APRIL
2001
WEEK ENDING APRIL 6
PRODUCT: Roche Chemstrip 9 Urine Test Strips, Catalog No. 417109.
CODE: Lot No. 263053.
MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.
DISTRIBUTION: Nationwide.
QUANTITY: 13,178 vials.
REASON: One of the component pads for the leukocyte test
area was missing, which will result in a false negative result for leukocytes.
PRODUCT: DePuy PS Reusable Tourniquet Cuffs, Bier’s Block:
a)
PS Reusable Tourniquet Cuff, 18 inch, Single Hose, Bier’s Block, Catalog No.
6671-50-000.
b)
PS Reusable Tourniquet Cuff, 26 inch, Single Hose, Bier’s Block, Catalog No.
6671-52-000.
c)
PS Reusable Tourniquet Cuff, 26 inch, Single Hose, Bier’s Block, Catalog No.
6671-52-000.
d)
PS Reusable Tourniquet Cuff, 18 inch, Double Hose, Bier’s Block, Catalog No.
6672-50-000.
CODE: a) Lot No. U2EAG3000; b) Lot No. U1JAE3000; c) Lot
No. U2PAB3000; d) Lot No. U2EAG3000.
MANUFACTURER: DePuy Orthopaedics, Inc., Warsaw, IN.
DISTRIBUTION: Arkansas, Tennessee, Indiana, Alaska, New
York, Iowa, Florida, Texas, Washington, North Carolina. One account in Spain.
QUANTITY: 16
REASON: Deflation of the tourniquet cuff as a result of
the hose disconnecting from the port of the cuff.
PRODUCT: Dash Patient Monitors, Models 2000 and 3000 a) Dash Patient Monitor,
Model No. 2000; b) Dash Patient Monitor, Model No. 3000
CODE: All units.
MANUFACTURER: GE Medical Systems Information
Technologies, Inc., Milwaukee, WI.
DISTRIBUTION: Nationwide, worldwide.
QUANTITY: 8,702 devices.
REASON: The monitor alarms fail to sound after 414 days of
usage.
PRODUCT: Flowrider Micro Catheter: a) Model No. 105-5060(1.8F); b) Model No.
105-5062 (FlowRider II); c) Model No. 105-5063(1.5F)
CODE: Serial Numbers affected by the recall are: Model 105-5060
M980170
M980181 M980266 M980351 M980362A M980362B M980395 480134J 480334J 480334JA
490624J 500194J 500304J 500804J
510414J
510424J 510824J 510654J 520214J 520354J 480124J
Model
105-5062 FlowRider II 520594J 520894J 530014J 530444J 530974J 530984J 540254J
550904J 560374J 560374J-A 570254J
Model
105-5063 1.5F 511224J 520294J 530454J 540134J 540224J 540764J 540774J 550554J
550734J 550854J
MANUFACTURER: Micro Therapeutics, Inc., Irvine, CA.
DISTRIBUTION: States of CA & TX. Internationally to
Australia, Denmark, Turkey, France, Italy, Switzerland, India, Japan, Korea,
England, Germany, Spain, Brazil.
QUANTITY: 1,111 units.
REASON: The device fails to perform as designed. The device may leak therapeutic agents and
contrast media into the peripheral and neuro vasculature due to failure of the
catheter wall.
PRODUCT: Accu-Chek® Advantage® meters and Accu-Chek® Voicemate®.
a)
Accu-Chek Advantage I meter;
b)
Accu-Chek Advantage II meter;
c)
Voicemate System
CODE: a) Model Nos. 768, 870, 800683, 800684; b) Model
No. 213890; c) Model Nos. 2030802 and 3040208.
MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.
DISTRIBUTION: Nationwide, worldwide.
QUANTITY: 2 million.
REASON: A software problem causes the memory to store
erroneous values under specific circumstances.
If the user performs a test when the meter’s internal clock registers
12:00 (midnight) - 12:10 am on the day the meter believes is Day 1 of a 7 day
cycle, the test result can be incorrect. The same software problem also causes
the Voicemate meters for the visually impaired to orally report erroneous
values taken from the meter memory.
