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U.S. Department of Health and Human Services

Vaccines, Blood & Biologics

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Recall of LCG2 Leukoreduction System for Red Blood Cells-MacoProductions S.A.S.

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.
 

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