NOVEMBER 2002

 

WEEK ENDING NOVEMBER 2

 

PRODUCT Aesculap Ti Bone Screws, 4x56 mm.
CODE Lot number 5634922.
RECALLING FIRM/MANUFACTURER Recalling Firm: Aesculap, Inc., Center Valley, PA.
Manufacturer: Aesculap Ag & Co. Kg. Tuttlingen, Donau, Germany.
REASON Smaller than specified core diameter may lead to screw breakage during and post-implantation.
VOLUME OF PRODUCT IN COMMERCE 55 units.
DISTRIBUTION FL, NJ, and UT.

 

PRODUCT a) Meridian Medical Systems (MMS) brand Wye-Swivel, Plain; Part/Model Number 020104347;
b) Meridian Medical Systems (MMS) brand Wye-Swivel, GSP; Part/Model Number 020104348.
CODE a) Lots 347270402, 352940502, 355440502, 355630502, 357260502, 356960502, 35810602 and 357270502;
b) Lots 353390502, 356160502, 357290502 and 357280502.
RECALLING FIRM/MANUFACTURER Meridian Medical Systems, Inc., Indianapolis, IN.
REASON Swivel leg may crack and leak at connection with the body.
VOLUME OF PRODUCT IN COMMERCE 138,600 wyes.
DISTRIBUTION Costa Rica.

 

PRODUCT Fabius GS Anesthesia Gas Machine.
CODE Catalog number 4117110.
RECALLING FIRM/MANUFACTURER Drager Medical, Telford, PA.
REASON Intermittent leaks associated with APL valve.
VOLUME OF PRODUCT IN COMMERCE 764 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT 0.5cc 30G x 5/16 Walgreens brand syringes (cases of 5 boxes of 100 or boxes of 100 each)and .5cc 29GA x 1/2" (12.7mm) insulin syringe.
CODE Catalog No; Walgreens: 676987, BD's: 928854 

Lot Codes: 8742; 8743; 8779; 8780; 8781; 8782; 8783;8784; 8785; 8786; 8804; 8814; 8815; 8816.
Catalog No.: Walgreens: 677258, BD's 928851
Lot Codes: 8230; 8764; 8765; 8766; 8774; 8775; 8776; 8777; 8787; 8795; 8796; 8797; 8798; 8799; 8800; 8801; 8802; 8803; 8805; 8806; 8807;
8808; 8809; 8822.
RECALLING FIRM/MANUFACTURER Recalling Firm: Becton Dickinson & Co., Franklin Lakes, NJ.
Manufacturer: Boin Medica Co. Inc., Kumi City, Kyungbuk, Korea.
REASON Product has a recessed cannula which makes it difficult to remove the bubbles.
VOLUME OF PRODUCT IN COMMERCE 8,683,000 devices.
DISTRIBUTION Nationwide.

 

PRODUCT SynchroMed EL Implantable Infusion Pumps, Models 8626-10, 8626L-10, 8627-10, 8627L-10, 8626-18, 8626L-18, 8627-18, 8627L-18.
CODE All serial numbers.
RECALLING FIRM/MANUFACTURER Medtronic, Inc., Neurological Division, Minneapolis, MN
REASON Inadequate directions for use.
VOLUME OF PRODUCT IN COMMERCE 55,000 pumps (about 46,000 in the U.S. and 9,000 in foreign countries).
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT SABRE Bioabsorbable Polymer Sling With Introducer, catalog numbers 93-1030 (1.0 cm x 3.0 cm sling) and 93-1575 (1.5 cm x 7.5 cm sling) and SABRE Introducer, catalog number 93-1000.
CODE All lot numbers of catalog numbers 93-1000, 93-1030 and 93-1575, distributed prior to the recall, are affected.
RECALLING FIRM/MANUFACTURER Recalling Firm: Mentor Minnesota Inc., Minneapolis, MN.
Manufacturer: Prosurg Inc., San Jose, CA.
REASON Holes observed in the sterile packaging.
VOLUME OF PRODUCT IN COMMERCE 379 units.
DISTRIBUTION Nationwide.

 

PRODUCT Lorenz brand 99-7215-01 Low Profile Center Drive 1.5X15mm Titanium Screw. Sold one per package and 5 per package.

CODE Lot Numbers 206770, 163140, 132960, 113440, 113450, 098740.
RECALLING FIRM/MANUFACTURER Walter Lorenz Surgical, Inc., Jacksonville, FL.
REASON Screws were not fully cleaned per current SOP's before distribution.
VOLUME OF PRODUCT IN COMMERCE 193.
DISTRIBUTION Nationwide and Canada, Germany and Japan.

 

PRODUCT Perry Baromedical Hyperbaric Chambers- SIGMA MP Multiplace Hyperbaric Oxygen Treatment Chambers. These prescription devices are used in hospitals and clinics to treat multiple patients at a time for conditions such as air or gas embolism, gas gangrene, necrotizing soft tissue infections and thermal burns.
CODE All codes/serial numbers involved.
RECALLING FIRM/MANUFACTURER Perry Baromedical Corporation, Riviera Beach, FL
REASON Change testing of Fire Suppression System to monthly.
VOLUME OF PRODUCT IN COMMERCE 18.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT INTRALASE FS 600 C Laser System (Model 1), Laser Keratome.
CODE All codes.
RECALLING FIRM/MANUFACTURER IntraLase Corporation, Irvine, CA, by letter dated October 2, 2002.
REASON Design defect, wire breakage, causes laser failure, interrupting surgery.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION Nationwide and Mexico.

 

PRODUCT Palco Laboratories brand Pulse Oximeter; Models: 100, 130, and Aero (non-medical pulse oximeter) a) For Model 100 Product Number is: 1001010; b) For Model 130, Product Number is: 1001013; c) For AERO Model, Product Number is: 1001012.
CODE For Serial Numbers:
a) Serial Numbers are: 1270000001 to 1270000382 (may contain -01 at the end) 12700100001 to 12700100775;
b) Serial Numbers are: 1030000001 to 1030000055 (number may contain -01 at the end);
c) Serial Numbers are: 1260000001 to 1260000026 (number may contain -01 at the end) 12600100001 to 12600100045.
RECALLING FIRM/MANUFACTURER Palco Laboratories, Inc., Santa Cruz, CA.
REASON A capacitor was loaded backwards into the Pulse Oximeter.
VOLUME OF PRODUCT IN COMMERCE 1050 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Access 2 Immunoassay Systems -- Systems Software Versions 1.0; 1.1; 1.2; and 1.3.1.
CODE Product Name: Access 2 Software Part Number: 973074

Lot Number

Software Version

212702

1.3.1

212701

1.3.1

211403

1.3

210332

1.3

210331

1.3

108609

1.2

108104

1.2

107317

1.2

106682

1.2

106447

1.2

106146

1.1

105903

1.1

105270

1.1

104958

1.1

104485

1.1

103905

1.0

103436

1.0

103010

1.0.

RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA.
REASON Erroneous result flags can result on printed reports and screen displays in rare circumstances.
VOLUME OF PRODUCT IN COMMERCE 442.
DISTRIBUTION Nationwide.

 

PRODUCT Vortex Port-LP Access System with Attachable Catheter.
CODE REF P12155, LOT 981201, 2003-12 EXPIRATION DATE.
RECALLING FIRM/MANUFACTURER Recallinf Firm: Horizon Medical Products, Inc., Manchester, GA.
Manufacturer: Norfolk Medical Products, Inc., Skokie, IL.
REASON Mislabeling of Vortex Port-LP Access System with Attachable Catheter.
VOLUME OF PRODUCT IN COMMERCE 45 units.
DISTRIBUTION AL, FL, IN, MK, NY, PA and TX.

 

PRODUCT INTERLASE FS 600 C Laser System (Model 1), Laser Keratome.
CODE All units.
RECALLING FIRM/MANUFACTURER IntraLase Corp., Irvine, CA, by letters dated October 2, 2002.
REASON Cooling system problem causes machine to become inoperable.
VOLUME OF PRODUCT IN COMMERCE 30 units.
DISTRIBUTION Nationwide and Mexico.

