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U.S. Department of Health and Human Services

Enforcement Report - Week of September 12, 2012

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Event Detail

Event ID 40074
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Saint Louis
State MO
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2005-04-15
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern MO, IL, TN, AR, AL, PR, SC

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Plasma Frozen . 011GK83748 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-2442-12
Red Blood Cells. . 011GQ72533 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 1 UNIT B-2441-12
Recovered Plasma 011FL31346, 011FL31353, 011FL31376, 011GG39708, 011GK83777, 011GN80908, 011GN80912, 011GN80914, 011GN80919, 011GN80937, 011GN80938, 011GN80941, 011GN80946, 011GN80949, 011GQ72540, 011GQ72541, 011GQ72545, 011GQ72547, 011GQ72548, 011GR66347, 011GR66349, 011GR66353, 011GR66357, 011GR66359, 011GR66361, 011GR66362, 011GR66363, 011GR66387 Class III Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 28 units B-2440-12
Fresh Frozen Plasma. 011GJ65355, 011GK83777, 011GM89839, 011GM89842, 011GM89844, 011GM89849, 011GR66380 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 7 units B-2439-12
Cryoprecipitated AHF. . 011FL31370, 011FL31376, 011FL31413, 011FS35106, 011FS36117, 011FS35118, 011GG39706, 011GG39708, 011GN80937, 011GN80938, 011GN80941, 011GN80946, 011GN80949, 011GQ72533, 011GQ72541, 011GQ72543, 011GQ72545, 011GQ72547, 011GQ72548 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 19 UNITS B-2438-12
Red Blood Cells Leukocytes Reduced. 011FL31359, 011FL31370, 011FL31413, 011FL31424, 011FS36104, 011FS35106, 011FS36117, 011FS35118, 011FS36121, 011GG39706, 011GG39708, 011GJ65355, 011GK83746, 011GH83753, 011GK83767, 011GK83774, 011GK83775, 011GK83779, 011GM89817, 011GM89820, 011GM89821, 011GM89825, 011GM89826, 011GM89839, 011GM89842, 011GM89851, 011GN80908, 011GN80912, 011GN80914, 011GN80916, 011GN80919, 011GN80937, 011GN80938, 011GN80941, 011GN80949, 011GQ72541, 011GQ72543, 011GQ72545, 011GQ72547, 011GQ72548, 011GR66347, 011GR66349, 011GR66353, 011GR66357, 011GR66359, 011GR66361, 011GR66362, 011GR66363, 011GR66380, 011GR66387 Class II Blood products, collected from a donor in which donor suitability was not adequately determined, were distributed. 50 UNITS B-2437-12
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