PRODUCT: Abbott Provider 5500 Infusion Pump; Abbott Provider 6000 Infusion
Pump
CODE: All.
MANUFACTURER: Abbott Laboratories, Inc., San Diego, CA.
DISTRIBUTION: Nationwide and Australia, Belgium,Canada,
England, France, Hong Kong, Indonesia,Ireland, Korea,Netherlands, Switzerland,
Taiwan
QUANTITY: 3,087.
REASON: The product can overinfuse in the "bolus
only" mode which does not result in a failure alarm.
PRODUCT: a) Customized Heart Lung Perfusion Packs, 44 catalog numbers:
#020151120, #020163509, #020295603,
#020298017, #020331604, #020385603, #020394603, #020410603, #020457603,
#020469510, #020878601, #020907216, #024497019, #067100001, #067105001,
#067115001, #067133001, #067138002, #078132012, #078149015, #078212007,
#078238005, #078274007, #078303008, #078322005, #078351007, #078385005,
#078429007, #078517002, #078595005, #078595006, #078634005, #078637004,
#078656003, #078713002, #078722002, #078728002, #078729004, #078733001,
#078739005, #078740002. #078766003, #078838003, #078876003
b)
Sterile Sample Customized Heart Lung Perfusion Packs #020824601, #020848601,
#020851601, #020883602, #067153001, #078424010
c)
Bulk Sterile Purge Line #029177100
CODE: Customized Heart Lung Perfusion Packs, 44 catalog
numbers:
a)
Lot #10F0323.
Lot #06F0323, 08F0386, 10F0051, 11F0163
Lot #06F0347
Lot #07F0038, 10F0453
Lot #09F0212, 09F0251, 10F0328
Lot #10F0254
Lot #10F0341
Lot #10F0260
Lot #10F0116
Lot #10F0410
Lot #10F0392
Lot #06F0193, 08F0231, 10F0353
Lot #06F0189, 08F0036, 08F0375, 10F0428
Lot #10F0110
Lot #11F0104 (added on 1/10/01)
Lot #10F0080
Lot #10F0194
Lot #10F0389
Lot #09F0266, 10F0362
Lot #11F0099
Lot #10F0024, 11F0024
Lot #11F0030
Lot #06F0089, 07F0185, 08F0258, 10F0013,
10F0369
Lot #07F0017, 08F0288, 09F0119
Lot #08F0256, 10F0290
Lot #07F0094, 08F0192, 09F0261, 10F0294
Lot #10F0102
Lot #06F0300, 07F0081, 08F0265, 10F0101
Lot #06F0168, 07F0100, 08F0194, 10F0011,
10F0384
Lot #06F0248, 08F0006, 09F0117
Lot #11F0098 (added on 1/10/01)
Lot #09F0269, 10F0286, 11F0115
Lot #06F0005, 06F0379, 09F0195, 10F0460
Lot #07F0003, 09F0265, 10F0461
Lot #06F0255, 08F0346, 10F0464
Lot #06F0159, 08F0011, 08F0348, 10F0368
Lot #06F0151, 09F0118
Lot #08F0180, 10F0276
Lot #05F0004, 08F0082
Lot #11F0111
Lot #04F0186, 06F0165, 11F0214
Lot #08F0253, 10F0191
Lot #09F0002, 11F0003
Lot #11F0210
b)
Lot #06F0862MP
Lot #08F0827MP
Lot #08F0832MP
Lot #09F0850MP
Lot #09F0832MP
Lot #09F0852MP
c)
Lot #06F0600
MANUFACTURER: COBE Cardiovascular, INC., Arvada, CO.
DISTRIBUTION: Nationwide.
QUANTITY: 3673.
REASON: Plastic one-way valve located in the arterial
filter purge line may break.
PRODUCT: Total Ossicular Reconstruction Prostheses - Wiet Flex H/A Offset Head
H/A, and Causse Flex H/A Notched H/A Offset:
a)
Weit Flex H/A Offset Head H/A, Catalog No. 0515.
b)
Causse Flex H/A Notched H/A Offset, Catalog No. 0518.
CODE: a) Lot No. 20365700; b) Lot No. 20355500.
