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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. The information in this listing reflects CBER's best efforts to communicate information that has been reported to FDA. Its accuracy and comprehensiveness cannot be guaranteed.

Updated May 4, 2005

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