APRIL 2003

 

WEEK ENDING APRIL 12


PRODUCT Fetal Cell Stain Kit No. S0412-00, contents include 3 x 120ml Fetal Cell Fixing Solution 80% Reagent Alcohol), 3 x 120ml Fetal Cell Citrate Buffer Solution (Citrate Buffer, 0.081M), and 3 x 120ml Fetal Cell Stain (Erythrosin-B, Fast Green).
CODE Lot #92558, Exp. March, 2004.
RECALLING FIRM/MANUFACTURER Simmler, Inc., St Louis, MO,

REASON Fixing solution bottles are labeled as buffering solution.
VOLUME OF PRODUCT IN COMMERCE 352 kits.
DISTRIBUTION Nationwide, Canada, and Japan.

PRODUCT
a) Digene's Hybrid Capture 2 HPV DNA Test, Catalog # 5101-1096.
b) Digene's Hybrid Capture 2 HPV DNA Test, Catalog # 5196- 1230, labeled for export only.
c) Hybrid Capture 2 high-Risk HPV DNA Test, Catalog # 5101-1296.
d) Hybrid Capture II CT-ID Twst, Catalog # 5135-10501VT, (labeled for export only).

CODE
a) Lot 2447/exp 2004-01; Lot 2476/exp 2003-08-14; Lot 2569/exp 2003-09-24; Lot 2570/exp 2003-11; Lot 2577/exp 2003-09-24;

Lot 2646/exp 2003-08;
b) Lot 2759/exp 2003-08-31;
c) Lot 2436/exp 2003-11;
d) Lot 2443/exp 2002-12-02.
RECALLING FIRM/MANUFACTURER Digene Corp., Gaithersburg, MD,

REASON In Vitro diagnostic test kit may produce false positive patient results.
VOLUME OF PRODUCT IN COMMERCE
a) 1,858 kits/96 assays per kit;
b) 848 kits/96 assays per kit;
c) 831 kits/96 assays per kit;
d) 272 kits/96 assays per kit.
DISTRIBUTION Nationwide and Internationally.

PRODUCT Flexgard, off-the-shelf knee brace, product number 14761106.
CODE Lot numbers 53078 and 53985.
RECALLING FIRM/MANUFACTURER DeRoyal Industries, San Luis Obispo, CA,

REASON Manufacturing defect possibly causing screws to come loose causing the brace to collapse during use.
VOLUME OF PRODUCT IN COMMERCE 13.
DISTRIBUTION ID, CA, NC, TX, SC, NM, GA, and TN.

PRODUCT TPS-TL Straight Drill Guide Applicator, Catalog Number 1300-9016.

CODE Lot 32688.
RECALLING FIRM/MANUFACTURER Interpore Cross International, Inc., Irvine, CA,

REASON Instrument fell apart during cleaning prior to surgery.
VOLUME OF PRODUCT IN COMMERCE 39.
DISTRIBUTION Nationwide and Internationally.

PRODUCT
a) Baxter SPS 550 Single Patient System Hemodialysis  Machine.;
b) Baxter 1550 Single Patient System Hemodialysis Machines.
CODE
a) Catalog numbers: 5M1309, 5M1309R, 5M1310, 5M1310R, 5M5506, 5M5506R, 5M5507, 5M5507R, 5M5516, 5M5516R, 5M5518, 5M5518R, 5M5533, 5M5536, FM4649, FM4654, FM4714, FM4796R, FM4797; all serial numbers;
b) Catalog numbers: 5M5538, 5M5538R, 5M5551, 5M5551R,5M5575, FM4719, FM4774, FM4779, FM4779R; all serial numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Baxter Healthcare Corp., Round Lake, IL,

Manufacturer: Baxter Healthcare Corp., Deerfield, IL. Firm initiated recall is ongoing.
REASON Excess or insufficient ultrafiltration may occur during manual control of ultrafiltration via adjustment of transmembrane pressure (TMP).
VOLUME OF PRODUCT IN COMMERCE 17,322 units.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Product is labeled as "Oto-Flex Bur", Medtronic-Xomed brand, packed into a sterile pouch. Product is further packaged into a shelf box with similar labeling as follows: Part Number 31-55631 Oto-Flex carbide 1.0mm Bur; Part Number 31-55632 Oto-Flex carbide 2.3mm Bur; Part Number 31-55642 Oto-Flex diamond 2.3mm Bur; Part Number 31-55647 Oto-Flex diamone 0.7 mm Bur. Part Number and Lot Number is listed on pouch and box label.

