DATE RECALL INITIATED:
PRODUCT / PRODUCT NUMBERS
Platelet Sampling Device
Product Numbers: 03-220-AC, 03-220-BC, 03-220-LKY, 03-220-TMR
Charter Medical, Ltd
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.