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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Event Detail

Event ID 57786
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross
City Salt Lake City
State UT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2010-11-09
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Utah, Nevada, Washington DC, California, North Carolina and Pennsylvania

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Blood and Blood Products for Reprocessing 020LE34036, 020LE34040, 020LE34041, 020LE34043, 020LE34044, 020LE34045, 020LE34046, 020LE34048, 020LE34051, 020LE34053, 020LE34054, 020LE34055, 020LE34056, 020LE34059, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34064, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34073, 020LE34074, 020LE34075, 020LE34076, 020LE34077, 020LE34078, 020LE34079, 020LE34080, 020LE34081. Class III Blood products, possibly contaminated with air, were distributed. 36 components B-1019-13
Red Blood Cells Leukocytes Reduced 020LE34037 , 020LE34039 , 020LE34041 , 020LE34042 , 020LE34046, 020LE34047, 020LE34048, 020LE34049, 020LE34050, 020LE34051, 020LE34052, 020LE34054, 020LE34056, 020LE34057, 020LE34060, 020LE34061, 020LE34062, 020LE34063, 020LE34065, 020LE34066, 020LE34067, 020LE34068, 020LE34069, 020LE34070, 020LE34071, 020LE34072, 020LE34074, 020LE34076, 020LE34077, 020LE34078, Class II Blood products, possibly contaminated with air, were distributed. 30 components B-1020-13
Plasma Frozen Within 24 Hours After Phlebotomy (FP24) 020LE34038, 020LE34049, 020LE34052, 020LE34057, 020LE34058. Class II Blood products, possibly contaminated with air, were distributed. 5 components B-1021-13
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