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