MANUFACTURER: Medtronic Xomed, Inc., Jacksonville, FL.
DISTRIBUTION: PA, VA, NY, IL and OH.
QUANTITY: 44
REASON: The product labeling was switched.
PRODUCT: ALCYON Clinical Chemistry Analyzer. ALCYON Direct HDL.
CODE: Model Nos. 300 and 300i.
MANUFACTURER: Abbott Laboratories, Inc., Irving, TX.
DISTRIBUTION: Nationwide and International.
QUANTITY: 1,039 units.
REASON: There is possible to obtain depressed or lower HDL
Cholesterol results in some lipemic specimens when using the ALCYON Direct HDL
method.
PRODUCT:
i-STAT
Creatinine Cartridge
i-STAT
Catalog No. 320100Abbott laboratory List Nos. 06F10-01, 06F10-02.
CODE: Lot Nos. P00278, P00290, P00293, P00326, T00313,
T00313A, K00311, K00315, K00315A, K00316, K00316A, K00320, K00320A, and
K00322B.
MANUFACTURER: i-Stat Corp. East Windsor, NJ.
DISTRIBUTION: Nationwide, worldwide.
QUANTITY: 45,750.
REASON: A change in the manufacturing process causes these
cartridges to be incompatible with the analyzers (i-STAT Portable Clinical
analyzer and the Hewlett Packard Blood Analysis Module).
PRODUCT: Hemoclip S15 Ligating Clip Appliers, Catalog No. 523701.
CODE: Lot No. 587161.
MANUFACTURER: Weck Closure Systems, Research Triangle
Park, NC.
DISTRIBUTION: NY, RI, TX, and UT. One distributor in
France.
QUANTITY: 89.
REASON: A pinhole in the sterile blister pack.
PRODUCT: Nitinol Laser Grasper Set, Catalog No. NLGS-030115-UDH.
CODE: All Lot Numbers.
MANUFACTURER: Cook Urological, Inc., Spencer, IN.
DISTRIBUTION: Nationwide, and Canada, Hong Kong, Ireland,
Israel, Japan, Singapore, South Africa and Taiwan.
QUANTITY: 225.
REASON: The cannula may separate from the PINT shaft at
the proximal end inside the handle causing the handle to malfunction.
PRODUCT: Sample Cups for use on Roche/Hitachi and Elecsys analyzers, Catalog
40904100.
CODE: Lot No. 714747.
MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.
DISTRIBUTION: Nationwide, VA hospitals in IA, MN, WA, and
OH.
QUANTITY: 500,000 cups.
REASON: Some sample cups in this lot are manufactured
incorrectly in that the liquid reservoir space is decreased. The decrease space
could result in probe crash, compromised dead volumes and the possibility of samples
being read incorrectly without a warning being sent to the system.
PRODUCT: Ancure® Endograft® System
CODE: Ancure Tube System Device Part Number: 13464.
MANUFACTURER: Guidant Corporation/Endovascular Solutions
, Menlo Park, CA.
DISTRIBUTION: CA.
QUANTITY: 1 unit.
REASON: Device component did not get ultrasonically
washed.
PRODUCT: Femoral Hip Stems
CODES: A) Lat. Answer Cemented Femoral 9 x 125 mm
Lateralized Stem. Part 162501, lots 314750, 385750, 462760 and 538800.
B) Lat.
Answer Cemented Femoral 11.0 x 135 mm Lateralized Stem. Part 162502, lots
013820, 087010, 138970, 138980, 156390, 207720,
241120,
252630, 264810, 302780, 347780, 462770, 538810, 587870, 623710 and 666370.
C)
CB Answer Cemented Femoral 9.0 x 125 mm Stem. Part CP155895, lots 314520,
314530, 403400 and 462380.
D)
Mallory/Head Cemented Femoral Interlok /minus 5 mm neck, 5 mm x 7 mm. Part
105606, lots 029110, 155570, 338210 and 474040.
E)
Mallory/Head Cemented Femoral Interlok/with Collar 7.0 x 140 mm Stem. Part
105607, lots 113800, 113810, 137940, 137950, 155580, 170500,
183130,
183140, 194670, 207420, 229400, 264510, 013510, 099850, 289400, 289410, 302350,
435370, 487870, 487880, 500930, 511980, 511990, 523800, 523810, 538270, 549180,
and 549190.
