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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Medical Devices - Biomet Biologics, Inc

DATE RECALL INITIATED:

March 5, 2007

CATALOG NUMBER / DEVICE BRAND NAME:

 

800-0503A           GPS Mini Platelet Concentrate Separation Kit with 30mL ACD-A
800-0504A           GPS Mini Platelet Concentrate Separation Kit with 50ML ACD-A
800-0515             Plasmax Plus Plasma Concentrator with GPS II and 50ML ACD-A
800-1001A           GPS II Platelet Concentrate Separation Kit 50mL ACD-A
800-1002A           GPS II Platelet Concentrate Separation Kit 50mL ACD-A Double
800-0501             Plasma Plasma Concentrator with GPS Mini and 50mL ACD-A

 

International Distribution Only:

 

800-0621A GPS II Double Unit with Syringes 30mL ACD-A
800-0650 Recover Mini Platelet Separation Kit 30mL ACD-A
800-0721A GPS II Single Unit with Syringes 30mL ACD-A
800-0921 GPS II Single Unit with Syringes

MANUFACTURER:

Biomet Biologics, Inc.
Warsaw, Indiana

REASON:

Biomet Biologics, Inc. has received a Medical Device Recall initiated by the original equipment manufacturer of 30mL sterile syringes, Becton and Dickinson ("BD"). This syringe is included in a certain number of Biomet Biologic's GPS, GPS II, Plasmax, and Recover GPS II kits for use in the processing of autologous blood. BD's recall states that this action was initiated due to the unit label on a limited number of syringes was incorrect, citing 20mL size. All other levels of labeling and the product itself are correct, identifying the product as 30mL. This incorrect 20mL unit package has not been fully qualified for the 30mL size and it could potentially result in issues with package integrity and sterility maintenance.

 

Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002