Baxter Healthcare Corporation Class II

Company: Baxter Healthcare Corporation
Date of Enforcement Report: 9/5/01
Class: II

RECALL NUMBER, PRODUCT AND CODE:
B-1332-1, Amicus Separator Apheresis Instrument with software version 2.50

REASON:
Blood collection device may return an inappropriate volume of plasma to a donor during an apheresis procedure.

MANUFACTURER:
Baxter Healthcare Corporation, Largo, FL

RECALLED BY:
Baxter Healthcare Corp., Round Lake, FL, by letters and facsimiles dated May 31, 2001

FIRM INITIATED RECALL:
Ongoing

DISTRIBUTION:
Nationwide and internationally

QUANTITY:
184 Units

About the author

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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