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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. 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 February 18, 2005

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