F)
Mallory/Head Collared Femoral 7.0 x 140 mm Stem. Part RD116807, lot
207230.
G)
Mallory/Head C Femoral Reduced 5P/7D x 105 mm minus 5 mm neck. Part 154682, lot 264440.
H)
Modified Mallory/Head C Femoral 5 mm x 7 mm x 115 mm stem minus 5 mm neck. Part
CP154683, lot 326020.
MANUFACTURER: Biomet Orthopedics, Inc., Warsaw, IN.
DISTRIBUTION: United States, Canada, France and Korea.
QUANTITY: 159.
REASON: The cobalt-chrome alloy may have a streak of pure
cobalt.
PRODUCT: Boston Scientific/Microvasive Flexima Soft (Flexible) Tip Ureteral
Catheter:
Catalog
Number Description
400-215 4 French x 70 cm
400-216 5 French x 70 cm
400-217 6 French x 70 cm
400-218 7 French x 70 cm
400-219 8 French x 70 cm
CODE: All Lots.
MANUFACTURER: Boston Scientific Corp., Spencer, IN.
RECALLED BY: Boston Scientific Corp., Natick, MA
DISTRIBUTION: Nationwide , VA Medical Centers in NC, FL,
AR, and Madigan Army Medical, WA. Foreign: Singapore, Canada, France.
QUANTITY: 859 boxes (all sizes) = Boxes of 20.
REASON: Radiopaque flexible tip may detach from the
Ureteral Catheter.
PRODUCT: BVS 42 French Arterial Cannula provided in the BVS Pump Set or as an
individual cannula.
CODES: Recall Lots Numbers:
00DPM3670 00DPM3770
00EPM0800 00EPM0810
00EPM1200 00EPM1360
00EPM1370 00EPM2100
00EPM2230 00EPM3430
00EPM3780 00EPM4550
00FPM2830 00FPM3010
00GPM2940 00GPM3260
00GPM3270 00HPM0070
00HPM3130
MANUFACTURER: Medtronic Cardiac Surgical Products, Rancho
Dominguez, CA.
RECALLED BY: Abiomed, Inc., Danvers, MA
DISTRIBUTION: Nationwide, Canada, Spain, Japan,
Australia, Sweden, Netherlands.
QUANTITY: 220.
REASON: Cannula may delaminate at the proximal connector
end and not connect to Blood Pump.
PRODUCT: Pleur-Evac, Model A-6002
CODES: Lot Number:
412335.
MANUFACTURER: Genzyme Surgical Products Corp., Fall
River, MA.
DISTRIBUTION: CA, MS, FL, MA, MD, NC and Canada.
QUANTITY: 444Units.
REASON: Breach in chamber wall may compromise water seal
of chest drain.
PRODUCT:
MultiDiagnost
3 Image Intensified Fluroscopic X-Ray System.
MultiDiagnost
4 Image Intensified Fluroscopic X-Ray System.
CODE: All systems installed prior to March 2000.
MANUFACTURER: Philips Medical Systems, Best, Netherland.
RECALLED BY: Philips Medical Systems North America,
Inc., Shelton, CT
DISTRIBUTION: Nationwide.
QUANTITY: 53.
REASON: Ankle clamp may detach from footplate and cause
X-Ray table to tilt and tip.
PRODUCT: B-K Medical Laproscopic transducers, TYPES: 8566, 8566-S and
8666.
CODES: B-K Laproscopic transducers as follows: TYPE:
S/N:8566 18167668566-S
1816755,1816756,1816758,1816759,1817050-1817059
1817061,1817064,1817066-
1817072,
1817074-1817076, 1821843 1817052,1817053, 8666 1817608-1817613,
1817616,
1817619-18177621
MANUFACTURER: B-K Medical A/S, Gentofte, Denmark.
RECALLED BY: B-K Medical Systems, Inc., Wilmington, MA
DISTRIBUTION: Nationwide.
QUANTITY: 25.
