JANUARY 2001

WEEK ENDING JANUARY 5

PRODUCT Immulite brand Total T3 Test Kit, in-vitro diagnostic device: a) Catalog #LKT31, 100 test kit;

b) Catalog #LKT35, 50 test kit.

CODE Lot #202.

MANUFACTURER Diagnostics Products Corporation, Los Angeles, California.

DISTRIBUTION Nationwide and international.

QUANTITY a) 284 kits; b) 60 kits were distributed.

REASON An additional piece of labeling, an "Important Notice" was included in the kit and it instructed the customer to use control target values that differed from the package insert instructions.

PRODUCT Scorpio TS Total Knee Tibial Tray, part of the Osteonics Scorpio Total Knee System that includes the femoral, patellar, tibial bearing insert, bone augmentation and components which are designed to be used together for total reconstructive replacement of the knee joint.Catalog #77-4003 through 77-4013.

CODE

Catalog No. Lot No.

77-4003 T00E251, T00K434

77-4005 T00E253, T00E256, T00257, T00K384

77-4007 T00E258, T00E259, T00E260,T00E262, T00K387

77-4009 T00E263, T00E264, T00E265, T00E267, T00L663

77-4011 T00E268, T00E269, T00K441, T00L664

77-4013 T00E274, T00K443, T00K444.

MANUFACTURER Howmedica Osteonics Corporation, Allendale, New Jersey.

DISTRIBUTION Nationwide.

QUANTITY 88 units were distributed.

REASON The screw hole plugs became dislodged during implantation.

WEEK ENDING JANUARY 12

PRODUCT Cryovalve Allograft, human heart valve replacement implant.

CODE Model number PV00, S/N 6790417.

MANUFACTURER Cryolife, Kennesaw, Georgia.

DISTRIBUTION Missouri.

QUANTITY 1 unit was distributed.

REASON The donor possessed adenocarcinoma of the prostate.

PRODUCT Dual Stage Venous Cannula, Model No. TF36460.

CODE Lot number 58107837.

MANUFACTURER Baxter Research Medical, Inc., Midvale, Utah.

RECALLED BY Baxter Edwards, Irvine, California

DISTRIBUTION Alabama, California, Florida, and Indiana.

QUANTITY 231 pouches.

REASON Sterility of the device has been compromised by loss of pouch integrity. An incomplete seal on the pouch was caused by lack of vents in the plastic liner, which are needed to properly vent the pouch during EtO sterilization.

SAFETY ALERTS

PRODUCT Gynecare Versapoint Bipolar Electrosurgery Electrodes and Connector Cables:

a) Resectoscope Electrode (Product Codes 1930, 1939, 1948, 1950, 1980, 1985);

b) Electrode--Spriong Tip, 5 FR (Product Codes 0471, 0472);

c) Electrode--Twizzle Tip, 5 FR (Product Codes 0470, 0467);

d) Electrode--Ball Tip, 5 FR (Product Codes 0466, 0469).

e) RN-001/004-1.

CODE All lot numbers.

MANUFACTURER Ethicon, Inc., Somerville, New Jersey.

DISTRIBUTION Nationwide.

QUANTITY 2400 electrodes and 400 hand pieces were distributed.

REASON The device may cause gas embolism events during hysteroscopic surgery.

WEEK ENDING JANUARY 26

PRODUCT:

a) Sarns Turbo 440 Oxygenator with cardiotomy venous reservoir;

b) Sarns Turbo 440 Oxygenator;

c) Sarns low prime Oxygenator;

d) Sarns low prime Oxygenator with cardiotomy venous reservoir.

CODE: a) Product No. 4943; b) Product No. 5794; c) Product No. 5796; d) Product No. 4944.

MANUFACTURER: Terumo Cardiovascular Systems Corp., Ann Arbor, MI.

DISTRIBUTION: United States, Australia, Brazil, Colombia, Germany, Hong Kong, India, Japan, Malaysia, Taiwan ROC, and VA Medical Centers in Minneapolis, MN and Madison, WI.

QUANTITY: a) 11,388; b) 43,605; c) 11,004; d) 5,190; Total: 71,187.

REASON: Venous inlet port connector may disconnect from oxygenator.

PRODUCT: CryoValve Allograft.