 

PRODUCT "FrameLock" device, Product Number 960-808, intended for intra-operative use with the LandmarX Image Guided Surgery System as a device to regidly mount a reference arc to a patient's skull. The product has an open cannula nut which is missing for the referenced lot number. The kit is packaged in a metal sterilization tray which is wrapped in plastic.
CODE Lot 23353200.
RECALLING FIRM/MANUFACTURER Xomed, Inc., Jacksonville, FL, by letter dated September 4, 2002.
REASON Framelock assemblies packed with Open Cannula Nuts.
VOLUME OF PRODUCT IN COMMERCE 22.
DISTRIBUTION Nationwide and France, the Netherlands and Japan.

 

WEEK ENDING NOVEMBER 9

 

PRODUCT a) IntraStent DoubleStrut ParaMount, Premounted Biliary    Stent System;

b) Protégé Self Expanding Nitinol Stent, Biliary System.

c) IntraStent DoubleStrut ParaMount XS Premounted Biliary Stent System.

CODE a) Model Number SPM16-26-05-B, Lot Number MF2892;

Model Number SPM16-26-07-B, Lot Numbers MF2964, MF3952, MF2966;

Model Number SPM16-26-08-B, Lot Number MF2965;

Model Number SPM16-16-05-B, Lot Numbers MF2967, MF4236,        

MF2893, MF4191;

Model Number SPM16-36-08-B, Lot Number MF2973.

b) Model Number SE7-9-20-80, Lot Numbers MF2935, MF3803;

Model Number SE7-7-60-120, Lot Number MF2941;

Model Number SE7-9-20-120, Lot Numbers MF2942, MF3473, MF3747, MF4135;

Model Number SE7-6-40-120, Lot Numbers MF2940, MF3296;

Model Number SE7-7-40-80, Lot Numbers MF2950, MF3805.

c) Model Number SPM14-12-07-B, Lot Number MF3056.

RECALLING FIRM/MANUFACTURER Sulzer IntraTherapeutics Inc., St. Paul, MN

REASON Some of the pouches for maintaining device sterility were unsealed.

VOLUME OF PRODUCT IN COMMERCE 350 units.

DISTRIBUTION Nationwide and Brazil, France, Greece, Italy and Taiwan.

 

PRODUCT EBV-VCA IgG ELISA and EBV-VCA IgM ELISA, diagnostic test kits, packaged under the Meridian Bioscience label.

These kits are: a) Epstein-Barr Virus (EBV) IgM; b) IgG Viral-Capsid-Antigen (VCA) Test Systems.

CODE

Description    Catalog No.   Lot No.

EBV-VCA IgM     626096       01012519

EBV-VCA IgG     624096       02017062 and 02017063.

RECALLING FIRM/MANUFACTURER Recalling Firm:  Meridian Bioscience, Inc., Cincinnati, OH

Manufacturer:  Zeus Scientific, Inc., Branchburg, NJ.

REASON Inaccurate test results (false positive or false negative) due to label error.

VOLUME OF PRODUCT IN COMMERCE a) 655 kits (IgM);  b) 290 kits (IgG).

DISTRIBUTION Italy and Belgium.

 

PRODUCT Hand Innovations, Inc. brand of Distal Volar Radius Locking Plate System, Catalog  Number is DVR-ST, the common name for the device is the Distal Volar Radius Locking Plate with pegs and screws.

CODE All lot numbers of the device are involved.

RECALLING FIRM/MANUFACTURER Hand Innovations, Inc. Miami, FL

REASON Instructions for use contain an incorrect sterilization procedure.

VOLUME OF PRODUCT IN COMMERCE 211.

DISTRIBUTION Nationwide and Switzerland, Venezeula, Brazil, Argentina and Mexico.

 

PRODUCT Synchron LX 20, Part # 466101; Synchron LX 20 Pro, Part # 466200.

CODE All units with software version 2.1 are affected.

RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA

REASON Low results on the cartridge chemistry assays, syringe valve seat issue.

VOLUME OF PRODUCT IN COMMERCE 793.

DISTRIBUTION Nationwide and Canada.

 

PRODUCT a) Exactech brand Optetrak CR Tibial Insert (catalog no. 200-22-09);

b) Optetrak PS Tibial (catalog # 204-22-09) inserts. These are used as implants during a knee replacement surgery.

CODE a) Serial numbers 0388389 through 0388412; b) Serial numbers 0388600 through 0388623.

RECALLING FIRM/MANUFACTURER Exactech, Inc., Gainesville, FL.

REASON The PS tibial insert was labeled as a CR tibial insert.

VOLUME OF PRODUCT IN COMMERCE 48.

DISTRIBUTION Nationwide, Spain and Luxembourg.

 

PRODUCT Benz Research and Development brand Extreme H20 Contact Lens, diopter -3.25, Base curve MED, Diameter 14.20.

CODE Lot number 8597006813.

RECALLING FIRM/MANUFACTURER Benz Research and Development Corp., Sarasota, FL

REASON Lenses may be labeled with an incorrect diopter power.

VOLUME OF PRODUCT IN COMMERCE 416/6 lens packs.

DISTRIBUTION FL and the United Kingdom, France, Switzerland and Germany.

 

Tri-State Hospital Supply Corp. Recalls Oral Swabs Due to Potential Choking Hazard

 

Tri-State Hospital Supply Corp. of Howell, MI, is recalling its Centurion® Mouth Care Kits that contain oral swabs because the sponge may become dislodged from the handle and potentially present a choking hazard. These products were distributed nationwide to hospitals after April 1, 2002 and consumers may have them home from a hospital or hospice and have them in their possession.

 

The oral swabs were contained in Mouth Care Kits produced under the following re-order numbers. Please note the asterisked (*) items were sold under the SHIELD Healthcare Center label as Enteral Feeding Kits:

SHIELD Healthcare Centers   24700 Avenue Rockefeller    Valencia, CA 91355

3599SB2
Lot #905062
Lot #906172

MC325
Lot #04082
Lot #904082
Lot #904222
Lot #906032

MC505
Lot #505202
Lot #507292
Lot #509032

MC605
Lot #07222
Lot #08122
Lot #508052
Lot #509232
Lot #503252
Lot #505272

 

 

 

 

 

 

3599XT1
Lot #904082
Lot #905062
Lot #905272

 

MC520
Lot #504152
Lot #504292
Lot #504082

 

MC370
Lot #505202
Lot #508262
Lot #507152

 

 

 

MC625
Lot #505272
Lot #509232

 

 

 

 

3599XT2
Lot #906032

 

MC540
Lot #904012
Lot #904222
Lot #905272
Lot #907292
Lot #908192

 

MC405
Lot #507152
Lot #508122

 

 

 

MC665
Lot #08122

 

H895
Lot #505132
Lot #506032
Lot #506172
Lot #507012

 

 

 

 

MC410
Lot #505202
Lot #508122

MC670
Lot #504152
Lot #505272
Lot #507152

 

 

 

MC550
Lot #504012
Lot #504292
Lot#507012

 

 

 

 

MC110
Lot #905272

MC420
Lot #504082
Lot #507082
Lot #509232

 

 

MC675
Lot #509162

 

 

 

 

MC110SB
Lot #908122
Lot #908262

MC585
Lot #507152
Lot #507292
Lot #509092

 

 

 

MC690
Lot #504152

 

MC440
Lot #04222
Lot #04292
Lot #06172
Lot #08192

 

 

 

 

MC120
Lot #904222
Lot #906242
Lot #907292

 

MC745
Lot #507292

 

MC590
Lot #504292
Lot #507082
Lot #507152

 

 

 

 

MC795
Lot #506172
Lot #508192
Lot #508262

 

 

MC445
Lot #505132
Lot #508032
Lot #508262

 

MC120SB
Lot #904292
Lot #907222

 

 

MC600
Lot #508122
Lot #509032
Lot #509092
Lot #509162

 

 

 

 

 

MC800
Lot #507012
Lot #507292
Lot #508052
Lot #508192
Lot #508262

 

MC200
Lot #05062
Lot #05202
Lot #06242
Lot #07292
Lot #09162
Lot #08192

MC465
Lot #906172
Lot #904152

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

The following kits are also included in this recall, but will not have lot numbers.

