May

2001

Baxter Healthcare Corporation

Recall of Amicus Separator Operating with Version 2.50 Software

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 Amicus 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.

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

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Baxter Healthcare Corporation

Amy Sellers

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