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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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12/17/2004 Recall Notice

 

Recall of Leukocyte Reduction BPF4 High Efficiency Filter

 

 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
 

 

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