120 - - - - 36CJ0163, 36DJ0209, 36FJ0155, 36GJ0117,
36HJ0184, 36KJ0010, 36LJ0007.
5596150 - - - - 36AK0032, 36AK0050, 36BJ0128, 36CJ0160,
36DJ0210, 36GJ0114, 36HJ0181, 36LJ0009.
5596200 - - - - 36AK0034, 36BJ0129, 36CJ0162, 36DJ0211,
36FJ0154, 36GJ0116, 36HJ0183, 36KJ0013, 36LJ0011.
FLEXXICON II TEMPORARY DIALYSIS CATHETERS
5521150 - - - - 22AK1457, 22BJ0046, 22BK1827, 22BK2113,
22CJ0099, 22EJ0171, 22FJ0367, 22GJ0425, 22KJ1405.
5521200 - - - - 22AK1436, 22BJ0047, 22BK2103, 22EJ0172,
22EJ0348.
5521240 - - - - 22BJ0048, 22DJ0117, 22EJ0173, 22EJ0349.
5522120 - - - - 22CJ0055.
5522150 - - - - 22AK1454, 22BJ0028, 22BK1838, 22CJ0056,
22EJ0169, 22EJ0174, 22GJ0423, 22LJX023.
5522200 - - - - 22CJ0057, 22EJ0170, 22FJ0368, 22GJ0424,
22IJ0715, 22IJ0722, 22IJ0723.
5522650 - - - - 22BK2100.
5522700 - - - - 22DJ0129.
5523150 - - - - 22AK1468, 22BK1841, 22BK2114, 22CJ0069,
22CJ0098, 22EJ0179, 22FJ0384, 22GJ0432.
5523200 - - - - 22AK1437, 22BK2104, 22CJ0097, 22EJ0181,
22EJ0356.
5523240 - - - - 22CJ0068, 22EJ0183.
5524120 - - - - 22CJ0089, 22EJ0176.
5524150 - - - - 22BK1839, 22CJ0090, 22DJ0132.
5524200 - - - - 22DJ0131, 22LJX006, 82CJ0073.
5524620 - - - - 22EJ0175, 82CJ0056.
5524650 - - - - 22BK2101, 22BK2115, 22CJ0067, 22EJ0177,
22GJ0429.
5524700 - - - - 22BK1836, 22DJ0130, 22GJ0430, 82CJ0072.
5525150 - - - - 22DJ0136, 22DJ0137, 22EJ0187, 22FJ0410,
22LJX020.
5525200 - - - - 22DJ0138, 22DJ0139, 22EJ0311, 22EJ0313,
22GJ0436.
5525240 - - - - 22DJ0140, 22EJ0188, 22FJ0385, 82BJ0080.
5526120 - - - - 22DJ0141, 22EJ0186, 22GJ0434.
5526150 - - - - 22DJ0156, 22FJ0397, 82BJ0077.
5526200 - - - - 22DJ0155, 22FJ0398, 22GJ0435, 22LJX014,
82CJ0075.
5526650 - - - - 22DJ0148, 82BJ0076.
5526700 - - - - 82CJ0074.
5577105 - - - - 22BK2117, 22FJ0394.
5577115 - - - - 22BK1840, 22CJ0087, 22FJ0370, 82BJ0064.
5577135 - - - - 22CJ0058, 22EJ0178, 22FJ0396, 22GJ0431.
5577215 - - - - 22AK1458, 22CJ0063, 22EJ0180, 22FJ0372,
22KJ1406.
5577220 - - - - 22AK1439, 22BK2105, 22CJ0062, 22DJ0119,
22EJ0182, 22EJ0357, 22GJ0433.
5577324 - - - - 22AK1446, 22AK1453, 22AK1469, 22CJ0061,
22DJ0120, 22EJ0184, 22FJ0371, 22JJ0756, 22KJ0780, 22LJX007.
SOFT CELL PERMANENT DIALYSIS CATHETERS
5500100 - - - - 22CJ0070, 22KJ0796, 22LJX032.
5531120 - - - - 22BJ0008.
5531190 - - - - 22DJ0102.
5531230 - - - - 22BJ0010, 22FJ0412, 22IJ0711.
5531620 - - - - 22BJ0007, 22BK1815, 22FJ0379.
5531690 - - - - 22GJ0470.
5531730 - - - - 22AK1478, 22AK1496, 22CJ0083.
5532120 - - - - 22BJ0004.
5532190 - - - - 22DJ0103, 22EJ0196, 22FJ0366.
5532230 - - - - 22BJ0054
5533120 - - - - 22DJ0128, 22EJ0198.
5533190 - - - - 22BK1816, 22DJ0108, 22EJ0301, 22FJ0382,
22KJ0798.
5533230 - - - - 22AK1497, 22CJ0073, 22DJ0116, 22FJ0413,
22LJX041.
5533620 - - - - 22DJ0127.
5533690 - - - - 22AK1450, 22DJ0107, 22EJ0300, 22FJ0381,
22GJ0471.
5533730 - - - - 22DJ0110, 22FJ0383.
5534120 - - - - 22DJ0105, 22EJ0199, 22GJ0468.
5534190 - - - - 22AK1449, 22AK1479, 22BK1817, 22CJ0072,
22DJ0109, 22FJ0407.
5534230 - - - - 22CJ0071, 22DJ0111, 22FJ0414, 22LJX024,
82JJ0005.
5536190 - - - - 22DJ0145.
VACCESS SINGLE-LUMEN DIALYSIS CATHETERS
5541150 - - - - 22BJ0005, 22BK1832, 22EJ0307, 22EJ0345,
22GJ0426.
5541200 - - - - 22BJ0006, 22EJ0308, 22EJ0346, 82DJ0157.
5541650 - - - - 22EJ0309.
5541700 - - - - 22EJ0310, 22EJ0347, 82DJ0154, 82ADJ0155,
82DJ0156.
5542150 - - - - 22EJ0302, 22EJ0314, 22EJ0341.
5542240 - - - - 22CJ0082, 22DJ0123, 22EJ0304, 22EJ0343.
5542650 - - - - 22EJ0303, 22EJ0342, 22IJ0712, 22IJ0713,
22IJ0714.
5542700 - - - - 22AK1447, 22DJ0113, 22EJ0305.
5543150 - - - - 22DJ0152, 22EJ0320.
5543200 - - - - 22EJ0321.
5543650 - - - - 22DJ0114, 22EJ0322, 22EJ0354.
5543700 - - - - 22DJ0115, 22EJ0323, 82DJ0153.
5544150 - - - - 82BJ0081.
5544200 - - - - 22DJ0126, 22EJ0317, 22EJ0352.
5544650 - - - - 22DJ0125, 22EJ0315.
5544700 - - - - 22EJ0353.
5577250 - - - - 22GJ0442.