 

 

 

 

 

3599XT

ENTKIT6* 

MC340 

MC350 

MC755

ENTKIT1* 

ENTKIT7* 

MC390 

MC355 

MC785

ENTKIT12*

ENTKIT9* 

MC620 

MC655 

MC820

ENTKIT2* 

MC105 

MC105MG

MC660 

O80 

ENTKIT3* 

MC335 

MC320 

MC730 

 

The recall was initiated after it was discovered that the sponge from an oral swab had become dislodged and obstructed the patient's airway.

Consumers that may have removed the swabs from the hospital are urged to destroy the product, as they may present a potential choking hazard. Consumers with questions may contact Tri-State Hospital Supply Corp. at 1-800-248-4058.

 

WEEK ENDING NOVEMBER 16

 

PRODUCT Summit Autonomous Inc. LADAR Vision Excimer Lasers Systems, Ophthalmic Excimer Laser System.
CODE LADARVision Excimer Laser Systems with the following serial numbers were subject to this field corrective action: 17, 21, 22, 23, 26, 28, 30, 31, 32, 33, 34, 38-49, 1018, 1019, 1025, 1027, 1035, 1037, 1051-1053, 1055-1064, 1066-1079, 1081, 1083, 1085-1096, 1098-1105, 1109-1110, 1113, 1116, 1118-1020 and 1122.
RECALLING FIRM/MANUFACTURER Recalling Firm: Alcon Laboratories (formerly Summit Autonomous), Orlando, FL.
Manufacturer: Alcon Laboratories, Inc., Orlando, FL.
REASON Patient had unsatisfactory vision correction due to error in ablation mask function during Lasix treatmen.
VOLUME OF PRODUCT IN COMMERCE 85.
DISTRIBUTION Nationwide, Spain, Greece and Austrailia.

 

PRODUCT
2.8mm Drill Radiolucent Target
3.2mm Drill Radiolucent Target
3.7mm Drill Radiolucent Target
4.0mm Drill Radiolucent Target
4.3mm Drill Radiolucent Target
5.0mm Drill Radiolucent Target
5.5mm Drill Radiolucent Target
CODE Catalog No.

38152128

2.8mm Drill Radiolucent Target

38152132

3.2

38152137

3.7

38152140

4.0

38152143

4.3

38152150

5.0

38152155

5.5

RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ.
Manufacturer: Stryker Trauma, GmbH Kiel, Germany.
REASON Drill can penetrate blister package causing loss of sterility.
VOLUME OF PRODUCT IN COMMERCE 8436 units.
DISTRIBUTION Nationwide.

 

PRODUCT Allograft Heart Valve.
CODE Donor ID: 61611, Model Number: SGPV00, Allograft Serial Number: 7710510.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Marietta, GA.
REASON Donor post-mortem blood culture were positive for Clostridium septicum.
VOLUME OF PRODUCT IN COMMERCE 1 individual heart valve allograft.
DISTRIBUTION IN.

 

PRODUCT Multidiagnost 3 and Multidiagnost 4 X-Ray Systems: multi functional/universal system used for general R/F. Fluorscopy, radiography and angiography can be performed with other specialized interventional applications. Units involved have joysticks.
CODE Serial numbers as provided by the firm. The firm is verifying the accuracy of the serial numbers. MD 3 part #s 9896 000 12231, 9896 000 12232, 9896 000 12211, 9896 000 12212 Serial Nos. 4502681, 4543400, 4626120, 4706721, 4543410, 476793, 4492410, 4492330, 4533250, 4532940, 4533180, 459527, 4543470, 4502601, 4564170, 4533200, 4594941, 4595110, 4532870, 4584330, 4502791, 4492320, 4502731, 4533170, 4533230, 4533240, 4502611, 4502701, 4706541, 4706411, 25, 4562000, 4706421, 4543580, 4532880, 481854, 4615310, 4532990, 4757741, 4594861, 4767960, 4533120, 42012G, 4543721, 4615330, 4533030, 4533140, 4543751, 4726860, 4532910, 4595200, 4502771, 4595190, 4492400, 4706711, 4564180, 4452270, 4502591, 4543550, 4563950, 4615450, 4543590, 4492370, 4706370, 4626290, 4584490, 4533070, 4615390, 4543460, 4564090, 4543310, 4615430, 4564280, 4757420, 4502761, 4564070, 4767831.

MD 4 part #s 9896 000 58511, 9896 000 58512, 9896 000 58521, 9896 000 58522 Serial Nos. 4594911, 4564280, 4767891, 4757620, 13172S, 4757640, 4594980, 4595070, 4615511, 4615671, 4706481, 4595090, 4594871, 459500, 4625880, 4706471, 4706360, 4706691, 4757630, 459516, 4595240, 4595290, 4615320, 4615681, 4615641, 4625940, 4706521, 4626090, 4706571, 4584570, 4757731, 4626040, 4615360, 4626110, 4706641, 4584721, 4615581, 1, 4615751, 4584610, 4626250, 4727230, 4767911, 4727160, 4726940, 4726830, 4594841, 4626270, 4615790, 0, 4706390, 4706380, 4727010, 0, 4706881, 4757490, 4757590, 4757711, 4757300, 4768150, 476807-0400, 4818471,4767921, 4584520, 4818640, 4818311, 4768260, 4818620, 4818451, 4818441, 4768220, 4818570, 4818560, 4818590, 4584320, 4595130, 4615661, 4615761, 4706581, 4706751, 481861-0301.
RECALLING FIRM/MANUFACTURER Recalling Firm: Philips Medical Systems North America, Inc., Bothell, WA002.
Manufacturer: Philips Medical Systems, Netherlands,
REASON Potential for x-ray stand or table to move.
VOLUME OF PRODUCT IN COMMERCE MD3 - 77 units MD4 - 81 units.
DISTRIBUTION Nationwide.

 

PRODUCT AXIS/IRIX Gamma Camera Systems.
CODE Serial Numbers: 101 to 850.
RECALLING FIRM/MANUFACTURER Philips Medical Systems, Highland Heights, OH.
REASON The collimator latches may not fully engage when performing collimator exchanges.
VOLUME OF PRODUCT IN COMMERCE 747.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Depuy Ace brand Ace Trochanteric Nail, as follows:
Product 9032-11-225; 125 degree, 200mm X 11 mm.
Product 9032-11-230; 130 degree, 200mm X 11 mm.
Product 9032-11-240; 140 degree, 200mm X 11 mm.
Product 9032-13-225; 125 degree, 200mm X 13 mm.
Product 9032-13-230; 130 degree, 200mm X 13 mm.
Product 9032-13-240; 140 degree, 200mm X 13 mm.
CODE Product Lot
9032-11-225 WN1AH7
9032-11-230 WN2AA7 and WN2AB7
9032-11-240 WN1AL7
9032-13-225 WN1AJ7
9032-13-230 WN1AK7
9032-13-240 WN1AG7.
RECALLING FIRM/MANUFACTURER Depuy Orthopaedics, Inc., Warsaw, IN.
REASON May be packaged/etched with an incorrect neck angle.
VOLUME OF PRODUCT IN COMMERCE 296 pieces.
DISTRIBUTION Nationwide.

 

PRODUCT Steris Quick Connect Kits, catalog nos. #QCL1629 and #QLC1646. #QCL1629 is for Olympus 40/140/240 Series Non-Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray #QLC1646 is for Olympus 40/140/240 Series Duodenoscopes and Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing C1160 Tray
CODE Lot Numbers #3437936 and #343795, for Quick Connect Kit QLC1629; Lot Number #3438074, for Quick Connect Kit QLC1646.
RECALLING FIRM/MANUFACTURER Steris Corp., Mentor, OH.
REASON Incorrect adapter component may affect the sterilization process of scopes.
VOLUME OF PRODUCT IN COMMERCE 90 units.
DISTRIBUTION Nationwide and Australia.

