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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Event Detail

Event ID 52246
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Omaha
State NE
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2009-02-27
Initial Firm Notification of
Consignee or Public
Distribution Pattern NE; CO; PA; NJ; AL; OK

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells (Apheresis) Leukocytes Reduced 009FC30192; 009GP38408; 009FC30192; 009GP38408; 009FC30202; 009GP38509; 009FC30205; 009GP38509; 009FC30205; 009GP38510; 009FC30548; 009GP38513; 009FC30548; 009GP38513; 009FC30559; 009GP38514; 009FC30559; 009GP38514; 009FC30562; 009GP38529; 009FC30562; 009GP38536; 009FC30567;009GP38536; 009FC30567; 009GP38537; 009FC30585; 009GP38537; 009FC30585; 009GP38713; 009FC30608; 009GP38713; 009FC30608; 009GP38722; 009FC30611; 009GP38722; 009FC30613; 009GP38765; 009FC30614; 009GP38765; 009FC30617; 009GP38778; 009FC30617; 009GP38778; 009FC30686; 009GP38790; 009FC30686; 009GP38790; 009FC30702; 009GP38791; 009FC30702; 009GP38791; 009FC30704; 009GP38845; 009FC30704; 009GP38848; 009FC30707; 009GP38848; 009FC30707; 009GP38858; 009GP38367; 009GP38858; 009GP38367; 009KE16379; 009GP38376; 009GP38376; 009GP38384; 009GP38384; 009GP38394; 009GP38394 Class II Blood products, labeled 'leukocytes reduced' which did not meet the QC requirements for leukoreduced products, were distributed. 70 Units B-1320-13