5577265 - - - - 22DJ0149.
5577270 - - - - 22DJ0158, 82DJ0152.
5577275 - - - - 22CJ0084.
HEMOFILTRATION CATHETERS
5573110 - - - - 22KJ1095, 82BJ0022, 82CJ0059, 82DJ0039.
MANUFACTURER Bard Access Systems, Salt Lake City, Utah.
DISTRIBUTION Nationwide and international.
QUANTITY 175,034 units were distributed.
REASON Cracked luer connectors which could cause air
embolisms or blood loss.
PRODUCT Cordis Savvy PTA Balloon Catheters:
Model: 435200L, 435200S, 435202L, 435202S, 435202T, 435202X,
435203L, 435203S, 435203X, 435204L, 435204S, 435204X, 435206L, 435206S,
435250L, 435250S, 435252L, 435252S, 435252X, 435253L, 435253S, 435253X,
435254L, 435254S, 435254X, 435256L, 435256S, 435300L, 435300S,
435302L, 435302S, 435302X, 435303L, 435303S, 435303X,
435304L, 435304S, 435304X, 435306L, 435306S, 435350L, 435350S, 435352L,
435352S, 435352X, 435353L, 435353S, 435353X, 435354L, 435354S, 435354X,
435356L, 435356S, 435499L, 435400S, 435402L, 435402S, 435402X, 435403L,
435403S, 435403X, 435404L, 435404S, 435404X, 435406L,
435406S, 435450L, 435450S, 435450Y, 435452L, 43542S, 435452Y, 435454L,
435454S, 435454Y, 435456L, 435456S, 435456Y, 435500L, 435500S, 435500Y,
435502L, 435502S, 435502Y, 435503L, 435503S, 435503Y, 435504L, 435504S,
435504Y, 435506L, 435506S, 435506Y, 435550L, 435550S,
435550Y, 435552L, 435552S, 435552Y, 435553L, 435553S, 435553Y, 435554L,
435554S, 435554Y, 435556L, 435556S, 435556Y, 435699L, 435600S, 435600X,
435600Y, 435602L, 435602S, 435602Y, 435603L, 435603S, 435603Y, 435604L,
435604S, 435604Y, 435606L, 435606S, 435606X, 435606Y.
CODE A total of 790 lots are involved which represents
all unexpired product produced from May 1998 to present.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
DISTRIBUTION Nationwide and international.
QUANTITY 790 lots or 11,550 units.
REASON Hub leakage during flushing of catheters because
of cracks.
PRODUCT Exacta External Drainage and Monitoring
System, used for externally draining cerebrospinal fluid (CSF) from the
lateral ventricles of the brain and monitoring intracranial pressure due
to head trauma.
CODE Catalog No. 46700, Lot Nos. R5651 through R5657,
R8515, R9255, R9581, R9938, T0419, T1262, T1974, T2528, T2645, T3237, T3515,
T4771, and T5140.
MANUFACTURER Medtronic PS Medical, Goleta, California.
DISTRIBUTION Nationwide and international.
QUANTITY 1,895 units were distributed.
REASON The device's sterility may be compromised due
to loss of package integrity and which may possibly allow bacteria to enter
the patient.
PRODUCT Pacesetter Trilogy Pulse Generator, indicted
for the treatment of bradycardia:
a) Trilogy SR 2250 Pulse Generator; b) Trilogy SR+ 2260
Pulse Generator; c) Trilogy SR+ 2264 Pulse Generator; d) Trilogy DC 2308
Pulse Generator; e) Trilogy DC+ 2318 Pulse Generator; f) Trilogy DR 2350
Pulse Generator; g) Trilogy DR+ 2360 Pulse Generator; h) Trilogy DR+ 2364
Pulse Generator.
CODE Serial Numbers:
53184-53232 ;53433-53478 ;53983-54032 ;54673-54722 ;55526-55572;
55873-55971; 56273-56422 ;58113-58205; 58966-59014 ;
59316-59372 ;59778-59822 ;61075-61122; 61433-61532 ;61633-61725;
62133-62182 ;63233-63281; 66851-66959; 66970-66994.
MANUFACTURER St. Jude Medical, Cardiac Rhythm Management
Division, Sylmar, California.
DISTRIBUTION Nationwide and international.
QUANTITY Approximately 144,000 generators.
REASON An anomaly with the microprocessor integrated
circuit was detected. The anomaly behavior includes: Interrogation/programming
difficulties, including the presence of dashes (---) on the programmer
screen for some parameter values after interrogation; Unexpected rate variations;
Abnormally high battery current drain; Mode change
PRODUCT Merge ExamWorks Video Units, used with
equipment for connecting diverse diagnostic imaging products: Model/Catalog
Numbers 006-04100-00, 006-04100-01, 006-04100-00S, 006-04100-01S, and 006-04100-02.
CODE All units shipped prior to March 30, 2000.
MANUFACTURER Merge Technologies, Inc., West Allis, Wisconsin.
DISTRIBUTION California, Connecticut, Indiana, Illinois,
Kansas, Minnesota, Missouri, Nebraska, Ohio, Oregon, Texas, Brazil, Denmark,
The Netherlands, Sweden.
QUANTITY 168 units were distributed.
REASON Warning label which limits product use was omitted
from the cable of the video units.
PRODUCT U-100 Insulin Single Use Syringes, 29 G
X 1/2 inch and U-100 Insulin Single Use Syringes, 28 G X 1/2 inch.
CODE Lot Number 990427 for the 28 gauge X 1 cc product
and Lot Number 990426 for the 29 gauge X 1 cc product
MANUFACTURER Medicore, Inc., Hialeah, Florida.
DISTRIBUTION New Jersey and Florida.
QUANTITY 100 cases (100 syringes per case) were distributed.
REASON Mislabeled volume on outer shelf cartons, device
package is correct.
PRODUCT Alycon Reagent Probe LN 05D44-01.
CODE None.
MANUFACTURER Abbott Laboratories, Inc., Diagnostics Division,
Irving, Texas.
DISTRIBUTION Nationwide, Japan, Puerto Rico.
QUANTITY 78 units were distributed.
REASON The box labeled as containing a Reagent Probe
actually contained an ISE probe.
WEEK ENDING JUNE 16
PRODUCT a) Bennett X-Ray Contour Mammography Systems,
Model numbers: M-CTR-2000, M-CTR-2000-3P, M-CTR-P, M-CTR-3P; b) Profile
Mammography Systems, Model numbers: M-PRO-2000, M-PRO2000-3P, M-PRO, diagnostic
X-ray devices used in mammography.
CODE None
MANUFACTURER Bennett X-ray Corporation, Danbury, Connecticut.
RECALLED BY Trex Medical Corporation, Danbury, Connecticut
DISTRIBUTION Nationwide.
