DATE RECALL INITIATED:
LOT NUMBERS:
Product Code 430-41
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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
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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.
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