• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

  • Print
  • Share
  • E-mail

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

DATE NOTIFICATION INITIATED:

January 25, 2006

PRODUCT / LOT NUMBER:

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)

MANUFACTURER:

Baxter Healthcare Corporation
Largo, Florida

REASON:

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
(301) 827-1800
Consumer Affairs Branch (CBER)

Division of Communication and Consumer Affairs

Office of Communication, Outreach and Development

Food and Drug Administration

1401 Rockville Pike

Suite 200N/HFM-47

Rockville, MD 20852-1448