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U.S. Department of Health and Human Services

Enforcement Report - Week of September 11, 2013

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Event Detail

Event ID 38803
Product Type Biologics
Status Terminated
Recalling Firm American National Red Cross (The)
City Cleveland
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2007-03-01
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Ohio, Switzerland

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Recovered Plasma 42FT70229, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690 Class III Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 10 units B-2243-13
Platelets Pooled Leukocytes Reduced 42FT70246, 42FT70255, 42FT70306, 42FX56668, 42FX56674, 42FX56684, 42FX56690 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 7 units B-2242-13
Red Blood Cells Leukocytes Reduced 42FT70229, 42FT70233, 42FT70246, 42FT70255, 42FT70267, 42FT70306, 42FX56668, 42FX56674, 42FX56676, 42FX56684, 42FX56690 Class II Blood products, collected in a manner that may have compromised the sterility of the units, were distributed. 11 units B-2241-13
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