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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Amicus Apheresis Kits-Baxter Healthcare Corporation

DATE RECALL INITIATED:

 

January 31, 2005

 

PRODUCT / LOT NUMBER / EXPIRATION DATE:

 

Product Code 4R2310

 

N04D22010 April 2005
N04F14012 June 2005
N04F15019 June 2005
N04F16017 June 2005
N04F21017 June 2005
N04F22015 June 2005
N04F24011 June 2005
N04F28012 June 2005
N04F29010 June 2005
N04F30018 June 2005
N04G22013 July 2005
N04G23011 July 2005
N04G02023 July 2005
N04G12014 July 2005
N04G13012 July 2005
N04G14010 July 2005
N04G15017 July 2005
N04G16015 July 2005
N04G30016 July 2005
N04H16013 Aug 2005
N04H10016 Aug 2005

 

PRODUCT / LOT NUMBER / EXPIRATION DATE:

 

Product Code 4R2312

 

N04E27024 May 2005
N04F18013 June 2005
N04F25018 June 2005
N04G01017 July 2005
N04G20017
July 2005
N04G20025 July 2005
N04G06016 July 2005
N04G07014
July 2005
N04G08012 July 2005
N04G09010 July 2005
N04G10018 July 2005
N04G19019
July 2005


MANUFACTURER:

 

Baxter Healthcare Corporation
Deerfield, IL

 

REASON:

 

Baxter is performing a voluntary product recall on Amicus Apheresis Kits for the above listed lots. Pinhole leaks were observed at the two-omega end of the umbilicus (multilumen tubing), causing a blood leak. If an umbilicus leak occurs during a procedure, the Amicus instrument will detect the leak, halt the procedure, and isolate the donor. If an umbilicus leak is detected, either during the procedure or after the procedure is completed, the product should be immediately discarded. Consignees have been asked to contact the manufacturer to arrange for product return.

 

 

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