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U.S. Department of Health and Human Services

Enforcement Report - Week of November 28, 2012

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Product Detail

Product Description Red Blood Cells Leukocytes Reduced
Recall Number B-0360-13
Classification Class III
Code Info 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
Product Distributed Qty 147 units
Reason For Recall Blood products, which were not manufactured in accordance to acceptable product specifications, were distributed.

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 Letter
Distribution Pattern NC