Recall of Amicus Separator Operating with Version 2.50 Software

DATE RECALL INITIATED:

May 31, 2001

PRODUCT:

Amicus Separator
Instruments operating with Version 2.50 Software are subject to the recall

MANUFACTURER:

Baxter Healthcare Corporation
Round Lake, Illinois

REASON:

Baxter Healthcare Corporation is recalling Amicus Separators operating with version 2.50 software after discovering that the device may return an inappropriate volume of plasma to a donor during an apheresis procedure. This occurrence has been observed during single needle procedures using Amicusâ Separators operating with Version 2.50 software in which the ‘inlet line occlusion auto restart feature’ (auto restart) is turned “ON”. Individuals may experience clinical symptoms of citrate related toxicity and/or fluid overload as a result of the problem.

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