QUANTITY 607 units were distributed.
REASON The units are noncompliant with 21 CFR 1020.31(m)
in that the transmission limit 5-cm beyond the plane of the image receptor
support device exceeds 0.1 mR per exposure. This can result in the patient
receiving unnecessary exposure.
PRODUCT Model Gallium Elite and Midi Laser System,
for use in pain therapy for animals.
CODE None.
MANUFACTURER Sim-Med Ltd., United Kingdom.
DISTRIBUTION Florida, Alaska.
QUANTITY 3 units of each model were distributed.
REASON The device failed to comply with 21 CFR 1010.2,
1010.3, and 1040.10 (f) (6) (i) in that the products lack required certification
and identification and compliance with the beam attenuator requirement.
PRODUCT Vacutainer Brand Evacuated Blood Container,
partial draw sodium citrate tubes.
CODE Catalog Numbers: 369711, 369700, 367712, 367703,
367715, 366416, 369705, 367707, 366419.
MANUFACTURER Becton Dickinson & Co., Broken Bow,
Nebraska.
RECALLED BY Becton Dickinson & Company, Franklin
Lakes, New Jersey
DISTRIBUTION Nationwide.
QUANTITY Not applicable.
REASON Increased platelet activation in partial draw
tubes.
PRODUCT Procedure Tray, Fixture Installation, Catalog
#25369, dental handpiece and accessories.
CODE Lot numbers: 802899, 803109, 803183, 803237, and
803711.
MANUFACTURER Nobel BioCare AB, Gothenburg, Sweden.
RECALLED BY Nobel BioCare USA Inc., Yorba Linda, California.
DISTRIBUTION Alaska, Alabama, Arizona, California, Iowa,
Massachusetts, Michigan, Minnesota, Oregon, Nebraska, New Hampshire, New
Jersey, New York, Pennsylvania, Texas, Virginia, Washington state, Wisconsin,
Canada, Chile, Colombia.
QUANTITY 77 units were distributed.
REASON The spring on the connector to the contra-angle
handpiece may fracture and come loose.
PRODUCT Accurus 200PS Phacoemusification System,
Catalog #8065740742, a phacoemulsification system used for opthalmic surgery
featuring phacoemulsification, irrigation and aspiration capability, anterior
vitrectomy, and diathermy functions
CODE SERIAL NUMBERS:
9901725601X, 9902087501X, 9901446301X, 9901725501X, 9901890101X,
9901718101X, 0001038201X, 0001038101X, 0001065601X, 9901462801X, 9901725401X,
9901463001X, 9901463101X, 9901463201X, 9901467201X, 9901707301X, 9901707401X,
9901462901X, 9901717901X, 0001005201X,
9901442401X, 9901467001X, 9901718001X, 9902003301X, 0001005101X,
0001135901X, 9901446401X, 9901446501X, 9901446601X, 9901466901X, 9901467101X,
0001005401X, 0001005301X, 9901462701X, 0001136001X, 9801357001X.
MANUFACTURER Alcon Laboratories, Inc., Irvine, California.
RECALLED BY Alcon Laboratories Inc., also known as Alcon
Research LTD, Fort Worth Texas, (responsible firm)
DISTRIBUTION Florida, Maine, New Mexico, Virginia, Vermont,
Australia, Germany, Italy, France.
QUANTITY 33 units were distributed.
REASON The low pressure air output (AVGFI) module used
with the Alcon Accurus 200PS may unexpectedly drop to a low setting, resulting
in low irrigation or infusion pressure during surgery, while vacuum remains
active.
PRODUCT Dexter-ZII Blood Glucose Meter, intended
for use in self-monitoring of blood glucose by persons with diabetes:a)
Model 3958K2; b) Model 3958N2; c) Model 3969N2.
CODE Serial Numbers:
4000114, 4000162, 4000197, 4000330, 4001008, 4001047,
4001072, 4001118, 4001157, 4001178, 4001185, 4001191, 4001199, 4001200,
4001201, 4001215, 4001409, 4001514, 4001833, 4002475, 4002487, 4002569,
4002578, 4003218, 4003303, 4003329, 4003367, 4003443, 4003523, 4004102,
4004110, 4004112, 4004116, 4004129, 4004139, 4004158,
4004264, 4004273, 4004274, 4004278, 4004280, 4004283, 4004284, 4004298,
4004301,
4004303, 4004308, 4004500, 4004502, 4004505, 4004506,
4004511, 4004517, 4004518, 4004521, 4004526, 4004530, 4005010, 4005011,
4005050,
4005068, 4005322, 4005329, 4005359.
MANUFACTURER Bayer Corporation, Business Group Diagnostics,
Mishawaka, Indiana.
RECALLED BY Bayer Corporation, Elkhart, Indiana
DISTRIBUTION Japan.
QUANTITY 64 units were distributed.
REASON The systems begin to count down prior to the inoculation
of the reagent sensor.
WEEK ENDING JUNE 23
PRODUCT Peripherally Inserted Central Venous Catheter
Trays containing Clinipad Cliniguard Protective Dressing Prep.
CODE Catalog number C-PICS-301. Lot F804662
Catalog number C-PICS-301-CHOP-103097. Lot F790253.
Catalog number C-PICS-301J. Lots F833591, 952989, 955791,
950762, 952988, 959369, 950763, 824639, F794489, F796661, F801539, F806269,
F811737, F817595, F809235, F822207, F826239, F834114, F839371, F838672,
F840052 and F838672X.
Catalog number C-PICS-301J-SACRED-HEART-062591-PKG. Lots
F771187 and F791507.
Catalog number C-PICS-301J-UTAH-070992. Lots 947003,
947002, 951258, 951257, 956120, 956121 and 956892.
Catalog number C-PICS-401. Lots 956894 and 960721.
Catalog number C-PICS-401-CHOP-103097. Lots F794621,
F793680, F801365, F02215 and F806310.
Catalog number C-PICS-401J. Lots 949398, 955792, 949401,
956606, 956607, 956608, 949400, 960481, 948053, 955793, 955795, 932069X,
955794, 949399, 960482, F789187, F796784, F797974, F801540, F806623, F806270,
F810223, F816240, F819630, F822721, F824841, F826240, F833302, F791829,
F810408 and F828140.
Catalog number C-PICS-401J-JGH-121698. Lots F794145,
F809021 and F811276.
Catalog number C-PICS-401J-SACRED-HEART-062591-PKG. Lots
F784415, F801146, F800823, F818856 and F833973.
Catalog number C-PICS-401J-UTAH-070992. Lots 951914,
945532, 949403, 951915, 932792X, 956896, 957631, 956895, 956123, 956122
and 945530
Catalog number C-PICS-401J-X. Lot F811185.
Catalog number C-PICS-501. Lots F794146, F810409, and
F828141.
