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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Product Detail

Product Description Red Blood Cells Leukocytes Reduced
Recall Number B-2253-13
Classification Class III
Code Info 02GJ05218;02GJ05251;02E32153;02GJ05203;02K09857; 02GJ05235;02K09839;02GJ05204;02GJ05207;02GJ05201; 02FE46227;02K09807;02GJ05241;02GJ05216;02FZ28706; 02GJ05202;02FE46218;02FE46208;02K09834;02GJ05242; 02GJ05244;02FE46253;02FE46223;02K09806;02K09841; 02K09836;02FE46255;02FE46249;02FE46222;02GJ05211; 02GJ05248;02K09819;02FE46246;02FE46252;02FZ28710; 02GJ05205;02FE46229;02FE46220;02FE46221;02FE46232; 02FE46213;02FE46236;02FE46216;02K09884;02K09818; 02K09810;02K09815;02K09870;02GJ05181;02FE46237; 02K09845;02K09844;02K09887;02GJ05196;02GJ05186; 02GJ05179;02FE46174;02GJ05221;02GJ05236;02GJ05214; 02K09879;02FE46193;02K09816;02K09792;02GJ05213; 02GJ05185;02K09804;02K09862;02K09871;02FZ28708; 02FZ28713;02GJ05280;02GJ05188;02GJ05194;02GJ05233; 02GJ05231;02K09787;02GJ05229;02GJ05224;05GJ05212; 02GJ05228;02GJ05215;02GJ05226;02GJ05232;02K09786; 02K09785;02K09780;02K09803;02GJ05239;02K09782; 02GJ05240;02K09783;02K09808;02K09797;02FE46257; 02FE46241;02FE46256;02FE46250;02FE46239;02FE46243; 02FE46238;02FZ28709;02FZ28704;02FZ28712;02GJ05190; 02GJ05206;02GJ05189;02GJ05184;02FE46198;02FE46189; 02FE46195;02FE46190;02FE46196;02FE46206;02FE46201; 02FE46187;02FE46192;02FE46197;02FE46204;02FE46224; 02FE46210;02FE46211;02FE46254;02FE46217;02FE46233; 02FE46248;02K09880;02K09881;02K09883;02K09885; 02K09856;02K09852;02K09863;02K09875;02FE46180; 02K09811;02K09795;02K09828;02K09835;02K09843; 02K09850;02K09793;02K09798;02K09809;02K09860; 02K09865;02K09858;02K09876;02FE46181;02FE46172; 02FE46183;02E32152;02FE46168;02FE46178;02K09822; 02K08848;02K09833;02K09825
Product Distributed Qty 158 Units
Reason For Recall Blood products, in which viral testing/testing performed, interpreted, or documented incorrectly, were distributed.

Event Detail

Event Id 46550
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Wichita
State KS
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-11-21
Initial Firm Notification of Consignee or Public FAX
Distribution Pattern Kansas; Oklahoma; Texas
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