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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Platelet Sampling Device-Charter Medical Ltd

DATE RECALL INITIATED:

March 30, 2005

PRODUCT / PRODUCT NUMBERS

Platelet Sampling Device

Product Numbers: 03-220-AC, 03-220-BC, 03-220-LKY, 03-220-TMR

MANUFACTURER:

Charter Medical, Ltd
Winston-Salem, NC

REASON:

Charter Medical, Ltd. has initiated a voluntary recall of ethylene oxide (EtO) sterilized Class II devices manufactured since January 1, 2001. The sterility of these devices may be compromised due to an inadequate validation of the sterilization cycle. Consignees have been asked to return any affected product to the manufacturer.

Additional products recalled 1/24/2005

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448