Catalog number C-PICS-501-ANDREWS-021191. Lots F804082
and F830783.
Catalog number C-PICS-501E-MCCREADY-041994. Lot F797212.
Catalog number C-PICS-501J. Lots F791623, F827945, 959620,
957447, 945802, 959618, 950481, 959621, 950482, F789188, F790483, F794490,
F796662, F796785, F799725, F801541, F802192, F806271, F810986, F817596,
F819631, F820587, F821289, F826998, F822208, F834115, F839372, F840053,
957446, F810410, F828142, and 945801.
Catalog number C-PICS-501J-ST-MARK-060391. Lot F792267.
Catalog number C-PICS-501J-UTAH-070992. Lots F833885,
F833992, F832109, F800450, F803795, F81222, F801538, F834317, and F805245.
Catalog number C-PICSY-301J-RP-011195. Lots 947305 and954515
Catalog number C-PICSY-401J. Lots 952430, 952431, 955796,
956899, 954222, 954223, 955797, 963886, 958901, and 956901.
Catalog number PICS-301-MPIS. Lots 956622, 954243, 954241,
958626, 958628, 958627, 943780, 951932, 951933, 956621, 954242, 957849,
956623, 954244X, 957850, 951930X, 943781, 957851, 960528, 957848, 960529,
958625, 954244 and 932824
Catalog number PICS-301-MPIS-A. Lots 952696, 95049,7
950498, 958629, 940831X, 942163, 942164, 958630, 960216, 960215, 958631
and 936028.
Catalog number PICS-301-MPIS-CMC-072899. Lot F794588.
Catalog number PICS-301-MPIS-NT. Lots F811680, F807565,
F823367, F834675, F823631, F788865, and F815245.
Catalog number PICS-301-MPIS-WOC. Lots 953050, 953051,
954930, 959895, 954931, 947316, 944002, 947314, 945820 and 959897
Catalog number PICS-301-MPIS-WOC-NT. Lots F796253, F808401,
F793351, F797779, F803200, F808243, F814403, F804945 and F831196
Catalog number PICS-401-MPIS. Lots 951935, 949429, 953673,
953682, 957860, 959652, 951938, 953674, 953676, 956955, 957857, 959654,
959658, 961686, 951944, 956962, 957853, 959655, 959659, 942533X, 953679,
956961, 953680, 951936, 951937, 951947, 953678, 953677, 956960, 956959,
957854, 956958, 959656, 951939, 951940, 953676X, 956956, 959657, 956954,
956957, 951943, 957855, 957856, 951944X, 957852, 951942, 951941, 951945,
953681, 957859, 957858, 953671, 961692, 961689, 953672, 951946, 953675,
F796338, 959653, 961690, F790506, F793794, F797481, F794509, F798001, F799742,
F801563, F806294, F816278, F809247, F819660, F820610, F822748, F824879,
F831102, F840130, F809671 and F828982.
Catalog number PICS-401-MPIS-A. Lots F818826, F832821
and F786275
Catalog number PICS-401-MPIS-A-NT. Lot F784799.
Catalog number PICS-401-MPIS-NT. Lots 953369, 955847,
965127, 960219, 958632, 960217, 958633, 960218, 963916, 962112, 966520,
962111, 953368, 963917, 956427, 953367, 948897, 965128, 955846, 955845,
956428, 966521, F819556 and 948896.
Catalog number PICS-401-MPIS-WOC. Lots F803427, F821904,
F841997, 958105, 952170, 953684, 961442, 948125X, 959388, 952169, 948125,
953683, 963918, 961441, 958106, 952169X, 959387, F790507, F822529, F824880
and F828983.
Catalog number PICS-401-MPIS-WOC-NT. Lots 953052, 962113,
958108, 957467, 958107, 957468, 956151, 950097, 950096, 962114, 956152,
953053, 959898, 959899 and 957469.
Catalog number PICS-501-ANDREWS-021191. Lot F817156.
Catalog number PICS-501-MNP-ABMH-071895. Lots F786365,
F822816, and F822816X.
Catalog number PICS-501-MPIS. Lots F799511, F799557,
F804730, 953083, 953063X, 956432, 956435, 956430, 950830, 955197, 955201,
950826, 950819, 959394, 959395, 959401, 953067, 953062, 953059, 955186,
955177, 956446, 959406, 950832, 953071, 953077, 955172, 956441, 957879,
959391, 957886, 959402, 956447X, 955194, 956437, 961449, 959412, 956436,
956440, 956438, 956442, 956448, 957864, 959396, 959408, 953058, 961460,
953075, 953055, 953068, 953073, 959399, 956445, 963065, 963068, 950818,
956429, 961453, 948931X, 948926X, 950806, 953081, 959409, 950822, 950825,
950831, 953082, 957869, 957870, 959407, 959398, 950833, 959393, 959400,
961462, 961465, 953061, 955202, 955195, 961464, 961459, 953079, 956433,
955184, 955176, 961446, 961444, 961445, 959404, 956447, 955178, 955188,
950824, 955171, 953078, 953063, 956452, 956449, 963083, 963072, 957876,
955196, 957874, 957886, 953084, 953072, 956451, 950817, 953056, 953060,
961452, 961451, 957862, 959397, 961455, 961461, 961463, 953085, 963086,
956450, 955179, 956431, 956444, 957863, 957884, 957880, 957882, 953066,
963084, 950821, 953073X, 963070, 955175, 963078, 955182, 950804, 957875,
955172X, F790508, F794510, F799743, F807506, F809248, F819687, F831103,
F836367, F840131, 961454, 961456, 953080, F794069, F809672, F808803, F828984,
950811, 950808, 959410, 957861X, 961448, 957877, 956431X, 955190, 957867,
963067, 950816X, 956453, 953080X and 953081X.
Catalog number PICS-501-MPIS-A. Lots 957198, 938781,
950836, 957199, 955849, 955848, 959167, 950835 and 950814.
Catalog number PICS-501-MPIS-MSH-091098. Lot F0802114.
Catalog number PICS-501-MPIS-NT. Lots 950851, 953089,
953093, 953097, 958645, 953094, 953099, 956966, 956963, 956974, 96972,
959672, 959662, 961103, 962121, 961110, 95494B, 958637, 961106, 953098,
954933, 954934, 954935, 959663, 961111, 954946, 956968, 959670, 961105,
961108X, 961102, 958641, 958644, 959668, 959666, 958634, 956970, 958638,
958640, 962115, 959671, 954942, 961108, 959669, 954947, 956973, 953086,
953088, 950838, 950839, 950846, 950848, 950849, 956969, 956975, 956976,
954939, 956965, 956967, 962123, 962118, 962122, 962125, 954938, 961104,
950852, 959661,
961100, 954944, 958635, 961107, 963642, 954940, 961101,
958639, 953087, 959665, 9533096, 954945, 962117, 962120, 963638, 953091,
961109, 958642, 953095, 953100, 954937, F789125, 953090, 950845, 956977,
953092, 954936, 958643, 956964, 959667, 956971, F796337, 950847, 954943,
948603, F819555, 954950, 961112, 954941, 954932, 958636, 953099X, 954949,
959670X, 959664, 959661X, 962116 and 950844.
