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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 The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated April 13, 2005

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