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September 20, 2000

Sepacell® Pre-storage Leukocyte Reduction Set for Red Cells Recalled

FDA Update Statement Sep 22 HERE

Deerfield, IL (SafetyAlerts) - Baxter Healthcare Corporation has announed a recall of its Sepacell® Pre-storage Leukocyte Reduction Set for Red Cells after the firm became aware of reports that the product was occasionally leaking during the process of leukoreduction of units of Red Blood Cells intended for transfusion. A leak during the leukoreduction process may result in a unit of Red Blood Cells made available for transfusion that lacks assurance of freedom from bacterial contamination. Based on currently available, preliminary information, CBER is not aware of any reports of bacterial contamination in recipients of Red Blood Cells leukoreduced with the recalled filters. The recall notification instructs establishments that currently have in inventory units of Red Blood Cells leukoreduced with the recalled filters to exercise judgment in determining whether use of the Red Blood Cells is appropriate, and to thoroughly inspect the units of Red Blood Cells for evidence of bacterial contamination. CBER will continue to monitor the recall.

Product code 4C2300

All lot numbers beginning with A00E, A00F, A00G, and A00H

FDA Update Statement Sep 22 HERE

Baxter Healthcare Corporation
Fenwal Division
Deerfield, IL.

Selected Recent Recalls

Health Professional:

Did you know?
During 2000 there were over
1050 products recalled in the United
States for safety reasons!

How many did you hear about?

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