Catalog number PICS-501-NT-MCLELLAN. Lot F793031.
Catalog number PICS-501-MPIS-NT-PGHC-122396. Lots F832007
and F827711.
Catalog number PICS-501-MPIS-ON. Lot F801842.
Catalog number PICS-501-MPIS-WOC. Lots 959674, 951641,
951642, 951644, 954248, 954245, 954246, 958111, 959673, 958112, 948623,
951645, 959676, 954247, 951639, 951643, 958110, 959675, 948617, 954249,
951640, 948622, 929837X, 933160X, 958109, F790509, F788527, F815515, F822749,
F834890, F796429, F809673 and F828985.
Catalog number PICS-501-MPIS-WOC-NT. Lots 957887, 956625,
952439, 952441, 954951, 957889, 952442, 952440, 948625, 960221, 955852,
955851, 960220, 955853, 956626, 957888, 956624, 960220X, F796693, F820611,
F840132 and 960222.
Catalog number PICS-ST-VINCENT-040593. Lots F828118 and
F829634.
Catalog number PICS-401-MPIS. Lots 946700, 950499, 957890,
957891, 959900, 963332 and 959901.
Catalog number PICSY-501-MPIS. Lots 950502, 951948, 954955,
951949, 954250, 956978, 956979, 954251, 954956, 950501 and 958646.
These products are packaged with Clinipad CLINIGUARD,
Protective, Dressing, Prep, 1, Prep, Pad-Clinipad, Reorder Code 8133S-B,
HK8133S. Lot number 914358 [Contains: Isopropyl, Alcohol, 79%, Butyl, Mono,
Ester, Dimetyl, Phthalate].
MANUFACTURER Cook Inc., Bloomington, Indiana (tray);
Venetec International, Inc., San Diego, California (stalock anchoring device)
RECALLED BY Cook, Inc., Bloomington, Indiana
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 21,520 Cook kits were distributed.
REASON Kits/trays contain Clinipad products labeled as
sterile for which Clinipad is unable to assure the sterility.
PRODUCT Osteonics Scorpio Posteriorly Stabilized
Total Knee:
a) Catalog Number: 71-5105L; b) Catalog Number: 71-5105R
c) Catalog Number: 71-5107L; d) Catalog Number: 71-5107R
e) Catalog Number: 71-5109L; f) Catalog Number: 71-5109R
g) Catalog Number: 71-5111L; h) Catalog Number: 71-5111R
i) Catalog Number: 71-5113L.
CODE a) Case Codes: K00A257, K00A87, K00A88, K99W347,
K99W348, K99W349, K99W459, K99W460
b) Case Codes: K00A258, K00A89, K00A90, K99W461
c) Case Codes: K00A91, K00A92, K00A93, K99W462, K99W463,
K99W464,K99W89
d) Case Codes: K00A262, K00A94, K00A95, K00A96, K00A97,
K99S246, K99W465, K99W467, K99W468, K99W469, K99W607
e) Case Codes: K00A100, K00A500, K00A98, K00A99, K99W472,
K99W471, K99W783
f) Case Codes: K00A101, K00A102, K00A103, K00A265, K99W188,
K99W474, K99W475, K99W477, K99W610
g) Case Codes: K00A429, K99W193, K99W749, K99W750, K99W751
h) Case Codes: K99W196, K99W197, K99W753, K99W754
i) Case Code: K99W198.
MANUFACTURER Howmedica Osteonics Corporation, Allendale,
New Jersey.
DISTRIBUTION Nationwide and international.
QUANTITY 10 units were distributed.
REASON Product labeling has additional line stating "All
Polyethylene" below the product name.
PRODUCT Amplified Mycobacterium Tuberculosis, in-vitro
diagnostic test kit:
a) Part No. 301001, Lot Nos. 909399, 911170, 911172,
Exp. Date 08/02/00;
INTERNATIONAL KITS:
b) Part No. 301001E, Lot Nos. 909400, 909410, 912246,
Exp. Date 08/02/00;
c) Part No. 301001F, Lot Nos. 909352, 912294, Exp. Date
08/02/00;
d) Part No. 301002J, Lot Nos. 909135 Exp. Date 02/23/00,
909254 Exp. Date 03/18/00, 910352 Exp. Date 04/11/00; Part No. 301011J,
Lot Nos. 909136 Exp. Date 02/23/00, 909255 Exp. Date 03/18/00, 910353 Exp.
Date 04/11/00;
CODE Domestic: a) Lot Nos. 909399, 911170, 911172, Exp.
Date 08/02/00;
INTERNATIONAL KITS: b) Lot Nos. 909400, 909410, 912246,
Exp. Date 08/02/00; c) Lot Nos. 909352, 912294, Exp. Date 08/02/00; d)
Lot Nos. 909135 Exp. Date 02/23/00, 909254 Exp. Date 03/18/00, 910352 Exp.
Date 04/11/00 (Part #301002J); Lot Nos. 909136 Exp. Date 02/23/00, 909255
Exp. Date 03/18/00, 910353 Exp. Date 04/11/00 (Part No. 301011J).
MANUFACTURER Gen-Probe, Inc., San Diego, California.
DISTRIBUTION Nationwide, Puerto Rico, Switzerland, Canada.
QUANTITY 1,414 kits were distributed.
REASON The above reagent experienced a reduced shelf
life after being reconstituted. The reduced shelf life may result in inadequate
amplification of some specimens during a test run. Inadequate amplification
may produce false negative results.
PRODUCT DeVilbiss Portable Ultrasonic Nebulizer
DC Power Cord.
CODE Catalog #5500D-616.
MANUFACTURER Sunrise Medical HHG, Inc., Somerset, Pennsylvania.
DISTRIBUTION Nationwide and Canada.
QUANTITY 370 units.
REASON The wrong DC power cord was supplied with the
nebulizer.
WEEK ENDING JUNE 30
PRODUCT MemoryLens Ultraviolet-Absorbing, Hydrophilic,
Posterior Chamber Lens: a) Model No. U940A, MemoryLens Ultraviolet-Absorbing,
Hydrophilic, Posterior Chamber Intraocular; b) Model No. U940S, MemoryLens
Ultraviolet-Absorbing, Hydrophilic, Posterior Chamber Intraocular Lens.
CODE All Lot Numbers manufactured on or before 3/24/2000.
MANUFACTURER Ciba Vision Corporation, Duluth, Georgia.
