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DATE RECALL INITIATED:
March 17, 2003
LOT NUMBERS / EXPIRATION DATES:
M03A09014 9/30/2004
M03A09014A 9/30/2004
MANUFACTURER:
Baxter Healthcare Corp / Fenwal Division
Maricao, Puerto Rico
REASON:
Baxter Healthcare has become aware of leaks involving the PL 732 platelet container during component preparation The reported leaks occurred during expression of plasma from the platelet container. Blood products successfully processed in containers that did not split are not affected.
Consignees have been asked to contact the manufacturer to arrange for product return.
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.
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