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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Event Detail

Event ID 58498
Product Type Biologics
Status Terminated
Recalling Firm Community Blood Center of Carolinas
City Charlotte
State NC
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-03-15
Initial Firm Notification of
Consignee or Public
Distribution Pattern NC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced F42212, F42011, F42013,F42665, F44512, F44519, F42347, F41185, F42146, F42057, F42592, F42913, F42602, F41718, F43037, F42673, F42663, F43013, F42502, F42200, F42410, F42144, F43012, F42912, F42054, F43082, F42889, F43233, F43501, F43509, F43651, F43657, F41186, F41187, F43678, F41897, F41944, F42206, F42209, F42210, F42213, F42214, F42219, F42222, F42227, F42228, F42252, F42355, F35840, F41695, F41698, F41699, F42122, F42127, F42128, F42129, F42391, F42394, F42400, F42407, F42010, F42015, F42018, F42019, F42023, F42024, F42033, F42034, F42035, F42036, F42038, F42045, F42050, F42243, F42244, F42245, F42247, F42248, F42250, F42270, F42413, F43005, F41712, F42136, F42137, F42139, F42140, F42142, F42145, F42149, F42150, F42276, F42277, F42281, F42503, F42505, F43014, F43019, F43021, F43024, F41715, F41716, F41722, F42305, F42307, F42521, F42907, F42917, F42922, F43028, F43029, F43030, F43033, F43048, F43049, F43056, F42066, F42348, F42601, F42603, F42607, F42709, F42749, F42998, F43070, F43073, F43078, F42664, F42667, F42668, F42672, F42674, F42675, F41179, F41181, F42754, F42756, F42888, F42891, F42893, F43231, F43234, F43236, F43240, F43244, F43278, F43291 Class III Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed. 147 units B-0360-13