 

PRODUCT Portable Automated External Difibrillators [AED] Model No. 9100-0100: a) AccessAED; b) AccessALS
CODE Model Number: 9100-0100  S/N's: 5212, 5886, 5887, 5888, 5889, 5943, 5944, 5945, 5946, 5421, 5422, 5426, , 5428, 5431, 5441, 5469, 5470, 5617, 5619, 5633, 5636, 5638, 5639, 5401, 5411, 5414, 5424, 5502, 5508, 5658, 5671, 5673, 5674, 5675, 5677, 5691, 5693, 5710, 5713, 5715, 5719, 5721, 5755, 5773, 5774, 5780, 5782, 5786, 5802, 5811, 5814, 5819, 5820, 5823, 5847, 5853, 5854, 5855, 5856, 5857, 5858, 5860, 5861, 5863, 5864, 5867, 5868, 5869, 5870, 5871, 5875, 5879, 5911, 5915, 5917, 5918, 5919, 5922, 5923, 5924, 5927, 5522, 5526, 5530, 5531, 5471, 5471, 5635, 5635, 5641, 5641, 5644, 5644, 5645, 5645, 5646, 5646, 5609, 5620, 5631, 5632, 5634, 5643, 5650, 5656, 5665, 5676, 5678, 5680, 5682, 5684, 5685, 5686, 5687, 5688, 5689, 5692, 5694, 5695, 5696, 5697, 5699, 5701, 5702, 5703, 5704, 5206, 5397, 5436, 5605, 5914, 5928, 5939, 5954, 5955, 5957, 5959, 5960, 5648, 5651, 5653, 5466, 5468, 5458, 5459, 5463, 5281, 5323, 5797, 5798, 5799, 5800, 5803, 5805, 5809, 5812, 5827, 5828, 5829, 5831, 5832, 5833, 5834, 5835, 5837, 5838, 5839, 5840, 5842, 5845, 5850, 5851, 5852, 5474, 5479, 5245, 5284, 5662, 5698, 5722, 5723, 5726, 5728, 5729, 5730, 5731, 5732, 5733, 5735, 5736, 5738, 5739, 5740, 5741, 5742, 5743, 5744, 5745, 5746, 5747, 5748, 5756, 5757, 5758, 5759, 5762, 5763, 5764, 5765, 5769, 5804, 5822, 5830, 5883, 5885, 5894, 5909, 5920, 5930, 5938, 5961, 5982, 5983, 5984, 5985, 5265, 5277.
RECALLING FIRM/MANUFACTURER Recalling Firm: Access Cardiosystems, Concord , MA.
Manufacturer: Access Cardiosystems Inc., Concord, MA
REASON Portable External Defibrilator May Fail Self Test and Fail to Function.
VOLUME OF PRODUCT IN COMMERCE 227.
DISTRIBUTION AZ, NY, MD, NV, OR, TX, WA, WI and Internationally.

 

PRODUCT Viscous Fluid Injector Pak (aka the VFI Pak), 10cc, an accessory to the Accurus Ophthalmic Surgical System

CODE VFI Pack, Catalog Number 8065740254, Lot numbers: 60004852, 60012226, 60042438, 60042790, 60055946, 60058700, 60058701, 60058923, 60073586, 60101513, 60101515, 60101517, 60135334, 60135335, 60162614, 60162618, 60167797, 60167800, 60167801, 60195239, 970160.
RECALLING FIRM/MANUFACTURER Alcon laboratories Houston, TX.
REASON Malfunction may result in the operator's inability to stop the flow of fluid already present in the needle portion of the device
VOLUME OF PRODUCT IN COMMERCE 81,000.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) NAMIC High Pressure Contrast Injection Line - 10" (25 cm); b) NAMIC Low Pressure Contrast Injection Line - 10" (25 cm).
Product description: The device is an extension between an angiographic catheter and an injector.
CODE 789657, Exp. 2003-02 ; 789951, Exp. 2003-02
RECALLING FIRM/MANUFACTURER Boston Scientific Corp., Glens Falls, NY.
REASON Product mix up. Low pressure line labeled High Pressure.
VOLUME OF PRODUCT IN COMMERCE 1000 units (500 high pressure lines + 500 low pressure lines).
DISTRIBUTION AZ, CO, GA, IN, MS, OK, VA and Canada.

 

PRODUCT Blood Glucose Test Strips - two (2) brands are involved: a) Genuine ONE TOUCH(TM), 50 Test Strips per unit carton. Unit carton labeled in part, "*** Genuine ONE TOUCH(TM) *** 50 TEST STRIPS *** For the quantitative measurement of glucose in whole blood *** For use with all ONE TOUCH(TM) Brand Glucose Meters *** LIFESCAN a Johnson & Johnson company Milpitas, California 95035 ***
LOT *** 53885 10631 (UPC #)***.

b) Uni-Check (TM) BLOOD GLUCOSE TEST STRIPS, 50 strips per unit carton. Unit carton labeled in part,"*** Uni-Check(TM) *** BLOOD GLUCOSE TEST STRIPS *** 50 Test Strips for Use with ONE TOUCH METERS *** 53885 10631 (UPC #)*** For Quantitative Measurement of Glucose in Whole Blood *** Produced for Diagnostic Solutions, Inc. Irvine, CA U.S.A. One Touch is a registered trademark of LifeScan Inc. a Johnson & Johnson company *** LOT ***. Outer carton containing 24 unit packages is labeled in part, *** UNI-CHECK TEST STRIPS *** CATALOG NO. 1702720 *** QTY: 24 PACKAGES of 50 STRIPS/PACKAGES *** LOT No.: *** EXPIRES: ***".
CODE All lots. Example of lots include: ONE TOUCH: UPC 53885-10631, Lot 158855A, EXP. 2003 - 11
Uni-Check: UPC 53885-10631, Lot No. 1208A5W, EXPIRES 18 JAN 2004; CATALOG NO. 1702720.
RECALLING FIRM/MANUFACTURER Payless Wholesale Inc., Glendale, NY.
REASON Products not approved for sale in USA & Canada, and may give inaccurate readings when used with readers from US & Canada.
VOLUME OF PRODUCT IN COMMERCE Unknown.
DISTRIBUTION OH, UT, MI and NY.

 

PRODUCT Premier HSV, an EIA diagnostic test kit, packaged under the Meridian Premier brand label.
CODE --- Premier HSV kits --- Lot Numbers and Exp. Dates: #550010.079, Exp. 02 Aug 02; #550010.080, Exp. 02 Aug 02; #550010.082, Exp. 26 Jul 02 --- OPD Substrate Tablets (kit component) --- Lot Number: 9677.043 The catalog number for the Premier HSV kit is #550010.
RECALLING FIRM/MANUFACTURER Meridian Bioscience, Inc., Cincinnati, OH.
REASON The OPD Substrate Tablets have deteriorated due to moisture, and may result in inaccurate test results.
VOLUME OF PRODUCT IN COMMERCE 594 kits (lot .079=330; lot .080=162; lot .082=102).
DISTRIBUTION Nationwide.

 

PRODUCT Hoffmann II Hybrid Ring Clamp Catalog No: 4936-2-010 Lot code: all manufacturing lot codes.
CODE Product: Hoffmann II Hybrid Ring Clamp Catalog No: 4936-2-010
Lot code: all manufacturing lot codes --J213338,J213339, J213347,J213348,J213349,J226523,J226524,J226526,J226527,J226528,J226532,J250574,J250580,J250584,J250595,J250724,J250742,J250780,J250781,J250789,J277290,J277292,J277293,J277294,J277295,J277296,J277304,J277305,J277306,J277308,J279332,J279333,J280162,J282104,J282107,J282108,J282109,J284516,J289305,J289310,J289344,J289345,J289346,J289347,J289348,J289359,J289445,J293624,J293626,J293627,J302150,J304357,J304358,J304359,J304360,J304361,J304362,J305847,J305848,J305849,J306173,J306188,J306946,J307905.
RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ.
Manufacturer: Stryker Trauma SA Geneva, Switzerland,
REASON The ring clamps may not tighten around post.
VOLUME OF PRODUCT IN COMMERCE 6342 pieces.
DISTRIBUTION Nationwide.