REASON: Defect at tip of laproscopic probe may effect
disinfection and safety.
PRODUCT: Apligraf (Graftskin).
CODE: Manufacturing Lot: GS0008.15.03
Unit
Numbers: 1,3,4,5,10,11,13,14,15,17,19,20,22,24,25,28,31,32, 33,35, 36,38,39,40,
41, 42,43,44,45,46,47,49,50,51,54,55,56,57,58,60,62,63, 64,65,71,and 114.
MANUFACTURER: Organogenesis, Inc., Canton, MA.
DISTRIBUTION: Nationwide.
QUANTITY: 46.
REASON: Product Contamination-Staphyloccoccus cohnii.
PRODUCT: Ritter and Midmark brand Medical Examination Lights, ceiling mounted,
AC-Powered, Models: 354 and 355.
CODE: All Serial Numbers built between 1/4/2000 and
6/20/2000.
MANUFACTURER: MIidmark Corp., Versailles, OH.
DISTRIBUTION: Nationwide and Australia, Philippines,
Netherlands, and France.
QUANTITY: 446 units.
REASON: The light arm assembly may fall from the ceiling,
due to a manufacturing defect.
WEEK ENDING APRIL 20
PRODUCT: Dr. Sweat’s Atlas Orthogonal Chiropractic Adjustment Table (aka Atlas
Table).
CODE: Model No. WW0O11OO, Serial Nos. 100108 through
100175.
MANUFACTURER: Wuestec Medical, Inc., Mobile, AL.
DISTRIBUTION: United States, Canada and Japan.
QUANTITY: 68
REASON: A patient could be pinned to the stylus by the
headrest.
PRODUCT: Alcon Custom Paks containing Becton-Dickinson 3 ml syringe with 21G x
1.5” Needle.
CODES: 183095H 183114H 183141H 183172H 183223H 183243H
183426H 183464H 183666H 183685H 184047H 184522H 184529H 184560H 184601H 184611H
184629H 184666H 184667H 184707H 184782H 184812H 184838H 184850H 184932H 185055H
185099H 185121H 185181H 185436H 185614H 185648H 185672H 185745H 185771H 185791H
185793H 186061H 186088H 186120H 186207H 186569H 186791H 186910H 186988H 176970H
177292H 177763H 177770H 178538H 178623H 178679H 178694H 178779H 178796H 178815H
178931H 178974H 179158H 179170H 179214H 179247H 179476H 179598H 179712H 179756H
179786H 180032H 180049H 180131H 180149H 180178H 180191H 180208H 180266H 180357H
180367H 180524H 180905H 181222H 181254H 181282H 181284H 181377H 181403H 181405H
181958H 181974H 182023H 182606H 182735H 182773H 182983H 182985H 183017H 183057H
MANUFACTURER: Alcon Laboratories, Houston, Texas.
DISTRIBUTION: Nationwide.
QUANTITY: 808.
REASON: The 3 ml syringe(s) with 21 gauge needle contained
in the Custom pak may have a loose or missing protector cap.
PRODUCT: Cryovalve Allograft; Model No. AV00
CODES: Serial No. 6865724.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: Phoenix, AZ.
QUANTITY: One.
REASON: The firm received additional donor information
from the procurement agency, confirming that a duplicate set of serologies
possessed discordant HbsAg results. The tissue was released in error.
PRODUCT: Cryovalve Allograft; a) Model No. AV05;b)Model No. PV05
CODES: a) Serial No. 3981339; b) Serial No.
3981347.
MANUFACTURER: Cryolife, Inc., Kennesaw, GA.
DISTRIBUTION: San Francisco, CA., and Columbus, OH.
QUANTITY: Two.
REASON: The firm’s donor did not meet current guidelines
regarding serodilution of plasma because of the amount of transfused/infused fluids administered.
PRODUCT: Ohmeda Medical Giraffe™ Omnibed™, Various Serial Numbers.