QUANTITY 263,000 units were distributed.
REASON Implantation of this lens may cause postoperative
inflammation.
PRODUCT T-9 Scoop Transtracheal Procedure Tray.
CODE Lot Numbers: 0339, 1409, 2749.
MANUFACTURER Transtracheal Systems, Englewood, Colorado.
COMPONENT MANUFACTURER Clinipad Corporation, Rocky Hill,
Connecticut.
DISTRIBUTION Nationwide and international.
QUANTITY 643 trays.
REASON Trays contain Clinipad products labeled as sterile
for which Clinipad is unable to assure the sterility.
PRODUCT SYSMEX CA-1000 and SYSMEX CA-5000 Automated
Coagulation Analyzer, used to the clotting times of heparinized patients
to adjust their heparin treatment.
CODE All serial numbers.
MANUFACTURER Sysmex Corp., Kobe, Japan
RECALLED BY Sysmex Corporation of America, Long Grove,
Illinois.
DISTRIBUTION Nationwide and international.
QUANTITY 1,405 CA-1000 analyzers and 132 CA-5000 analyzers
were distributed.
REASON Incorrect aPTT (activated partial thromboplastin
time) analysis of patient Samples which contain elevated levels of fibrinogen
or fibrinogen-related products which are not measured by aPTT (fibrinogen
monomer) could occur.
PRODUCT Walkmed Administration Sets for WalkMed
Infusion Pumps:
a) Catalog #PS-400/300; b) Catalog #EFV-101S; c) Catalog
#EFV-101B; d) Catalog #FPS-560.
CODE Lot Numbers: a) Lot 9I112, 9I113, 9J115, 9K103;
b) D991020-B; c) D991027-A; d) D991202-A.
MANUFACTURER McKinley Medical, LLLP, Wheat Ridge, Colorado.
DISTRIBUTION Nationwide and international.
QUANTITY 41,720 sets were distributed.
REASON Defective plastic elbow connector could allow
leak or air introduction.
PRODUCT Curity Spinal Anesthesia Tray; Safe Tap
Spinal Anesthesia Tray; Spinal Anesthesia; Saddle Block and Customer Special
Spinal Tray.
CODE Note: This recall only applies to alpha numeric
lot numbers beginning with "FE83", "HE83", "JE83" and "GE83"; numerical
lot numbers beginning with "0", "4", "5" and "9".
Part # Description
470 CURITY Spinal Anesthesia Tray
4716 CURITY Spinal Anesthesia Tray
4720 CURITY Spinal Anesthesia Tray
4722 CURITY Spinal Anesthesia Tray
4724 CURITY Spinal Anesthesia Tray
4727 CURITY Spinal Anesthesia Tray
4730 CURITY Spinal Anesthesia Tray
4731 CURITY Spinal Anesthesia Tray
4747 Safe Tap Spinal Anesthesia Tray
4748 Safe Tap Spinal Anesthesia Tray
4749 Safe Tap Spinal Anesthesia Tray
4760 CURITY Spinal Anesthesia Tray/Saddle Block
4761 CURITY Spinal Anesthesia Tray
4762 CURITY Spinal Anesthesia Tray
4763 CURITY Spinal Anesthesia Tray/Saddle Block
4764 CURITY Spinal Anesthesia Tray/Saddle Block
4765 CURITY Spinal Anesthesia Tray
4766 CURITY Spinal Anesthesia Tray
4767 CURITY Spinal Anesthesia Tray/Saddle Block
4768 CURITY Spinal Anesthesia Tray
4769 CURITY Spinal Anesthesia Tray
4770 CURITY Spinal Anesthesia Tray
4787 CURITY Spinal Anesthesia Tray/Saddle Block
4795 CURITY Spinal Anesthesia Tray/Saddle Block
4815 CURITY Spinal Anesthesia Tray
4920 CURITY Spinal Anesthesia Tray
5171 Continuous Epidural Anesthesia Tray
10569 Customer Special: Spinal Tray
10584 Customer Special: Spinal Tray
10590 Customer Special: Spinal Tray
10614 Customer Special: Spinal Tray
10616 Customer Special: Spinal Tray
10617 Customer Special: Spinal Tray
10618 Customer Special: Spinal Tray
10641 Customer Special: Spinal Tray
10702 Customer Special: Spinal Tray
10705 Customer Special: Spinal Tray
10708 Customer Special: Spinal Tray
472867 Customer Special: Spinal Tray
476827 Customer Special: Spinal Tray.
MANUFACTURER The Kendall Company LP, Mansfield, Massachusetts.
DISTRIBUTION Nationwide, Japan, Panama, Bahamas, Saudi
Arabia.
QUANTITY Approximately 14,570 cases.
REASON Spinal anesthesia trays contain recalled Epinephrine
Injection USP, 1 ml ampule.
PRODUCT Vasoview Dissection/Vessel Harvesting System:
a) VasoView, Part #09331; b) Vasoview Uniport, Part #11344; c) Vasoview
Uniport Plus, Part #11346. The VasoView Uniport dissection cannula has
applications in minimally invasive surgery allowing access for vessel harvesting,
and is primarily indicated for patients undergoing endoscopic vessel harvesting
surgery for arterial bypass.
CODE All codes.
MANUFACTURER Guidant Corporation, Menlo Park, California.
DISTRIBUTION Nationwide and international.
QUANTITY 5,730 units were distributed.
REASON Sterility may be compromised as evidenced by a
loss of package integrity.
PRODUCT Version 6A and prior versions of software
for Marquette Coherent Digital Telemetry (CDT) LAN Monitoring Systems,
a patient monitoring system designed to collect and transmit ECG and other
physiological data from ambulatory patients, without the patient being
physically connected to a display device.
CODE All versions of the software used with CDT LAN Monitoring
Systems.
MANUFACTURER GE Marquette Medical Systems, Inc., Milwaukee,
Wisconsin.
DISTRIBUTION Nationwide and international.
QUANTITY 2,254 units were distributed.
REASON Due to a software defect, there could be alarm
failure.
PRODUCT Fixer Image Scan Editing Utility, Version
3.0, intended to allow the user to remove suprious image slices from a
scan.
CODE Fixer Software Utility Version 3.0
MANUFACTURER Radionics, Inc., Burlington, Massachusetts.
DISTRIBUTION Nationwide and international.
QUANTITY 33 installed bases.
REASON Fixer 3.0 may provide inconsistent results if
a file is changed and saved twice in the same session.
PRODUCT Sarita and Sarita 160 Patient Lift, Non-AC
Powered Lift/Transfer System used to transfer patients/residents between
beds, chairs and toilets: a) Model KKA0400; b) KKA0420-16; c) KKA0401;
d) KKB3000-11US; e) KKB3020-16US.