 

PRODUCT Medtronic Xomed "Cottle Mallet", a reuseable manual surgical instrument indicated for use in ENT (Nasal) surgical procedures.
Product is Catalog Number 37-14353 and some are contained in Kit Catalog Number 37-17008RF which is a nasal ENT surgical kit containing this mallet as a component and it is labeled as "Toriumi Set".
CODE Mallet lot numbers 24178300, 24449600 and 24469500 sold individually and also in the Toriumi Set kit lot numbers 16457 and 17529.
RECALLING FIRM/MANUFACTURER Xomed, Inc., Jacksonville, FL.
REASON Nylon Mallet head may deform when sterilized at insert parameters.
VOLUME OF PRODUCT IN COMMERCE 69 mallets with 39 of these in kits.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) MetriCide 14 Day, cold sterilant solution, 1 gallon; b) Gluteraldehyde NS, cold sterilant solution, 1 gallon.
CODE a) MetriCide 14 Day, Part number 10-1400, lot M630024; b) Gluteraldehyde NS, Part number 97-95483 (Metrex internal
part number 10-6800), lot M639460.
RECALLING FIRM/MANUFACTURER Recalling Firm: Sybron Dental Specialties, Inc., Orange, CA

REASON Cross-contamination with dissimilar steriliant.
VOLUME OF PRODUCT IN COMMERCE 2,107 cases 4-1 gallon bottles per case.
DISTRIBUTION Nationwide.

 

WEEK ENDING NOVEMBER 23

 

PRODUCT Steris Quick Connect Kits, catalog nos. #QCL1629 and #QLC1646.
#QCL1629 is for Olympus 40/140/240 Series Non-Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing Tray; and #QLC1646 is for Olympus 40/140/240 Series Duodenoscopes and Therapeutic GI Endoscopes in the STERIS SYSTEM 1 Sterile Processing System with the C1160 Universal Flexible Processing C1160 Tray.
CODE Lot Numbers #3437936 and #343795, for Quick Connect Kit QLC1629; Lot Number #3438074, for Quick Connect Kit QLC1646.
RECALLING FIRM/MANUFACTURER Steris Corp., Mentor, OH.
REASON Incorrect adapter component may affect the sterilization process of scopes.
VOLUME OF PRODUCT IN COMMERCE 90 units.
DISTRIBUTION Nationwide and Australia.

 

PRODUCT Invacare Venture HomeFill I Home Oxygen System.
CODE Models: IOH100 and IOH100RU Serial Numbers: 97A - 01L.
RECALLING FIRM/MANUFACTURER Recalling Firm: Invacare Corp., Elyria, OH.
REASON The high-pressure hose may separate from unit and cause injury to operator.
VOLUME OF PRODUCT IN COMMERCE 724.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT HFJV Patient Circuit Kit (Includes 2 ea. Circuits with 2 ea. 2.5mm and 2 ea. 3.5mm LifePort Endotracheal Tube Adapters) CAT: #937 Disposable - Single Patient Use Only. (Lots 2D0087, 2D0102, 2E0116, 2E0132, 2F0151, or 2G0155). Contained in these kits are Individual Life Pulse HFV Humidifier Cartridge Patient Breathing Circuits (Lots 2C0074, 2D0093, 2D0105, 2E0115, or 2E0118).
CODE HFJV Patient Circuit Kit Box Lot #'s 2DO087, 2DO102, 2EO116, 2EO132, 2FO151, 2GO155 containing Individual Life Pulse HFV Humidifier Cartridge Patient Breathing Circuit Lot #'s 2C0074, 2D0093, 2D0105, 2E0115, 2E0118.
RECALLING FIRM/MANUFACTURER Bunnell, Inc., Salt Lake City, UT.
REASON Reported failures of pinch tubing in Patient Circuit Kit.
VOLUME OF PRODUCT IN COMMERCE 845 units.
DISTRIBUTION Nationwide, Australia and Canada.

 

PRODUCT McGee Piston, Ossicular Replacement Prosthesis, Catalogue No.: 140332.
CODE 0211105284.
RECALLING FIRM/MANUFACTURER Gyrus ENT, LLC., Bartlett, TN.
REASON Lack of sterility assurance.
VOLUME OF PRODUCT IN COMMERCE 24.
DISTRIBUTION OH, LA, CA, NV, CO, DC, MN, MI, AK, RI, NY, United Kingdom and France.

 

PRODUCT 5 mm Preloaded AxyaLoop Titanium Bone Anchor in the following single or 3 driver kit configuration:
a) 5 mm Preloaded AxyaLoop Titanium Bone Anchor Polypropylene Suture, CAT#1221;
b) 5 mm Preloaded AxyaLoop Titanium Bone Anchor Nylon Suture, CAT#1227;
c) Mini-Open Rotator Cuff Procedural Kit,CAT#1501-3;
d) Arthroscopic Rotator Cuff Procedural Kit,CAT#1502-3;
e) Arthrocopic Rotator Cuff Procedural Kit, CAT#1506-3.
CODE a) Catalog Number: 1221 Lot Number: 201827, 202049
b) Catalog Number: 1227Lot Numbers: 201990, 201991
c) Catalog Number: 1501-3 Lot Numbers: 202051, 202066, 202183, 202192
d) Catalog NUmber: 1502-3 Lot Numbers: 202052, 202067, 202193
e) Catalog Number: 1506-3 Lot Number: 202138.
RECALLING FIRM/MANUFACTURER Axya Medical Inc., Beverly, MA.
REASON Driver Shaft May Break and Not Engage with Head of Anchor.
VOLUME OF PRODUCT IN COMMERCE 256.
DISTRIBUTION AZ, CA, MO, NV, NY, NJ, TX and VA.

 

PRODUCT RZ152 Digital Holter Recorder with Removable Flashcard. NOTE: the affected part was the 7-Lead cable, Part Number CBL-113.
RZ152 Digital Holter Recorder applications include 3-channel Holter recording for up to 48 hours. RZ152 can perform all three recording applications simultaneously.
CODE RZ 152R Digital Holter Recorder labeled as Rozinn with 7-Lead cables, Part Number CBL-113 (a component to the recorder).
RECALLING FIRM/MANUFACTURER Rozinn Electronics, Inc., Glendale, NY.
REASON RZ 152 Digital Holter Recorders were distributed with defective lead cables.
VOLUME OF PRODUCT IN COMMERCE 31 units worldwide: 24 units within USA; 7 units to foreign accounts in Chile, China, Italy, Poland, Germany & Venezuela.
DISTRIBUTION NY, CA, MI, OH, NM and Puerto Rico, Chile, China, Italy, Poland, Germany and Venezuela.

 

PRODUCT Davol EndoAvitene Microfibrillar Collagen Hemostat.
CODE Product Code: 1010260 Lot Number: 52CMND12.
RECALLING FIRM/MANUFACTURER Davol Inc., Subsidiary of C. R. Bard Inc., Cranston, RI.
REASON Device not manufactured in conformance with the Device Master Record.
VOLUME OF PRODUCT IN COMMERCE 645 units.
DISTRIBUTION Nationwide and Belgium.

