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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
(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