CODE All serial numbers prior to 4899 834795-011 Model
KKB3000-11US - Sarita; Model KKB3020-16US - Sarita 160.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 967 units were distributed.
REASON Premature cracking of foot support platform of
the lift.
PRODUCT Maxilift Patient Lift, Non-AC powered,
used to move patients in a nursing home situation.
CODE All serial numbers preceding week 1/95, with serial
number prefixes preceding US0195, SE0195, GB0195, and include serial numbers
beginning with 93MM, 93ME, 94MM and 94ME.
Model 211026, Maxilift Manual Chassis with Scale
Model 212624, Maxilift Manual Chassis - Beige
Model 210024-06, Maxi Scale Std - Beige
Model 212000-06, Maxi Pillar Beige
Model KMB0810-06US, Maxilift Combi
Model KMB0830-06US, Maxilift Combi with Scale
Model KMB2351, Maxilift Electric with Scale
Model MA0500, Maxi Pillar
Model MA0510, Maxi Mast for Electric Chassis
Model MB0500, Maxilift Beige
Model MB0510, Maxilift with Battery Powered Chassis
Model MB0600, Maxilift with Scale - Beige
Model MB0610, Maxilift Battery Powered with Scale.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 1,017 units were distributed.
REASON Spring (roll) pin subject to shear in Maxilifts
greater than 5 years old.
PRODUCT Maximove Patient Lift, Non-AC powered,
used to move patients in a nursing home situation: Models KRA0300, MA0510,
KMA1004, KMB0810-06, KMB0830-06, KMB4500-12US, KMB6950-12US, KMB6970-12US,
KMB6980-12US.
CODE Maximove models KRA0300 (mast Model), KMB4500-12US,
KMB6950-12US, KMB6970-12US, KMB6980-12US, serial numbers GB 2097 784578
001 through GB 0899 819426 006; weeks 20/97 through 08/99
Model KMB4500-12US - Maximove with powered V chassis
Model KMB6950-12US - Maximove with powered parallel chassis
& scale
Model KMB6970-12US - Maximove with powered parallel chassis
Model KMB6980-12US - Maximove with powered V chassis
& scale
Maximove Combi models KRA0300 (Mast model) and KMA1004,
serial numbers start with GB or SE; weeks 03/96 through 05/99
Model KMA1004 - Maximove Combi Lift Arm Assembly
Maxilift Combi models MA0510 (Mast Model), KMB0810-06,
KMB0830-06, serial numbers GB 0596 770428 003 through GB 3496 773176 010;
weeks 05/96 through 34/96
Model KMB0810-06US, Maxilift Combi
Model KMB0830-06US, Maxilift Combi with Scale.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 1,465 units were distributed.
REASON Over depression of the locking spring pin results
in the lift arm not locking.
PRODUCT Marisa Patient Lift, Non-AC Powered, used
to move weak or highly dependent patients in a nursing home situation:
a) Model KGB2000-US, Marisa Complete with Jib, but no Scale; b) Model KGB2100-US,
Marisa Complete with Jib and with Scale ; c) Model KGA0200.
CODE All serial numbers below GB 3298 807390 002.
MANUFACTURER Arjo Ltd., Glouster, UK
RECALLED BY Arjo, Inc., Roselle, Illinois.
DISTRIBUTION Nationwide.
QUANTITY 1,331 lifts were distributed.
REASON Jib assembly plunger may not fully engage in the
carriage receptacle.
PRODUCT Vitros Cardiology Controls (human serum),
for in-vitro diagnostic use only, Catalog #865 0939.
CODE Lot number 50.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester,
New York.
DISTRIBUTION California, District of Columbia, Illinois,
Indiana, Montana, Nevada, Ohio, New York, South Carolina, Texas, Virginia,
Wisconsin, Australia, Brazil, Canada, Singapore, England and France.
QUANTITY 338 packs were distributed.
REASON Cardiology controls gave low values approximately
2 standard deviations below target values.
PRODUCT Cemented Hip Stem, Catalog #6098-0940.
CODE Case Code: 46364801
Serial Numbers: 20458S, 20459D, 20461S, 20462S, 20463S,
and 38086P.
MANUFACTURER Stryker Howmedica Osteonics, Allendale,
New Jersey.
DISTRIBUTION Illinois, Minnesota, Oklahoma and Canada.
QUANTITY 5 units were distributed.
REASON Mislabeling - The device is labeled having a 127
degree neck angle when in fact the hip stem actually have a 132 degree
neck angle.
PRODUCT IMx hCG Calibrators, for in Vitro Diagnostic
use. The Imx hCG Calibrators are for the calibration of the Imx Anallyzer
when used for the quantitative/qualitative determination of human chorionic
gonadotropin (hCG) for the early detection of pregnancy.
CODE List #3A63-01, Lot #55552Q100 EXP 5/13/00.
MANUFACTURER Abbott Health Products, Inc., Barceloneta,
Puerto Rico.
DISTRIBUTION Nationwide, Australia, Canada, Germany,
Italy, Japan, and Mexico.
QUANTITY 234 kits were distributed.
REASON The IMx hCG Calibrator lot 55552Q100 rates have
decreased over time which may result in elevated control values.
PRODUCT Pentalumen Thermodilution Catheter, Heparin
Coated, Flow-Directed Thermodilution Pulmonary Artery Catheder, Rx device
for rapid and accurate measurement of hemodynamic pressure and determination
of cardiac output using a cardiac output computer.
CODE List #412320401, Lot #59-249-SN.
MANUFACTURER Abbott Laboratories, Salt Lake City,UT.
RECALLED BY Abbott Laboratories, Abbott Park, Illinois.
DISTRIBUTION Nationwide, Canada, Chile.
QUANTITY 960 catheters were distributed.
REASON One or more of the lumens in the catheter may
be occluded.
