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Recall of Additional Lot of Leukocyte Reduction BPF4 |
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DATE RECALL INITIATED: February 23, 2005 LOT NUMBER: Product Code 430-50 0450737 MANUFACTURER:
Pall Medical Corporation REASON: Pall Medical has received additional reports of hemolysis in the attached segment tubing and the storage bags observed at varying times during filtration using this product. An investigation is on going to determine the root cause of the hemolysis. Consignees have been asked to discontinue use of the lot number and to contact the manufacturer via Recall Response Forms. 12/17/2004 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.
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