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
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
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