CODE: Serial Number HDGD00104 HDGD00107 HDGD00111
HDGD00113 HDGD00114 HDGD00115 HDGD00118 HDGD00120 HDGD50202 HDGD50204 HDGD50205
HDGD50206 HDGD50207 HDGD50208 HDGD50209 HDGD50210 HDGD50211 HDGD50212 HDGD50215
HDGD50216
HDGD50218
HDGD50219 HDGD50220 HDGD50222 HDGD50223 HDGD50226 HDGD50227 HDGD50228 HDGD50242
HDGD50243 HDGD50244 HDGD50245 HDGD50260 HDGD50261 HDGD50262 HDGD50263 HDGD50264
HDGD50265 HDGD50266 HDGD50267 HDGD50268 HDGD50269 HDGD50270 HDGD50271 HDGD50272
HDGD50274 HDGD50275 HDGD50276 HDGD50277 HDGD50278 HDGD50280 HDGD50281 HDGD50282
HDGD50283 HDGD50284 HDGD50287 HDGD50288 HDGD50289 HDGD50296 HDGD50297 HDGD50298
HDGD50299 HDGD50300 HDGD50301 HDGD50302 HDGD50303 HDGD50304 HDGD50305 HDGD50306
HDGD50307 HDGD50308 HDGD50309 HDGD50310 HDGD50311 HDGD50313 HDGD50314 HDGD50314
HDGD50315 HDGD50316 HDGD50317 HDGD50318 HDGD50324 HDGD50325 HDGD50327 HDGD50328
HDGD50329 HDGD50330 HDGD50331 HDGD50332 HDGD50333 HDGD50334 HDGD50335 HDGD50336
HDGD50337 HDGD50338 HDGD50339 HDGD50340
HDGD50341
HDGD50342 HDGD50343 HDGD50345 HDGD50346 HDGD50347 HDGD50348 HDGD50349 HDGD50350
HDGD50353 HDGD50354 HDGD50355 HDGD50359 HDGD50360 HDGD50361 HDGD50362 HDGD50363
HDGD50364 HDGD50366 HDGD50368 HDGD50369 HDGD50370 HDGE50001 HDGE50002 HDGE50003
HDGE50004 HDGE50005 HDGE50006 HDGE50007 HDGE50009
International
Serial Numbers HDGD50236 HDGD50234 HDGD50235 HDGD00001 HDGD00002 HDGD50229
HDGD50231 HDGD50232 HDGD50233 HDGD50388 HDGD50389 HDGD50001 HDGD50237 HDGD50239
HDGD50291 HDGD50292 HDGD50377 HDGD50379 HDGD50256 HDGD50257 HDGD50258 HDGD50259
HDGD50254 HDGD50255 HDGE50028 HDGD00110 HDGD50224 HDGD50319 HDGD50371 HDGD50249
HDGD50246 HDGD50248 HDGD50238 HDGD50320 HDGD50321 HDGD50293 HDGD50250 HDGD50240
HDGD50290 HDGD50294 HDGD50376 HDGD50378 HDGD50380 HDGD50381 HDGD50384 HDGD50386
HDGD50385 HDGD50247 HDGD50251 HDGD50252 HDGD50230
MANUFACTURER: Ohmeda Medical, Laurel, MD.
DISTRIBUTION: Nationwide, Austria, Poland, Ireland,
Sweden, Norway, Belgium, Estonia, Finland, Canada, Italy, Spain, Germany,
Netherlands, Japan, United Kingdom.
QUANTITY: 178.
REASON: Oxygen concentration variations (resulting in too
much or too little oxygen) may occur inside the infant incubator compartment
when the device is operated in the "incubator" mode.
PRODUCT: Coated VICRYL (polyglactin 910) suture, MONOCRYL (poliglecaprone 25)
suture, PDS II (Polydioxanone) suture, E-Pack Procedure Kits.