PRODUCT Genesis II and Profix Porous Femoral Components,
sterile product, packaged one per container for use by an orthopaedic surgeon:
Genesis II Femoral Components:
Description Part Number
Lot
Sz 3 LT
71420036 00111302
Sz 4 LT
71420038 91106643
Sz 5 LT
71420040 00111462
Sz 5 LT
71420040 00111463
Sz 5 LT
71420040 00304339
Sz 5 LT
71420040 00304340
Sz 6 LT
71420042 91103882
Sz 6 LT
71420042 91103883
Sz 6 LT
71420042 91107062
Sz 6 LT
71420042 91107063
Sz 6 LT
71420042 91107064
Sz 6 LT
71420042 00101454
Sz 6 LT
71420042 00101457
Sz 7 LT
71420044 00206821
Sz 7 LT
71420044 00206822
Sz 4 RT
71420054 91201372
Sz 4 RT
71420054 91201373
Sz 4 RT
71420054 91201371
Sz 4 RT
71420054 91204594
Sz 4 RT
71420054 00101463
Sz 4 RT
71420054 00101464
Sz 4 RT
71420054 00111306
Sz 4 RT
71420054 00111307
Sz 4 RT
71420054 00111308
Sz 5 RT
71420056 91107068
Sz 5 RT
71420056 91107069
Sz 5 RT
71420056 91107070
Sz 5 RT
71420056 91106158
Sz 5 RT
71420056 90016159
Sz 5 RT
71420056 91106160
Sz 5 RT
71420056 91107067
Sz 5 RT
71420056 00111304
Sz 5 RT
71420056 00111304A
Sz 5 RT
71420056 00404566
Sz 5 RT
71420056 00404567
Sz 5 RT
71420056 00404563
Sz 5 RT
71420056 00404564
Sz 5 RT
71420056 00404565
Sz 7 RT
71420060 91204591
Sz 7 RT
71420060 91204592
Sz 7 RT
71420060 00206823
Sz 7 RT
71420060 00206824
Sz 7 RT
71420060 00406018
Sz 7 RT
71420060 00406017
Sz 7 RT
71420060 00103496
Profix Femoral Components:
Description Part Number
Lot
Sz 3 RT
71502130 00105665
Sz 4 RT
71502140 91100703
Sz 4 RT
71502150 91100704
Sz 4 RT
71502140 91107043
Sz 4 RT
71502150 91107044
Sz 4 RT
71502140 91107045
Sz 4 RT
71502150 91203073
Sz 5 RT
71502150 91101207
Sz 5 RT
71502150 91106635
Sz 5 RT
71502150 91106636
Sz 5 RT
71502150 91106146
Sz 5 RT
71502150 91106147
Sz 5 RT
71502150 91106634
Sz 5 RT
71502150 91107801
Sz 5 RT
71502150 91107802
Sz 5 RT
71502150 91107724
Sz 5 RT
71502150 91107725
Sz 5 RT
71502150 91107803
Sz 5 RT
71502150 91200417
Sz 5 RT
71502150 91200418
Sz 5 RT
71502150 91100419
Sz 5 RT
71502150 91200420
Sz 5 RT
71502150 92100416
Sz 6 RT
71502160 91101209
Sz 6 RT
71502160 91107805
Sz 6 RT
71502160 91107806
Sz 6 RT
71502160 91100706
Sz 6 RT
71502160 00209183
Sz 6 RT
71502160 00209184
Sz 6 RT
71502160 00301458
Sz 6 RT
71502160 00301457
Sz 6 RT
71502160 00301456
Sz 6 RT
71502160 00305645
Sz 2 LT
71502220 00405819
Sz 2 LT
71502220 91203766
Sz 2 LT
71502220 91204891
Sz 3 LT
71502230 91106628
Sz 3 LT
71500230 91106629
Sz 3 LT
71502230 91106630
Sz 3 LT
71500230 91106149
Sz 3 LT
71502230 91106150
Sz 3 LT
71500230 00109524
Sz 4 LT
71590001 91203525
Sz 4 LT
71590001 91203526
Sz 4 LT
71502240 91101931
Sz 4 LT
71502240 91101932
Sz 4 LT
71502240 91101933
Sz 4 LT
71502240 00104672
Sz 4 LT
71502240 00109525
Sz 4 LT
71502240 00301453
Sz 4 LT
71502240 00301454
Sz 4 LT
71502240 00310670
Sz 5 LT
71502250 91102580
Sz 5 LT
71502250 91102582
Sz 5 LT
71502250 91109920
Sz 5 LT
71502250 91109921
Sz 5 LT
71502250 91110383
Sz 5 LT
71502250 91204253
Sz 5 LT
71502250 91204254
Sz 5 LT
71502250 00109527
Sz 5 LT
71502250 00109528
Sz 5 LT
71502250 00111459
Sz 5 LT
71502250 00111461
Sz 5 LT
71502250 00200116
Sz 5 LT
71502250 00200337
Sz 5 LT
71502250 00200338
Sz 5 LT
71502250 00200339
Sz 6 LT
71502260 91107049
Sz 6 LT
71502260 91107050
Sz 6 LT
71502260 91107051
Sz 6 LT
71502260 00104674
Sz 6 LT
71502260 91108859
Sz 7 LT
71502270 91106148
Sz 7 LT
71502270 91200414
Sz 7 LT
71502270 00111298.
MANUFACTURER Smith and Nephew, Inc., Orthopaedic Division,
Memphis, Tennessee.
DISTRIBUTION Nationwide and international.
QUANTITY 945 units were distributed.
REASON The bead sintering process temperature was insufficient
for proper bead/substrate adhesion.
PRODUCT FreshLook Toric Soft Hydrophilic Contact
Lenses for Astigmatism.
CODE Lot numbers: 101297 EXP 2003-01, 101296, EXP 2003-01.
MANUFACTURER Wesley Jessen Corporation, Des Plaines,
Illinois.
DISTRIBUTION Nationwide.
QUANTITY 564 single blister trials and 246 6-packs were
distributed.
REASON Mislabeled for corrective power, cylinder and
axis.
PRODUCT Cordis Smart Nitinol Stent Transhepatic
Biliary System.
CODE
Catalog number 1440BB, Lot number X0200019;
Catalog number 1420BB, Lot number 40200246.
MANUFACTURER Cordis Corporation, Miami Lakes, Florida.
DISTRIBUTION Tennessee, West Virginia, California, Louisiana,
and Florida.
QUANTITY 12 units were distributed.
REASON Mislabeled guidewire size and mislabeled indication
for use.
PRODUCT Cardiology Controls (human serum), for
in vitro diagnostic use only.
CODE Lot #53 EXP 12/99.
MANUFACTURER Ortho-Clinical Diagnostics, Inc., Rochester,
New York.
DISTRIBUTION Alaska, California, Delaware, Indiana, Kansas,
Kentucky, New York, Ohio, Oklahoma, Pennsylvania, Wisconsin, Canada, Belgium,
and Germany.
QUANTITY 33 packs were distributed.
REASON Cardiology Controls gave low values approximately
2 standard deviations below target.
PRODUCT Lactate Membrane Kit Stat Profile M Series,
for use with the Stat Profile M Analyzer. The Stat M. Analyzer is intended
for in vitro diagnostic use by health care professionals and for Point-of-Care
usage in the quantitative determination of sodium, potassium, ionized calcium,
ionized magnesium, glucose, lactate, and BUN in serum, plasma, and whole
blood to evaluate the acid-base status of patients suspected of having
lactic acidosis.
CODE Lot numbers: 901129 and 801129.
MANUFACTURER Nova Biomedical Corporation, Waltham, Massachusetts.
DISTRIBUTION Arizona, Massachusetts, Florida, Wisconsin
and Germany.
QUANTITY 41 kits (6 membranes/kit) were distributed.
REASON Extended expiration date.