CODE Part No. 31-55631, lot number 27066500 Part No. 31-55632, lot number 27111700 Part No. 31-55642, lot number 27135800
Part No. 31-55647, lot number 27123300.
RECALLING FIRM/MANUFACTURER Medtronic Xomed, Inc., Jacksonville, FL,

REASON Product packaging pouches may be open thereby compromising the sterile barrier.
VOLUME OF PRODUCT IN COMMERCE 120.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Stretta brand Catheter and Accessory Kit, Part # 175-2575. Model 4301K.

CODE FD1268 thru FD1282.
RECALLING FIRM/MANUFACTURER Curon Medical, Inc., Sunnyvale, CA.,

REASON Catheter shaft has potential to crack during use.
VOLUME OF PRODUCT IN COMMERCE 326 units.
DISTRIBUTION Nationwide.


PRODUCT Sarns MP4 Cardioplegia Sets; catalog number 15501.
CODE Lot 322125.
RECALLING FIRM/MANUFACTURER Terumo Cardiovascular Systems Corp.
REASON There is a potential for delivery of a lower than intended amount of cardioplegia solution to the heart during surgery.
VOLUME OF PRODUCT IN COMMERCE 300.
DISTRIBUTION Nationwide.

 

PRODUCT Misys Laboratory System Version 5.3.

CODE Version 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ,

REASON Software anomaly. The HIDE command used to suppress suspected individual microbiology observations does not work in GUI inquiry.
VOLUME OF PRODUCT IN COMMERCE 464.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Permobil Chairman 2K powered wheelchair, Model 1280.
CODE Serial Numbers: 1100068 to 1103702.
RECALLING FIRM/MANUFACTURER Permobile, Inc., Lebanon, TN,

REASON Incidents were reported where a drive wheel has come off its motor axle, due either to loosening of the wheel bolt or a broken wheel bolt.
VOLUME OF PRODUCT IN COMMERCE 1582.
DISTRIBUTION Nationwide, Puerto Rico, and Canada.

PRODUCT CryoValve Allograph, Heart valve.

CODE Donor #60084, Serial #7769926, Model #PV00 and Donor #55139, Serial #7165235, Model #SGPV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc.,Kennesaw, GA,

REASON Microorganisms were detected in distributed allografts.
VOLUME OF PRODUCT IN COMMERCE 2 units.
DISTRIBUTION OK, British Columbia, and Canada.


PRODUCT CryoValve Allograft, heart valve.

CODE Donor #61266, Serial # 7701969, Model #AV00;  Donor #63307, Serial #7899279, Model # SGAV00; Donor #64489, Serial #7869356, Model # SGPV00; Donor #65674, Serial # 7957300 Model #SGPV00; Donor #64879, Serial # 7883273, Model #SGPV00; Donor #64697, Serial #7876274, Model #PV00.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA,
REASON Microorganisms were detected in distributed donor tissue.
VOLUME OF PRODUCT IN COMMERCE 6.
DISTRIBUTION CA, MD, ME, and SD.


PRODUCT ECAT Software Versions V7.1.1b, V7.2, V7.2.1, and V7.2.2 used in the following PET (Positron Emission Tomography) systems:

Siemens Models: ECAT EXACT, ECAT EXACT HR, ECAT EXACT HR+, ECAT ART, ECAT EMERGE and ECAT ACCEL CTI Models: ECAT EXACT, ECAT EXACT HR+, ECAT ART, ECAT EMERGE, ECAT ACCEL, REVEAL QS and REVEAL XL Marconi Models: Magellan

Hitachi Models: Sceptre and Sceptre XL.

CODE All serial numbers of above indicated scanner models using ECAT System Software Versions V7.1.1b, V7.2, V7.2.1 and V7.2.2.
RECALLING FIRM/MANUFACTURER Cti Pet Systems, Inc., Knoxville, TN,

REASON Incorrect patient information is displayed in the reconstructed images of a whole body patient scan.
VOLUME OF PRODUCT IN COMMERCE 444.
DISTRIBUTION Nationwide and Internationally.


PRODUCT CryoValve Allograft heart valve.

CODE Model number SGPV00, Serial Number: 7291867, Donor #55899.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA

REASON An allograft associated with this donor has been linked to an alleged infection.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION IN.


PRODUCT CryoValve Allograft heart valve.

