• 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 of Baxter Amicus Separator-Baxter Healthcare Corp

DATE RECALL INITIATED:

March 16, 2005

PRODUCT / LOT NUMBER:

AMICUS SEPARATOR

Product Codes 4R4580 and 4R4580R
All Serial Numbers

MANUFACTURER:

Baxter Healthcare Corporation
Deerfield, Illinois

REASON:

Baxter has redesigned the AMICUS SEPARATOR Instrument centrifuge window to withstand ammonia cleaning; however it is Baxter's recommendation that ammonia and ammonia based cleaners NOT be used to clean any part of the AMICUS SEPARATOR Instrument. Instead, a mild soap/detergent is recommended. Baxter will replace the AMICUS SEPARATOR Instrument centrifuge window on all AMICUS SEPARATOR Instruments.

 

 

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