CODE: a) Model No. AVOO - Serial Nos. 3908577, 3965244 6246443; b) Model No. PVOO - Serial Nos. 3965252, 6246451.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: New York, NY, Rochester, MN, Pasadena, CA and Denver, CO.

QUANTITY: 5 valves.

REASON: Product does not meet current guidelines regarding serodilution of plasma.

PRODUCT: CryoValve Allograft.

CODE: a) Model No. AVOO - Serial Nos. 3741133; b) Model No. PVOO - Serial Nos. 3741125.

MANUFACTURER: Cryolife, Inc., Kennesaw, GA.

DISTRIBUTION: Dallas, TX and Pasadena, CA.

QUANTITY: 2 valves.

REASON: Donor does not meet current guidelines regarding serodilution of plasma.

PRODUCT: LTV Series Ventilator. Recall Nos. Z-154/156-1.

CODE: Model No. LTV 1000; Model No. LTV 950; Model No. LTV 900.

MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA.

DISTRIBUTION: Nationwide, Puerto Rico, Australia, Brazil, Canada, Colombia, Chile, China, England, Greece, Hong Kong, India, Israel, Japan, Malaysia, Mexico, New Zealand, Poland, Sweden, Taiwan ROC, Thailand.

QUANTITY: 2415 Units.

REASON: Failure of the LTV series ventilator software to detect a disconnect.

PRODUCT: LTV Series Ventilator.

CODE: Model No. LTV 1000; Model No. LTV 950; Model No. LTV 900.

MANUFACTURER: Pulmonetic Systems, Inc., Colton, CA.

DISTRIBUTION: Nationwide, Puerto Rico, Australia, England, Sweden, Canada, Japan, New Zealand, Switzerland, Thailand, India, Hong Kong.

QUANTITY: 1213 domestic, 1103 international.

REASON: Audible alarm disabled due to a metallic button migration.

PRODUCT: Bicor Oxygenators. a) Bicor 200 High Performance Oxygenator; b) Bicor 200 High Performance Oxygenator with integrated hard shell venous reservior.

CODE: a) Lot No. R050300; Lot No. R041700.

MANUFACTURER: LifeStream International, The Woodlands, TX.

DISTRIBUTION: AR, PA, and TX and Liechtenstein and Germany.

QUANTITY: 100 units, Lot R050300/ 28 units and Lot R041700/ 72 units.

REASON: Device arterial port became detached.

PRODUCT: ROCHE Elecsys Troponin T and T Stat.

CODE: T catalog number 2017644, T Stat catalog number 2017423. All Lot Numbers.

MANUFACTURER: Roche Diagnostics Corp., Indianapolis, IN.

DISTRIBUTION: Nationwide.

QUANTITY: 38,373 kits.

REASON: Negative bias of approximately 30% with specimens containing potassium oxalate or sodium fluoride.

PRODUCT: System 1000 Single Patient Hemodialysis Delivery System; Model SYS1000; all series 1000 systems labeled as System 1000, Altra-Touch and Althin Tina.

CODE: a) Main Power Switch issue - Serial Nos. 01001 through 08000; b) Level Adjustment System issue - Serial Nos. 01001 through 15894, 1001S through 1142S, and 50001 through 52109. c) Particle Filter issue - Serial Nos. 01001 through 12906, 1001S through 1142S, 50001 through 52109. D) Check Value issue - Serial Nos. 01001 through 14364, 1001S through 1142S, 50001 through 52109.

MANUFACTURER: Althin Medical, Inc., Miami Lakes, FL.

RECALLED BY: Baxter Healthcare Corp

DISTRIBUTION: Nationwide.

QUANTITY: 17145 units.

REASON: a) electrical arcing emanating from main power switch; b) level adjustment pump doesn't turn off when control button released; c) ultrafiltration control valves fail to close fully; d) predialyzer valve failure causes reverse ultrafiltration.

PRODUCT: Gynecare TVT Tension-Free.

CODE: Product Code: 510041; Lot Nos. PB4CPBA, PB4CPGA, PB4CQBA, PB4CQJA, PB4CQLA, PB4CQQ .

MANUFACTURER: Ethicon, Inc., Somerville, NJ.

DISTRIBUTION: Products were distrbuted to 48 states including Washington, DC.

QUANTITY: 5,000 units.

REASON: Needle Separating from the mesh.