CODE Model number PV00, Serial Number: 7255205, Donor #56190.
RECALLING FIRM/MANUFACTURER Cryolife, Inc., Kennesaw, GA,

REASON An allograft associated with this donor has been linked to an alleged infection.
VOLUME OF PRODUCT IN COMMERCE 1 unit.
DISTRIBUTION NY.


PRODUCT One heart and pericardium..
CODE Donor # 12144.
RECALLING FIRM/MANUFACTURER DCI Donor Services Tissue Services Division, Nashville, TN,

REASON Human tissue was procured from donor using non-sterile instruments.
VOLUME OF PRODUCT IN COMMERCE 1 heart and pericardium.
DISTRIBUTION GA.


PRODUCT Misys Laboratory, Calculator Data processing Module for Clinical Use.

CODE Version 5.3.
RECALLING FIRM/MANUFACTURER Misys Healthcare Systems, Tucson, AZ.,.
REASON Software anomally. Graphical display omits results containing a less than (<), greater than (>) or percent (%) symbol.
VOLUME OF PRODUCT IN COMMERCE 520.
DISTRIBUTION Nationwide and Internationally.


PRODUCT a) Abbott AxSYM CA 15-3 Master Calibrator Pack, list 3B42-30; the pack contains two 4-mL bottles, with Master Calibrator 1 having 0 U/mL and Master Calibrator 2 having 60 U/mL.

b) CA 15-3 Calibrators, list 9C08-01; the pack contains six 4-mL bottles of 115D8:DF3 reactive determinants prediluted in TRIS buffer with protein stabilizers to yield the following assay values: A - 0 u/mL, B - 15 U/mL, C - 60 U/mL, D - 120 U/mL, E - 180 U/mL and F - 250 U/mL.

c) IMx CA 15-3 Reagent Pack, list 6A75-22; this reagent pack contains two 4-mL bottle of Mode 1 Calibrator along with other reagents.
CODE
a) List 3B42-50, lot 86504M300;
b) List 9C08-01, lot 88127M100;
c) List 6A75-22, lot 90843M200.
RECALLING FIRM/MANUFACTURER Abbott Laboratories HPD/ADD, Abbott Park, IL.,

REASON The CA 15-3 Calibrators may cause depressed values for the CA 15-3 High Control and for patient specimens.
VOLUME OF PRODUCT IN COMMERCE
a) 958 packs
b) 792 packs;
c) 409 packs.
DISTRIBUTION Nationwide and Internationally.


PRODUCT Tarsys 1st Generation Seating System - an optional accessory for the Powered Wheelchairs.
CODE All model numbers (excluding the 2nd generation models); Serial numbers 931 through 02E.
RECALLING FIRM/MANUFACTURER Invacare Corp.,Elyria, OH,

REASON A short circuit within the charger harness may cause heat damage to the units with potential for fire.
VOLUME OF PRODUCT IN COMMERCE 20,956.
DISTRIBUTION Nationwide and Internationally.


PRODUCT LTX Endosseous Implant 6.0 mm x 11.5 mm and also LTX Endosseous Implant 5.0 mm X 15 mm, Sterile.
CODE For LTX 611 lot number 150102P for LTX 515 lot number 150100P.
RECALLING FIRM/MANUFACTURER Implant Innovations, Inc., Palm Beach Gardens, FL,

REASON Sterile Endosseous implants may be packaged in mislabeled packaging with the incorrect size.
VOLUME OF PRODUCT IN COMMERCE 68.
DISTRIBUTION Brazil, Korea, Taiwan and Chile.


PRODUCT Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch/260 cm lengths. Packaged in a sterile pouch and a three pack shelf box.
CODE Pouch codes for the 180 cm length guidewires are: Catalog No. 46-591, UPN M001465910 Lot Number Use Before Date 4959940 2005-08 4959941 4969651 4969654 4969655 4969656.
The pouch codes for the 260 cm length guidewires are: Catalog No. 46-5912, UPN M001465920 Lot Number Use Before Date 4959945 2005-08 4959946 4959944 4959943.
RECALLING FIRM/MANUFACTURER Symbiosis, Corp., Miami, FL,

REASON The 180 cm guidewire is mislabeled as 260 cm. The 260 cm guidewire is mislabeled as 180 cm.
VOLUME OF PRODUCT IN COMMERCE 286 3-pack boxes.
DISTRIBUTION Nationwide.


PRODUCT X-ray, computed Tomography, Model TSX101A.
CODE None.
RECALLING FIRM/MANUFACTURER Toshiba American Med Systems, Inc., Tustin, CA,

REASON Misassembly can cause fire.
VOLUME OF PRODUCT IN COMMERCE 68
DISTRIBUTION Nationwide.

