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DATE RECALL INITIATED: December 17, 2004 LOT NUMBERS: Product Code 430-41 0450481 0450520 0450560 0450583 0450613 0450630 0450650 0450672 0450673 0450674 0450684 0450685 0450690 0450707 0450708 0450712 0490006 Product Code 430-50 0450574 0450626 0450661 0450665 0450668 0450710 0450714 Product Code BPFB 0450615 MANUFACTURER: Pall Medical Corporation 2200 Northern Blvd East Hills, NY 11548 REASON: Pall Medical has received reports of hemolysis in the attached segment tubing and the storage bags observed at varying times following filtration using this product. An investigation is ongoing to determine the root cause of the hemolysis. Consignees have been asked to discontinue use of the lot numbers and to contact the manufacturer via Recall Response Forms. 2/23/2005 Recall Notification 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 February 25, 2005

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