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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Additional Lot of Leukocyte Reduction BPF4 High Efficiency Filter-Pall Medical Corp

DATE RECALL INITIATED:

February 23, 2005

LOT NUMBER:

Product Code 430-50

0450737

MANUFACTURER:

Pall Medical Corporation
2200 Northern Blvd
East Hills, NY 11548

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

 

Contact FDA

(800) 835-4709
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448