 

PRODUCT Narkomed 6000 (NM6000), Anesthesia Machines, Catalog Numbers 4114586-001 and 4116660.
CODE Serial numbers distributed in US: 10864, 11006, 11009, 11066, 11067, 11069, 11071, 11072, 11073, 11074, 11075, 11076, 11077, 11078, 11079, 11080, 11081, 11082, 11083, 11085, 11086, 11087, 11088, 11089, 11090, 11091, 11092, 11095, 11096, 11097, 11098, 11099, 11101, 11106, 11107, 11108, 11109, 11110, 11111, 11112, 11113, 11117, 11118, 11119, 11120, 11121, 11122, 11123, 11124, 11125, 11127, 11128, 11129, 11130, 11131, 11132, 11133, 11134, 11136, 11138, 11139, 11140, 11141, 11142, 11143, 11144, 11145, 11146, 11147, 11149, 11150, 11151, 11152, 11153, 11154, 11155, 11156, 11157, 11158, 11159, 11160, 11161, 11166, 11167, 11168, 11169, 11170, 11171, 11172, 11173, 11174, 11179, 11180, 11182, 11183, 11184, 11185, 11186, 11187, 11188, 11189, 11190, 11191, 11192, 11193, 11194, 11204, 11207, 11220, 11229, 11234, 11235, 11244, 11245, 11248, 11249, and 11250.

Serial numbers distributed in Canada: 10141, 10143, 10146, 10511, 10645, 10684, 10685, 10771, 10775, 10786, 10787, 10788, 10789, 10797, 10798, 10819, 10820, 10821, 10822, 10823, 10825, 10827, 10828, 10829, 10830, 10831, 10833, 10835, 10837, 10839, 10841, 10843, 10844, 10852, 10860, 11115, and 11116.
RECALLING FIRM/MANUFACTURER Draeger Medical Inc., Telford, PA.
REASON Malfunction - sparks and smoke.
VOLUME OF PRODUCT IN COMMERCE 154 units.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT In-Health Blom-Singer Humidifier Holder, Cat. No. BE1060.
CODE Lot Number 667623. Catalog Number BE 1060.
RECALLING FIRM/MANUFACTURER Helix Medical, Inc., Carpinteria, CA.
REASON Mispackaging. Caps were labeled as holders.
VOLUME OF PRODUCT IN COMMERCE 36.
DISTRIBUTION CA, CT, PA, GA, KY and Italy and Germany.

 

WEEK ENDING NOVEMBER 30

 

PRODUCT  The following products under the Centurion Healthcare Products brand:
Oral Swabs, Sodium Bicarb Treated, 2/Pkg., 800/case.
Latex-free. Reorder 3599SB2.

10/Pkg. Sodium Bicarb Oral Swabs, 100 per case. Reorder MC110SB.

20/Pkg. Sodium Bicarb Oral Swabs, Rorder MC120SB.

Admission Kits. Reorder H895.

Large Oral Swabs, 4000/case. Reorder 3599XT.

Plain Oral Swab, 1/package, 800/case, latex-free. Reorder 3599XT1.

Oral Swabs, 2/Package, 800/case. Latex-free. Reorder 3599XT2.

Mouth Care Kit, latex-free [contents 5 oral swabs], 100 per case. Reorder MC105.

Mouth Care Kit 5/pkg., latex-free [contents 5 plain oral swabs], 100 per case. Reorder MC105MG.

10/Pkg. plain Oral Swabs, 4 dispenser packs of 25 bags. Reorder MC110.

20/Pkg. Plain Oral Swabs; 50 pkgs per case. Reorder MC120.

Mouth Care Kit, latex-free [contents lip balm, mouth rinse, oral swabs]. Reorder: MC200.
Mouth Care Kit, latex-free [contents lip moisturizer, mouth rinse, plain oral swabs]. Reorder MC320.

Mouth Care Kit, latex-free [contents mouth rinse, medicine cup, mouth moisturizer, sodium bicarb oral swabs]. Reorder MC325.

The Medical Center Mouthcare Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC335.

Mouth Care Kit, latex-free [contents medicine cup, toothpaste, mouthwash, mouth moisturizer, oral swabs]. Reorder: MC340.

Large Mouth Care Kit, latex-free [contents oral swabs, mouth rinse, mouth moisturizer]. Reorder MC350.

Small Mouth Care Kit, latex-free [contents mouth rinse, oral swabs]. Reorder: MC355.

Mouth Care Kit, latex-free [contents mouth rinse - mint flavored, mouth moisturizer, mouthwash and oral swabs]. Reorder: MC370.

Mouth Care Kit, latex-free [contents mouth moisturizer, toothpaste, mouth rinse, plain oral swabs]. Reorder: MC390.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs. Reorder MC405.

Mouth Care Kit, latex-free [contents toothpaste, toothbrush, mouth moisturizer, mouthwash, oral swabs]. Reorder: MC410.

Mouth Care Kits, latex-free [contents mouth moisturizer, mouth rinse, medicine cup, oral swabs]. Reorder: MC420.

Mouth Care Kits, latex-free [contents mouth moisturizer, toothpaste, mouthwash, oral swabs]. Reorder MC440.

Mouth Care Kits, latex-free [contents mouth moisturizer, mouth rinse, toothpaste, oral swabs]. Reorder: MC445.

Mouth Care Kit [contents 5 oral swabs], 50 per case. Reorder MC465.

Short Term Mouth Care Kit, latex-free [mouthwash and plain oral swabs]. Reorder: MC505.

Mouth Care Kit, latex-free [contents lip moisturizer, mouthwash, oral swabs]. Reorder MC520.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC540.

Oral Care Kit, latex-free [contents mouth moisturizer, mouthwash, oral swabs]. Reorder: MC550.

Mouth Care Kit with Suction-Swabstick, latex-free [contents mouth moisturizer, oral swabs, mouth care kits]. Reorder: MC585.

Mouth Care Protocol Kit, latex-free [contents large oral swabs, mouth moisturizer, mouth care kit]. Reorder: MC590.

Mouth Care Kit, latex-free [contents toothbrush, toothpaste, mouth moisturizer, peroxide, oral swabs]. Reorder: MC600.

Mini Mouth Care Kits, latex-free [contents peroxide and sodium bicarb swabs], 50 per case. Reorder MC605.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinses, toothpaste, oral swabs]. Reorder: MC620.

Mouth Care Kit, latex-free [contents mouth rinse, mouth moisturizer, plain oral swabs]. Reorder: MC625.

Mouth Care Kit, latex-free [contents mouth rinse, mouth
moisturizer, medicine cup, plain oral swabs]. Reorder: MC655.

Mouth Care Kit, latex-free [contents mouth moisturizer, medicine cups, mouthwash, sodium bicarb swabs]. Reorder: MC660.

Mouth Care Kit with Plain Swabs, latex-free [contents mouth
moisturizer, mouth rinse, toothpaste plain oral swabs]. Reorder: MC665.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouthwash, sodium bicarb oral swabs]. Reorder: MC670.

Mouth Care Kit with SofTouch Suctioning Swab [contents toothpaste, mouth moisturizer, mint flavored 1.5% hydrogen peroxide mouth rinse, disposable suction device, plain oral swabs]. Reorder: MC675.

Mouth Care Kit, latex-free [contents large oral swabs, mouth rinse, toothpaste]. Reorder: MC690.

Mouth Care Kit, latex-free. [contents 8 plain oral swabs]. Reorder MC730.

Mouth Care Kit, latex-free [contents mouth rinse and plain oral swabs]. Reorder: MC745.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouthwash, plain oral swabs]. Reorder: MC755.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC785.

Mouth Care Kit with SofTouch Suctioning Swab [contents mouth moisturizer, lip moisturizer, mouth rinse, disposable suction device, plain oral swabs]. Reorder: MC795.

Mouth Care Kit with SofTouch Suctioning Swab [contents mouth moisturizer, mint flavored 1.5% hydrogen peroxide mouth rinse, disposable suction devices, plain oral swab]. Reorder: MC800.

Mouth Care Kit, latex-free [contents mouth moisturizer, mouth rinse, oral swabs]. Reorder: MC820.

Mouth Care Kit, latex-free [contents medicine cup, lip moisturizer, mouth rinse, plain oral swabs]. Reorder: O80.

