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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of Baxter ALYX Red Kit Disposables-Baxter Healthcare Corp

DATE RECALL INITIATED:

October 28, 2005

PRODUCT / LOT NUMBER:

Baxter ALYX Red Kit Disposables (Designed for the ALYX Component Collection System)

4R5701All lot numbers starting with H04J, H04K, H04L, H05A, H05B, H05C, H05D, H05E, H05F, H05G, and H05H (except those suffixed with “A”)
4R5701H05I02028 (but NOT H05I02028A)
4R5701H05I13041 (but NOT H05I13041A)
4R5701H05I19071 (but NOT H05I19071A)
Unaffected lots include any lot numbers labeled with an “A” suffix.MANUFACTURER:

Baxter Healthcare Corporation
Round Lake, Illinois

REASON:

Baxter Healthcare Corporation has received reports from users of the ALYX Component Collection System of leaks from the cassette of the disposable kit. Such leaks have a potential to create a breach of the sterile pathway within the cassette with a theoretical risk of bacteremia to donors if there has been blood returned to the donor before the leak was detected. To date Baxter has received no complaints of bacteremia associated with this issue. 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