 

PRODUCT LH 700 Series Hematology Analyzers. Part numbers 66056032, 6605633, 6605645.
CODE All instruments with version 2A or higher.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA,

REASON Incorrect Hemoglobin result can be reported at software version 2A and higher.
VOLUME OF PRODUCT IN COMMERCE 234.
DISTRIBUTION Nationwide and Canada.

 

PRODUCT a) Ethanol Standard, 1.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case

b) Ethanol Standard, 0.5mg Ethanol in 1 mL. Product size configuration: 1 mL glass ampule shipped 10 ampules per case.

c) Papanicolaou Stain EA-50. Product size configurations: 1L, 4L, and 10L.

CODE
a) Item # 68996/95 Lot #1295; Exp. Date April 30,2004;
b) Item #68988/95; Lot #2330; Exp. Date May 31, 2005;
c) Item Nos. 7062X/75, 7062X/85, and 7062X/86. Lot #2255
Exp. Date September 30, 2004;
RECALLING FIRM/MANUFACTURER EMD Chemicals, Inc., Gibbstown, NJ,

REASON
a) The Ethanol Standard is OOS on the high end. The results were 1.58 mg/mL while the specification is 1.477-1.538 mg/mL;
b) The Ethanol Standard is OOS on the low end. The results were 0.44 mg/mL while the specification is 0.48-0.52 mg/mL;
c) Difficulty in reading slides due to the stain is much greener than normal.
VOLUME OF PRODUCT IN COMMERCE
a) 279 cases of 10 ampules;
b) 139 cases of 10 ampules;
c) 232 bottles.
DISTRIBUTION Nationwide.


PRODUCT
a) Access 2 Immunoassay System.

b) Access 2 Immunoassay side of Lxi 725.
CODE All fielded instruments.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Inc., Brea, CA,

REASON False results from secondary pour off tubes.
VOLUME OF PRODUCT IN COMMERCE a) 718; b) 10.
DISTRIBUTION Nationwide and Canada.


PRODUCT
a) Cidex Solution Test Strips Browne GA Indicators for Cidex Solution Test Strips.
b) Cidex Plus Solution Test Strips.
CODE
a) Cidex Activated, Product Code 2920 lots: 7840 7739 8064 8503 8422 8661 8771 8923 9188 9313 9414 Cidex Plus,Product Code 2924, lots: 8423 8560 9229 Cidex Plus, Product code 2926, lots: 8312 8658 9120 Cidex Activated, Product code 2927, lots: 7783 8160 8182 8604 8790 9317
9404;
b) Cidex Activated, Product Code 2920 lots: 7840 7739 8064 8503 8422 8661 8771 8923 9188 9313 9414 Cidex Plus, Product Code 2924, lots: 8423 8560 9229 Cidex Plus, Product code 2926, lots: 8312 8658 9120 Cidex Activated, Product code 2927, lots: 7783 8160 8182 8604 8790 9317
9404.
RECALLING FIRM/MANUFACTURER Advanced Sterilization Products, Irvine, CA,

REASON Test strips which are used for QC of sterilant solution fail due to ingress of moisture.
VOLUME OF PRODUCT IN COMMERCE 33,039 cases.
DISTRIBUTION Nationwide and Internationally.

 

WEEK ENDING APRIL 19

 

PRODUCT Disetronic D-TRON Insulin Infusion Pump, Models 8100001 D-TRON (blue) and 8100005 D-TRON (anthracite)

CODE All Serial numbers.
RECALLING FIRM/MANUFACTURER Recalling Firm: Disetronic Medical Systems, Inc. St. Paul, MN,

Manufacturer: Disetronic Medical Systems AG Burgdorf, Switzerland. Firm initiated recall is ongoing.
REASON Some pumps started programming a bolus that was not initiated by the pump user, and the delivery of an unintended bolus was made unless interrupted by the device user.
VOLUME OF PRODUCT IN COMMERCE 3357 insulin infusion pumps.
DISTRIBUTION Nationwide.


PRODUCT Homepump Eclipse Infusion Pump, Disposable Elastomeric Infusion System (100 ml x 50 ml/hr) Model E100500,
Part No. 5001065.

CODE Lot 262074.
RECALLING FIRM/MANUFACTURER I-Flow Corporation, Lake Forest, CA.,

REASON Product infuses too fast at rate of 30 minutes instead of 2 hours. Component mix-up.
VOLUME OF PRODUCT IN COMMERCE 2,832 units.
DISTRIBUTION CA, OH, WA,TX,UT, SC, MI, IL.


