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U.S. Department of Health and Human Services

Safety

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Sepacell - Pre-storage Leukocyte Reduction Set for Red Cells

Voluntary recall. Occasional leaks during the process of leukoreduction of units of Red Blood Cells intended for transfusion. FDA considers the risk of bacteremia from Red Blood Cell units using Pre-storage Leukocyte Reduction Set for Red Cells filters (Sepacell) to be very low.

[September 22, 2000 - Letter - FDA]
[September 19, 2000 - Letter - Baxter Healthcare Corp]