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DATE RECALL INITIATED: November 18, 2005 PRODUCT / LOT NUMBERS / EXPIRATION DATE: MacoPharma Leucolab LCG2 Leukoreduction System for Red Blood Cells KSV0004XD Lot Numbers: 232305F14,   232305F20 Expiration Date: June, 2008 MANUFACTURER: MacoProductions S.A.S. France DISTRIBUTOR: UnitedPharma Duluth, Georgia REASON: Two lots of MacoPharma’s Leucolab LCG2 Leukoreduction System for Red Blood Cells are recalled due to potential failure to meet leukoreduction requirements. These two lots have exhibited isolated examples of failure to achieve leukoreduction of < 5 x 106 when red blood cells are processed according to the manufacturer’s instructions for use. 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 November 22, 2005

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