The following products under the Shield Healthcare Centers brand:
Code No. ENTKIT 1 Enteral Feeding Kit (Bolus) [Contents syringes, sponges, oral care kits, tape, wipes, cath plugs].

Code No. ENTKIT 2 Enteral Feeding Kit (Bolus) [Contents syringes, sponges, tape, cream, wipes, cath plugs, periwash, oral care kits].

Code No. ENTKIT 3 Enteral Feeding Kit (Bolus) [Contents syringes, sponges, tape, cream, wipes, cath plugs, periwash, oral care kits].

Code No. ENTKIT 6 Enteral Feeding Kit (Gravity) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips].
Code No. ENTKIT 7 Enteral Feeding Kit (Gravity) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips].

Code No. ENTKIT 9 Enteral Feeding Kit (Pump) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips, cath plugs].

Code No. ENTKIT 12 Enteral Feeding Kit (Pump) [Contents feeding bags, syringes, sponges, tape, cream, wipes, periwash, oral care kits, Q-tips, cath plugs].
CODE
Reorder 3599SB2. Lots 905062 and 906172.

Reorder MC110SB. Lots 908122 and 908262.

Rorder MC120SB. Lots 904292 and 907222.

Reorder: H895. Lots 505132, 506032, 506172 and 507012.

Reorder: 3599SB2. Lots 905062 and 906172.

Reorder: 3599XT. All swabs distributed after April 1, 2002. [do not bear lot numbers].

Reorder: 3599XT1. Lots 904082, 905062 and 905272.

Reorder: 3599XT2. Lot 906032.

Reorder: MC105. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC105MG. All kits distributed after April 1, 2002[do not bear lot numbers].

Reorder: MC110. Lot 905272.

Reorder: MC110SB. Lots 908122 and 908262.

Reorder: MC120. Lots 904222, 906242 and 907292.

Reorder: MC120SB. Lots 904292 and 907222.

Reorder: MC200. Lots 05062, 05202, 06242, 07292, 09162 and 08192.

Reorder: MC320. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC325. Lots 04082, 904082, 904222 and 906032.

Reorder: MC325. Lots 04082, 904082, 904222 and 906032.

Reorder: MC335. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC340. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC350. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC355. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC370. Lots 505202, 508262 and 507152.

Reorder: MC390. All kits distributed after April 1, 2002 [do not bear lot numbers].
Reorder: MC405. Lots 507152 and 508122.

Reorder: MC410. Lots 505202 and 508122.

Reorder: MC420. Lots 504082, 507082 and 509232.

Reorder: MC440. Lots 04222, 04292, 06172 and 08192.

Reorder: MC445. Lots 505132, 508032 and 508262.

Reorder: MC465. Lots 906172 and 904152.

Reorder: MC505. Lots 505202, 507292 and 509032.

Reorder: MC520. Lots 504152, 504292 and 504082.

Reorder: MC540. Lots 904012, 904222, 905272. 907292 and 908192.

Reorder: MC550. Lots 504012, 504292 and 507012.

Reorder: MC585. Lots 507152, 507292 and 509092.

Reorder: MC590. Lots 504292, 507082 and 507152.

Reorder: MC600. Lots 508122, 509032, 509092 and 509162.

Reorder: MC605. Lots 07222, 08122, 508052, 509232, 503252 and 505272.

Reorder: MC620. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC625. Lots 505272 and 509232.

Reorder: MC655. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC660. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC665. Lot 08122.

Reorder: MC670. Lots 504152, 505272 and 507152.

Reorder: MC675. Lot 509162.

Reorder: MC690. Lot 504152.

Reorder: MC730. All kits distributed after April 1, 2002 [do not bear lot numbers].

Reorder: MC745. Lot 507292.

Reorder: MC755. All kits distributed after April 1, 2002 [do not bear numbers].

Reorder: MC785. All kits distributed after April 1, 2002 [do not bear numbers].

Reorder: MC795. Lots 506172, 508192 and 508262.

Reorder: MC800. Lots 507012, 507292. 508052, 508192 and 508262.

Reorder: MC820. All kits distributed after April 1, 2002 [do not bear numbers].

Reorder: O80. All kits distributed after April 1, 2002 [do not bear numbers].

Code No. ENTKIT 1. All kits distributed after April 1, 2002 [do not bear numbers].

Code No. ENTKIT 2. All kits distributed after April 1, 2002 [do not bear numbers].

Code No. ENTKIT 3. All kits distributed after April 1, 2002 [do not bear numbers].

Code No. ENTKIT 6. All kits distributed after April 1, 2002 [do not bear numbers].
Code No. ENTKIT 7. All kits distributed after April 1, 2002 [do not bear numbers].

Code No. ENTKIT 9. All kits distributed after April 1, 2002 [do not bear numbers].

Code No. ENTKIT 12. All kits distributed after April 1, 2002 [do not bear numbers].
RECALLING FIRM/MANUFACTURER Recalling Firm: Tri-State Hospital Supply Corp., Howell, MI.
REASON The sponge may become dislodged from the oral swab and present a choking hazard.
VOLUME OF PRODUCT IN COMMERCE 92,330 kits.
DISTRIBUTION Nationwide.

 

PRODUCT Bard LUMINEXX 7F Biliary Stent and Delivery System (length 60 cm);
Bard LUMINEXX 7F Vascular Stent and Delivery System (length 60 and 120 cm);
Bard LUMINEXX 7F Biliary Stent and Delivery System (length 80 and 120 cm);
memotherm-FLEXX Biliary Stent and Delivery System (length 60 cm);
memotherm-FLEXX Biliary Stent and Delivery System (length 80 and 120 cm);
memotherm-FLEXX Vascular Stent and Delivery System (length 60 and 120 cm).
CODE All lots produced.
RECALLING FIRM/MANUFACTURER Recalling Firm: Bard Peripheral, Vascular Tempe, AZ.
Manufacturer: Division IMPRA Medica Munich, Germany.
REASON Sterile barrier compromised.
VOLUME OF PRODUCT IN COMMERCE 36,386.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT UroMax Ultra High Pressure Balloon Dilatation Catheters with HydroPlus Coating (kits) as follows:
a) UroMax Ultra Balloon Dilatation Catheters U2q/4-4/6/75, 10CC LWIG Kit, Catalog Number: 622512;
b) UroMax Ultra Balloon Dilatation Catheters U2q/8-8/6/75, 10CC LWIG Kit,Catalog Number: 622513.
CODE a) Lot Number: 821010; b) Lot Number: 823775.
RECALLING FIRM/MANUFACTURER Recalling Firm: Boston Scientific Corp./Microvasive Urology, Div. Natick, MA.
Manufacturer: Boston Scientific Corp., Glens Falls, NY.
REASON Mislabeled: The unit carton for the UroMax Ultra 8mm-8cm kit contained a 4mm-4cm Balloon Catheter, and the UroMax Ultra 4mm-4cm kit contained a 8mm-8cm Balloon Catheter.
VOLUME OF PRODUCT IN COMMERCE 36 kits.
DISTRIBUTION Nationwide.

 

PRODUCT a) Endeavor 16-channel Neuromonitoring System; b) VikingSelect 2, 4 or 8-channel Neuromonitoring System.
CODE All lots produced.
RECALLING FIRM/MANUFACTURER Nicolet Biomedical, Madison, WI.
REASON Amplifiers used in the Endeavor and 8-channel VikingSelect Neuromonitoring Systems have a slow recovery from electrocautery so that physiologic signal monitoring can be delayed by up to several minutes.
VOLUME OF PRODUCT IN COMMERCE a) 264; b) 371.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT a) ExpressView Glucose 50 Test Strips, part Number 20025 is packaged 50 strips per vial and the vial is shrink wrapped. There is no outer carton/package;
b) In Charge Glucose Value pack, Part Number 30008 contains two vials of 25 glucose test strips (for a total of 50 glucose test strips) and one vial of 4 GlucoProtien test strips in one outer package/carton. (note: the GlucoProtein Test Strips contained in the In Charge Value Pack were previously recalled under recall numbers Z-103-3 and Z-104-3.);
c) In Charge Glucose 50 Test Strips, Part Number 20005 contains two vials of 25 glucose test strips (for a total of 50 glucose test strips) in one outer package/carton.
CODE a) Lot numbers 200250700833, 200250700825, 200250700798; b) and c) Lot number 80120700790.
RECALLING FIRM/MANUFACTURER LXN Corporation, San Diego, CA.
REASON Stability failure.
VOLUME OF PRODUCT IN COMMERCE 17298.
DISTRIBUTION Nationwide.