CODES:
Item
# Lot #
J00JG QA2665
J195H QA2504
J259H PP7868
J259H PP7869
J259H QA7573
J259H QA7574
J259H QA7575
J260H QA7176
J260H QA7189
J260H QA7395
J260H QA8009
J260H QB7107
J260W31 QA7394
J261H QA7142
J261H QA7426
J261H QA7445
J261H QA7540
J266H PP7882
J266H QA7156
J266H QA7242
J266H QA7953
J304H PP7398S
J304W22 QA7110
J304W22 QA7438
J304W22 QA7580
J305H QA7584
J316H PP7883
J316H QA7209
J316H QB7153
J316H QB7161
J316W31 QA7422
J316W31 QA7925
J317H QA7162
J317H QA7163
J317H QB7554
J317W31 QA7637
J317W31 QB7108
J329W21 PP7824
J339H PP7873
J339H QA7397
J339H QA7460
J339H QA7524
J339H QA7613
J339W31 PP7872
J339W31 QA7143
J340H PP7861
J340H QA7130
J340H QA7393
J340H QA7937
J340H QA7957
J340W31 QA7571
J346H QA7153
J346H QA7180
J346H QA7339
J346H QA7423
J346H QA7489
J346H QA7595
J346H QA8006
J346W31 QA7146
J363H QA2400
J364H
QA2450
J365H PP2684
J365H QA2658
J369H QA2508
J370H QA2519
J370H QA2579
J371H QA2460
J371H QA2659
J375W21 QA7644
J416H PP7884
J416H QA7127
J416H QA7141
J416H QA7262
J416H QA7263
J416H QA7264
J416H QA7269
J416H QA7290
J416H QA7303
J416H QA7940
J416W31 PP7836
J417H QA7638
J417H QA7653
J417H QA7660
J417H QA7661
J417H QA7681
J417H QA7990
J417H QA8021
J446V21 PP7828
J459H QA7417
J459H QA7542
J490G PP7834
J493G QA7369
J493V31 QA7576
J494G QA7382
J494G QA7982
J494H QA7995
J496G QA7155
J496G QA7280
J496G QA7463
J496G QA7560
J496G QA7673
J496H PP7885
J496H PP7886
J496H QA7177
J496H QA7178
J496H QA7203
J496H QA7254
J496H QA7281
J496H QA7430
J496H QA7561
J496H QA7562
J496H QA7594
J496H QA7675
J496H QB7130
J496H QB7538
J507G QA7432
J507G QA7519
J533H PP7449S
J533H QA7497
J568H PP2677
J568H QA2580
J569H QA2466
J569H QA2553
J588H QA7418
J589H QA7543
J589W21 QA7419
J597G QA7234
J603H QB7542
J603H QB7543
J607H PP2735
J607H QA2540
J607H QA2596
J614H PM2727S
J614H QA2418
J615H QA2606
J616H PP2704
J616W21 PP2752
J616W21 QA2431
J618W21 QA2577
J617H QA2572
J643H PM2502S
J644H QA2479
J645H QA2595
J646H QA2617
J683H PP7819
J699H QA7915
J808Q21 QA2573
J845G QA7224
J845G QA7949
J904T QA2526
J904T QA2527
J904T QA2533
J904T QA2538
J904T QA2594
J905T QA2571
J905T QA2581
J906G QA2692
J907V21 QA2569
J910T PP2753
J910T QA2463
J910T QA2471
J910T QA2549
J911T PP2693
J911T QA2512
J911T QA2593
J912G PM2716S
J912G QA2435
J912G QA2436
J913G QA2570
J931H PP2585
J945H PP7653S
J945H QA7119
J945H QA7147
J945H QA7165
J945H QA7341
J945H QA7607
J945H QA7919
J945H QA7958
J945H QA8007
J946H QA7246
J946H QA7342
J946H QA7938
J946H QB7534
J977H QA2555
J978H PL2689S
J979H PP2731
J979H QA2509
J980H PP2552
JB47W21 PP2577
JB94730 QA2442
Y399H PP2681
Y426H QA7504
Y426H QA7930
Y427H QA7170
Y493G QA7365
Y493G QA7366
Y496G QA7501
Y909G QA7379
Y910G QA2212
Y911G QA7554
Z127H PP9092
Z127H QA7539
Z148H PP9089
Z317H QA7535
Z333H QA7217
Z333W20 QA7216
Z340W20
QA7472
Z347H QB9271
Z352H QA7496
Z357H QA7493
Z359T PP2587
Z370T QA2445
Z371T QA2582
Z398H QA7462
Z398H QA7522
Z421H QA7431
Z452H PM9788S
Z463G QA7579
Z466H QA7225
Z495V21 QA7133
Z496G QA7308
Z496G QA7309
Z496G QA7310
Z496G QA7331
Z569T QA2592
Z823G QA7271
Z844G QA7221
Z877G QA2575
Z877G QA2605
E-Code E-Batch #
4829E QAT391
5835E QAT395
6327E QAT409
6291E QAT447
5412E QAT456
6178E QAT500
4007E QBT003
3116E QBT009
6217E QBT020
4901E QBT028
5367E QBT045
5864E QBT053
5519E QBT056
6420E QBT057
5296E QBT061
3494E QBT063
5413E QBT070
5765E QBT072
6285E QBT074
5923E QBT087
6243E QBT099
5461E QBT103
4392E QBT104
5007E QBT105
5196E QBT118
5865E QBT122
5674E QBT130
6291E QBT132
6500E QBT136
E3638 QBT139
2048E QBT142
6403E QBT143
6045E QBT146
6135E QBT149
1511E QBT164
E7260 QBT206
MANUFACTURER: Ethicon, Inc., San Angelo,
TX.
