• 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
(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