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U.S. Department of Health and Human Services

Enforcement Report - Week of June 5, 2013

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Product Detail

Product Description Red Blood Cells (Apheresis) Leukocytes Reduced
Recall Number B-1320-13
Classification Class II
Code Info 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
Product Distributed Qty 70 Units
Reason For Recall Blood products, labeled 'leukocytes reduced' which did not meet the QC requirements for leukoreduced products, were distributed.

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 FAX
Distribution Pattern NE; CO; PA; NJ; AL; OK