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Device Correction: Operator’s Manual for Baxter Fenwal Amicus Separator-Baxter Healthcare Corp


January 25, 2006


Operator’s Manual for Baxter Fenwal Amicus Separator Apheresis Device
Product Code 4R2332 (All Serial Numbers)

Amicus Separators Apheresis Devices
Product Codes 4R4580 and 4R4580R (All Serial Numbers)


Baxter Healthcare Corporation
Largo, Florida


Baxter has become aware of the remote possibility for hemolyzed blood to be returned to the donor after a specific maintenance procedure. Chapter 6 “Maintenance” in the Amicus Operator’s Manual describes a procedure for cleaning the pump head after a blood or fluid spill. To address this issue, Baxter is updating the Amicus Operator’s Manual to remove the maintenance step instructing users to perform the lubrication of the pump head. Instead, qualified Baxter personnel will perform this task during routine servicing and/or preventative maintenance.


Contact FDA

(800) 835-4709
(240) 402-8010
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

10903 New Hampshire Avenue

Building 71 Room 3103

Silver Spring, MD 20993-0002