 

PRODUCT Brand Name: ACS:180(R) Automated Chemiluminescence System Valproic Acid. Common Name: ACS:180(R) Valproic Acid:
a) Catalog/Part Number 129216, 50 tests total: Contents: 1 vial of ACS:180 Valproic Acid Lite Reagent, 1 vial of ACS:180 Valproic Acid Solid Phase, ACS:180 Valproic Acid Master Curve Card;
b) Catalog/Part Number 129217, 300 tests total: Contents: 6 vials of ACS:180(R) Valproic Acid Lite Reagent, 6 vials of ACS:180 Valproic Acid Solid Phase, ACS:180 Valproic Acid Master Curve Card.
CODE a) Kit Lot Numbers 1987402, 2123203,2244103, 2308303, 2402804;
b) Catalog/Part # 129217: Kit Lot Numbers 1987502, 2123303, 284703, 2411704.
RECALLING FIRM/MANUFACTURER Bayer Corporation, Business Group Diagnostics, Tarrytown, NY.
Manufacturer: Bayer Diagnostics, East Walpole, MA.
REASON Photo-oxidation of the ACS:180 Valproic Acid reagent has occurred due to inadequate instructions for storage.
VOLUME OF PRODUCT IN COMMERCE a) 202 units; b) 59 units.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Geo-Inserter for spinal implants, Catalog No. 1000-9015.
CODE Lot 30963.
RECALLING FIRM/MANUFACTURER Interpore Cross Intl., Irvine, CA.
REASON Tips break while surgeon is seating implant.
VOLUME OF PRODUCT IN COMMERCE 11.
DISTRIBUTION LA, GA, OH, NJ, WI and MO.

 

PRODUCT T2 Screwdriver 3.5, extra short; T2 Screwdriver Bit, short; T2 Screwdriver bit, long; T2 Screwdriver, long; T2 Screwdriver, short;
T2 Compression Screwdriver Bit; T2 Screwdriver Shaft; Orthopedic Manual Surgical Instrument.
CODE All tips under each Catalog Number.
RECALLING FIRM/MANUFACTURER Recalling Firm: Howmedica Osteonics Corp., Rutherford, NJ.
Manufacturer: Stryker Trauma GmbH Kiel, Germany.
REASON The screwdrivers might be susceptible to intra-operative breakage at tip.
VOLUME OF PRODUCT IN COMMERCE 1238.
DISTRIBUTION Nationwide.

 

PRODUCT Quest Myocardial Protection System Back-up Set (MPSBUS), packaged within two molded-foam halves with the handle in a shipping box. Instructions are place directly on the unit. Two disposable individually wrapped, sterile, pressure-monitor parts are included in a secondary box.
CODE Catalog number 5001015  Serial Numbers 1032 through 1037.
RECALLING FIRM/MANUFACTURER Quest Medical, Inc., Allen, TX.
REASON Wrong size Roll pin (part), could cause the belt tensioner to disengage and result in stop of fluid flow during surgery.
VOLUME OF PRODUCT IN COMMERCE 6 units.
DISTRIBUTION PA, IL and Kuwait.

 

PRODUCT Little Soothers. Classification Name: Cold Pack, The Little Soother is a 3 inch by 2 inch sealed plastic patch containing several ingredients including propylene glycol. The propylene glycol in the Little Soother acts to keep the device cool when the device is chilled. It was manufactured in three shapes: a yellow fish, a pink butterfly, and a blue penguin. There are 3 patches per unit container labeled in part, "xxx LITTLE SOOTHERS SET OF THREE xxx AVON wellness xxx".
CODE Patches are not coded. Avon identifies the product under Style # FSC: F68115-1 which is also found on the back of the unit container. Little Soothers are featured in campaigns 16-18 (wellness What's New Extra).
RECALLING FIRM/MANUFACTURER Recalling Firm: Avon Products, Inc., New York, NY.
Manufacturer: Won Yong, South Korea.
REASON The product contains ethylene glycol instead of propylene glycol.
VOLUME OF PRODUCT IN COMMERCE 1129 units containing three (3) Little Soother patches each.
DISTRIBUTION Nationwide.

 

PRODUCT Hill-Rom brand Affinity Three birthing bed.
CODE All beds with calf supports distributed between August 8, 2001 and September 18, 2002.
RECALLING FIRM/MANUFACTURER Hill-Rom, Inc., Batesville, IN.
REASON Calf support may become unstable.
VOLUME OF PRODUCT IN COMMERCE 200.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT AMPLATZER Delivery Systems.
7 French, Order Number 9-DEL-7F-45/80;
8 French, Order Number 9-DEL-8F-45/80;
9 French, Order Number 9-DEL-9F-45/80;
9 French, Order Number 9-DEL-9F-45/100;
10 French, Order Number 9-DEL-10F-45/80;
10 French, Order Number 9-DEL-10F-45/100;
12 French, Order Number 9-DEL-12F-45/80;
12 French, Order Number 9-DEL-12F-45/100.
b) AMPLATZER Exchange Systems: 12 French, Order Number 9-EXCH-12F-45/80.
CODE AMPLATZER Delivery Systems.
RECALLING FIRM/MANUFACTURER AGA Medical Corporation, Golden Valley, MN.
REASON Smaller than specified delivery cable screw diameter can lead to separation of device from delivery cable.
VOLUME OF PRODUCT IN COMMERCE 14910 AMPLATZER Delivery or Exchange Systems.
DISTRIBUTION Nationwide and Internationally.

 

PRODUCT Accura Hemo Filtration Device, catalog #5M5660.
CODE Catalog #5M5660 and Accura 01, serial numbers 0140, 0141, 0142, 0143, 0144, 0145, 0146, 0147, 0148, 0149, 0190, 0191, 0192, 0193, 0194, 0195, 0196, 0197, 0198, 0199, 0272, 0273, 0283, 0284, 0285, 0330, 0331, 0332, 0333, 0340, 0341, 0358, 0359, 0360, 0361, 0421, 0422, 0423, 0424, 0425, 0426, 0450, 0451, 0452, 0453, 0454, 0455, 0456, 0457, 0458, 0459, 0460, 0461.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Deerfield, IL.
Manufacturer: MeSys GmbH (Medizinische Systeme) Hanover.
REASON Blood leaks from the blood pump segment of the tubing set.
VOLUME OF PRODUCT IN COMMERCE 53 units.
DISTRIBUTION Internationally.

 

PRODUCT Monopolar needle electrode: disposable, sterile monopolar needle electrode used in electromyography (EMG) studies. Electromography is the measurement of skeletal muscle nerve activity.
Product is packaged and labeled in part "CADWELL Monopolar EMG Needle Electrodes Disposable/Pre-Sterilized ** 10 needles/package.
CODE Cadwell P/N: 202207-000, 202208-000, 202704-000, 202209-000, 202210-000; Lot numbers: 1201XXX, 0202XXX, 0402XXX, 0602XXX, 0802XXX, 0102XXX, 0302XXX, 0502XXX, 0702XXX, 0902XXX.
RECALLING FIRM/MANUFACTURER Recalling Firm: Cadwell Laboratories, Inc., Kennewick, WA.
Manufacturer: Jari Electrodes, Gilroy, CA.
REASON Inconsistent electrical performance of monopolar emg needles.
VOLUME OF PRODUCT IN COMMERCE 13,387.
DISTRIBUTION Nationwide and Internationally.