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Cryolife Inc: CryoValve, Pulmonary Valve & Conduit

This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.

FDAApr 19, 2004MO, TX• Cryolife Inc

Cryolife Inc: CryoValve, Aortic Valve & Conduit SG

This recall was initiated as part of the firm's retrospection review of tissues associated with complaints of alleged recipient infection.

FDAApr 19, 2004MO, TX• Cryolife Inc

Datex-Ohmeda Inc One Ohmeda: Datex-Ohmeda Aestiva/5 Active Gas Scavenging System used ...

Increased circuit pressure as a result of a misassembled Aestiva/5 Active Gas Scavenging System.

FDAApr 16, 2004Nationwide• Datex-Ohmeda Inc One Ohmeda

Braun, B Medical Inc: 18G Catheter is a component in various kits.

Catheter separated from the hub.

FDAApr 16, 2004CA, CO, FL +26 more• Braun, B Medical Inc

Philips Medical Systems Sales & Service Region No. America: Xcelera System, image processing, radiological.

Potential for the image data to be erased from the long term archive.

FDAApr 15, 2004Nationwide• Philips Medical Systems Sales & Service Region No. America

R & D Systems, Inc: ABX Diagnostics Minotrol 16 Hematology Controls, Normal a...

Clots in hematology controls resulted in low red blood cell counts when used in blood analyzers because control values were outside the expected range due to the clotting which took place after manufacturing.

FDAApr 15, 2004CA• R & D Systems, Inc

Professional Hedge Trimmers (Shindaiwa) – Operation Hazard (2004)

The 30-inch and 40-inch hedge trimmers have red engine covers, a red fuel cap and a label on the recoil starter that reads "Professional Shindaiwa." The recall includes all double-sided professional hedge trimmer models DH 231 and HT 231 with serial numbers up to 110000. The serial numbers are printed on a nameplate on the engine cover.

CPSCApr 15, 2004Nationwide• Shindaiwa Inc., of Tualatin, Ore.

NxStage Medical, Inc.: NxStage Cartridge Express. A disposable extracorporeal bl...

Pinhole leaks on the replacement (RF) side FMP bag in certain lots of its disposable cartridge balance chambers resulting in loss of dialysate or ultrafiltrate

FDAApr 14, 2004CA, IL, IN +6 more• NxStage Medical, Inc.

Batman Batmobile Toy (Mattel) – Safety Defect (2004)

Laceration Risk

The recalled "BATMAN™ BATMOBILE™" toy car is a 20-inch blue and gray plastic vehicle with a detachable motorcycle. Model number B4944 is written on the bottom of the toy vehicle.

CPSCApr 14, 2004Nationwide• Mattel Inc., of El Segundo, Calif.

Tonka Ride-On Toys (Tek Nek) – Child Safety (2004)

The ride-on toys were sold under five model names including Butterfly Girl, Fire Rescue, Mermaid, Police Car, and Tonka Construction Crew. The toys can be used as a ride-on or push walker toy, with a handle on the back of the seat rest. These toys were sold for children ages 1 to 3 years old. On the dash of the ride-on toys are buttons which produce sounds when activated. The recalled Ride-on vehicles have a date code from 20021127 to 20030319. The date code is located in the battery compartment located on the top panel next to the steering wheel.

CPSCApr 14, 2004Nationwide• Tek Nek Toys International, L.P., of Grapevine, Texas

Baxter Healthcare Corp. Rt.: Colleague 3 Triple Channel Volumetric Infusion Pumps, pro...

Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

FDAApr 13, 2004Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Colleague 3 CX Triple Channel Volumetric Infusion Pumps, ...

Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

FDAApr 13, 2004Nationwide• Baxter Healthcare Corp. Rt.

Baxter Healthcare Corp. Rt.: Colleague Single Channel Volumetric Infusion Pumps, produ...

Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

FDAApr 13, 2004Nationwide• Baxter Healthcare Corp. Rt.

Bunk Beds (Ethan Allen) – Guardrail Safety Concern (2004)

The top bunk guardrails on Ethan Allen Ryan and P.J. Bunk Beds have item numbers 35-5659-4, 36-5659-3 or 36-5659-4. Item numbers can be found on the inside of the bottom bunk headboard or footboard. The "j" hooks were incorporated into the guardrails of bunk beds as a locking/unlocking device. When unlocked and out of position, the guardrail can be removed for easy access to change bed linen.

CPSCApr 13, 2004Nationwide

Radio-Control Toy Trucks (Nikko America) – Performance Issue (2004)

The recalled toy trucks were manufactured from April 2003 through January 2004. The trucks are 1/10 scale models (approximately 18 inches in length) of the Chevy Avalanche (model 100021A), the Jeep Wrangler Rubicon (model 100022A and 100022B), the Hummer Wagon (model 100023A and 100023B) and the Ford F150 (model 100024A and 100024B). Model numbers can be found on the body of the truck, along with the vehicle make and model names.

CPSCApr 13, 2004Nationwide• Nikko America Inc., of Plano, Texas

Busse Hospital Disposables: Suction Instrument with Tubing, Catalog No. 302. Instrume...

Firm received complaints of "melting" at tubing connection. The connecting part of the Yankauer becomes soft after extended direct contact with the PVC tubing. This results in a slower rate of suction.

FDAApr 13, 2004Nationwide• Busse Hospital Disposables

Baxter Healthcare Corp. Rt.: Colleague CX Single Channel Volumetric Infusion Pumps, pr...

Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

FDAApr 13, 2004Nationwide• Baxter Healthcare Corp. Rt.

Cryolife Inc: CryoValve, Conduit and Pulmonary Valve and Conduit

CryoLife received information regarding a positive culture for Group A Streptococcus infection in a recipient of tissue procured from the attached donor.

FDAApr 12, 2004NM• Cryolife Inc

Advanced Sterilization Products: CIDEX OPA Solution, ortho-Phthalaldehyde Solution

Anaphylactic-like reactions were reported following repeated cystoscopy for bladder cancer patients where the scope had been reprocessed in CIDEX OPA Solution.

FDAApr 12, 2004Nationwide• Advanced Sterilization Products

Diasorin Inc.: Version 12 software program written for the Bio-Tek ELx80...

The software program written for use in the automated microtiter plate reader (Bio-Tek ELx800) for use with the Pro-Trac II Tacrolimus ELISA kit was found to be faulty. Assay software program did not include the Calibrator Zero OD specification (STDO>=1.500) as specified in the product insert.

FDAApr 12, 2004CA, FL, KY +2 more• Diasorin Inc.

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