PRODUCT HeartMate Stroke Volume Limiter (SVL) Catalog # 1295.
CODE All Codes.
RECALLING FIRM/MANUFACTURER Thoratec Corp., Pleasanton, CA.,

REASON Driveline tubing connections on the SVL if under STRESS condition may snap off, VAD support is compromised, a serious injury or death can occur.
VOLUME OF PRODUCT IN COMMERCE  203.
DISTRIBUTION Nationwide and Internationally.


PRODUCT a) AxSYM Tricyclic Antidepressants Reagent.
b) Adx Tricyclic Antidepressants Reagent.
c) TDx/TDxFlx Tricyclic Antidepressant Reagent.
 CODE
a) List No. 3B34-20;
b) List No. 9681-55;
c) List No. 9681-60.
RECALLING FIRM/MANUFACTURER Abbott Health Products, Inc., Barceloneta, PR,

REASON Unexpected false positive TCA results.
VOLUME OF PRODUCT IN COMMERCE 7,049 units.
DISTRIBUTION Nationwide, and Internationally.


PRODUCT a) Tachos DR-Implantable Cardioverter Defibrillator.
b) Deikos A+ Implantable Cardioverter Defibrillator.
c) Tachos DR - Atrial TX Implantable Cardioverter
Defibrillator.

CODE a) Model No. 355 572 Serial Nos. 78011361, 78011362, 78011364, 78011365, 78011376, 78011378-78011385, 78011389-78011414, 78011416-78011424, 78011426-78011430, 78011432-78011464, 78011466-78011491, 78011493-78011499, 78011600-78011617, 78011619, 78011621-78011639,
78011641, 78011643, 78011647-78011654, 78011656-78011660, 78011684-78011686, 78011689, 78011691, 78011692, 78011699-78011701,
78011704-78011708, 78011713, 78011720-78011723, 78011730-78011743, 78011745-78011758, 78011764-78011768, 78011779;
b) Model No. 334 341 Serial Nos. 78062821, 78062822, 78062831, 78062838, 78062839, 78062901, 78062957;
c) Model No. 122 499 Serial Nos. 78010961, 78012035, 78012076, 78012077, 78012083, 78012090-78012092, 78012103-78012105, 78012109-78012111, 78012117-78012120, 78012122-78012125, 78012127, 78012132, 78012163, 78012197, 78012236, 78012292, 78012296, 78012298-78012302, 78012352, 78012354, 78012355, 78012366, 78012369, 78012374, 78012386, 78012413, 78012415, 78012564, 78012652.
RECALLING FIRM/MANUFACTURER Biotronik, Inc., Lake Oswego, OR,

REASON Potential for battery to delivery less than full amount of energy.
VOLUME OF PRODUCT IN COMMERCE
a) 240 devices;
b) 7 devices;
c) 49 devices.
DISTRIBUTION Nationwide.

PRODUCT Glitter Eyes (tefilcon), daily wear soft (hydrophilic) contact lenses packed as single units or kits in multiple glass vials.

CODE Green, PID Lot#NA, Button Lot#22940-32,
Blue, PID Lot#40523337, Button Lot#22940-32,
Bronze, PID Lot#40538359, Button Lot#22940-32,
Violet, PID Lot#40522198, Button Lot #22940-32,
Green, PID Lot#40581596, Button Lot#22985-95,
Blue PID Lot 40550786, Button Lot#22620-19,
Blue PID Lot#40505677, Button Lot#22620-20,
Bronze PID Lot#40540880, Button Lot#22620-19,
Violet, PID Lot#40543810, Button Lot#22620-19.
RECALLING FIRM/MANUFACTURER Ciba Vision Corporation, Duluth, GA,

REASON The lens may partially 'delaminate' in the area of one of the encapsulated cosmetic prints.
VOLUME OF PRODUCT IN COMMERCE 29,821 units.
DISTRIBUTION Nationwide, Canada, and Puerto Rico.


PRODUCT ICON DS hCG, an in-vitro diagnostic. Part number 44025.

CODE Lot numbers hCG010401, hCG010704, hCG010902.
RECALLING FIRM/MANUFACTURER Beckman Coulter, Brea, CA,
REASON Failure to meet sensitivity claims at end of shelf life. Potential for false negative reports.
VOLUME OF PRODUCT IN COMMERCE 12,804.
DISTRIBUTION Nationwide and Canada.