DISTRIBUTION: United States and
Internationally.
QUANTITY: 1,248,876.
REASON: Possibly non-sterile
sutures.
PRODUCT: OctoBase Retractor Rack (product number 28701).
CODE: All distributed units of
the product were recalled.
MANUFACTURER: Max Hauser GmbH, D-78507
Tuttlinger, Germany.
RECALLED BY: Medtronic Cardiac Surgery Technologies,
Minneapolis, MN
DISTRIBUTION: California, Georgia,
Illinois, Iowa, Maryland, Pennsylvania and Wisconsin, and Washington, DC.
QUANTITY: 18 units.
REASON: The retractor may lock-up
during use.
PRODUCT: Medtronic DBS Lead Kits, Models 3387 and 3389, For
deep brain stimulation.
CODES: All lots distributed
prior to January 5, 2001.
MANUFACTURER: Medtronic, Inc.,
Neurological Division, Minneapolis, MN.
DISTRIBUTION: Nationwide and Australia,
Canada, China, Japan and The Netherlands.
QUANTITY: 11043 leads.
REASON: Some electrodes in the
leads are not connected to the proper connector sleeve.
PRODUCT: Boston Scientific Scimed Maverick Monorail PTCA
Dilatation Catheters, Models H7493027515150, H7493027509200, H7493027515250,
H7493027515300, H7493027530400, H7493027520150, H7493027530200, H7493027520250,
H7493027520300, H7493027515400,
H7493027515270, H7493027515200, H7493027515350,
H7493027520200, H7493027520350, H7493027520400, H7493027520270, H7493027515220,
H7493027515320, H7493027520320, H7493027520370, H7493027515370 and
H7493027509220.
CODES: All remaining lots of the
products at consignees are being recalled.
MANUFACTURER: Boston Scientific Scimed,
Inc., Maple Grove, MN.
DISTRIBUTION: Nationwide and 11 European
Countries.
QUANTITY: 684 catheters.
REASON: Possibility of a hole
between the wire and the inflation lumens.
WEEK ENDING APRIL 27
PRODUCT: CeeOn foldable Intraocular Lens, Model 920
CODE: Serial nos. beginning with
081E.
MANUFACTURER: Pharmacia & Upjohn
Company, Kalamazoo, MI.
DISTRIBUTION: Nationwide.
QUANTITY: 80.
REASON: The lenses from a batch
with serial nos. beginning with 081E may have the diopter mislabeled. (Lenses
labeled as 18.0 diopter may actually be 23.5 diopter lenses and vice versa.)
PRODUCT:
Trans Lift Resident Sling Lift (Non-Ac powered
patient lift ).
Trans Lift Resident Sling Lift, Model No. P433A.
Trans Lift Resident Sling Lift, Model No. P433B.
CODE: Serial nos. LT100001 to
LT100080 and LT00451 to LT00817.
MANUFACTURER: Hill-Rom, Inc.,
Charleston, SC.
DISTRIBUTION: Nationwide and Israel.
QUANTITY: 447 units.
REASON: The devices can induce a
weld failure due to metal fatigue.