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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of CPDA-1 Quadruple Blood-Pack Unit, Baxter Blood-Pack Unit (BPU) with Samplink Access Device-Baxter Healthcare Corp

DATE RECALL INITIATED:

March 16, 2005

PRODUCT / SERIAL NUMBER / EXPIRATION DATE:

Blood-Pack Unit with Samplink Access Device
Product Code 4R1247MC

Serial Number Expiration Date

M02I26046 3/31/2005
M02I26046A 3/31/2005
M02J10064 4/30/2005
M02J10064A 4/30/2005
M02K18032 5/31/2005
M02K30029 5/31/2005
M03A31067 7/31/2005
M03B14038 8/31/2005
M03B14038A 8/31/2005
M03B28053 8/31/2005
M03C21056 9/30/2005
M03E28056 11/30/2005
M03K06051 5/31/2006
M04A17032 7/31/2006
M04C26039 9/30/2006
M04E07034 11/30/2006

 

MANUFACTURER:

Baxter Healthcare Corporation
Round Lake, Illinois

REASON:

Baxter has determined that expired Samplink access devices were included in cases of Blood-Pack Unit, Product Code Number 4R1247MC (the Blood-Pack Units were not expired). Baxter will no longer supply the Samplink access device along with the Blood-Pack Units product in the same finished goods carton. The Blood-Pack Units product and the Samplink will be shipped in separate containers. 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