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U.S. Department of Health and Human Services

Enforcement Report - Week of September 25, 2013

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Event Detail

Event ID 63853
Product Type Biologics
Status Terminated
Recalling Firm American Red Cross Blood Services
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-10-18
Initial Firm Notification of
Consignee or Public
FAX
Distribution Pattern MO; GA; IL; TN; TX; KY; AR; CA; France; Saipan; Guam

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Frozen 011LE69759; 011KY66463; 011KM56639; 011KY65726; 011KV59969; 011KY63082; 011KY63094; 011KV59981; 011LE71794; 011KY63689; 011KV60728; 011LE72407; 011KY64233; 011LE73137; 011KY64249; 011LE73145; 011KY64257; 011KV57065; 011KV58986; 011LQ02582; 011KV59001; 011KE96885 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 22 Units B-2317-13
Red Blood Cells Leukocytes Reduced 011KY66486; 011KY66463; 011LE71292; 011KY66745; 011LE68827; 011LE69759; 011LE70329; 011LE70832; 011LQ02672; 011KY64773; 011KY64845; 011LQ03311; 011KY64848; 011KJ37754; 011KY65293; 011KM56639; 011KY65726; 011KV56889; 011KV59977; 011LE71387; 011KY63082; 011KV59981; 011LE71394; 011KY63094; 011KV60728; 011LE71794; 011KY63689; 011KV61312; 011LE72400; 011KY63701; 011KV62180; 011LE72407; 011KY64233; 011KY62963; 011LE73137; 011KY64249; 011KV57065; 011LE73145; 011KY64257; 011KV58986; 011LF36310; 011KY64269; 011KV59001; 011LQ02582; 011KY64604; 011LQ02646; 011KY64765; 011KV59969; 011KE96885 011LQ03424; 011LQ03491; 011LQ03787; 011LQ04265; 011LQ04536; 011LQ05475; 011LQ05503; 011LQ05946; 011LQ06027; 011LQ06030; 011LQ06076; 011LQ06077; 011LQ06080; 011LZ52645; 011LZ53104; 011LZ53114; 011LZ53485; 011LZ53546; 011P25067 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 68 Units B-2316-13
Red Blood Cells (Apheresis) Leukocytes Reduced 011KV59414; 011KV59414 Class II Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 2 Units B-2315-13
Blood and Blood Products for Reprocessing 011KY66486; 011LE71292; 011KY66745; 011LE68827; 011LE70329; 011LE70832; 011LQ02672; 011KY64773; 011LQ02901; 011LQ03187; 011KY64845; 011LQ03187; 011KY64848; 011KJ37754; 011KY65293; 011KV56889; 011LE71387; 011KV59977; 011LE71394; 011LE72400; 011KY63701; 011KV61312; 011KV62180; 011KY62963; 011LF36310; 011KY64269; 011KY64604; 011LQ02646; 011KY64765;011LQ03311; 011LQ03491; 011LQ03787; 011LQ04265; 011LQ04536; 011LQ05475; 011LQ05503; 011LQ05946; 011LQ06027; 011LQ06030; 011LQ06076; 011LQ06077; 011LQ06080; 011LZ52645; 011LZ53104; 011LZ53114; 011LZ53485; 011LZ53546 Class III Blood products, collected from donors, whose suitability to donate was not adequately determined, were distributed. 47 Units B-2314-13
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