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U.S. Department of Health and Human Services

Enforcement Report - Week of March 20, 2013

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Event Detail

Event ID 50951
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 2008-12-04
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Ohio, California.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells Leukocytes Reduced 42 FZ34322, 42 FZ34323, 42 FZ34325, 42 FZ34328, 42 FY90934, 42 FY90942, 42 FY90943, 42 FY90947, 42 FY90954, 42 FY90990, 42 FY90993, 42 G76618, 42 G76631, 42 G76632, 42G 76644, 42 G 76646, 42 R05856, 42 R05859, 42 R 05863, 42 R05872, 42 R05877, 42 R05880, 42 K06759, 42 K06764, 42K06775, 42K06777, 42 K06781, 42 K06794, 42 FR54630, 42 S41166, 42 S41235, 42 S41239, 42 S41242, 42 S41247, 42 FG41438 Class II Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed. 35 units B-0584-13
Platelets Leukocytes Reduced 42 FY90992, 42 FY90993, 42 R05863, 42 R05877, 42R05880, 42 S41235, 42 S41239, 42 S41247, 42 K06775, 42 K06777, 42 K06794, 42FH67049 Class II Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed. 12 units B-0586-13
Platelets Pooled Leukocytes Reduced 25612, 25600,25607, 25634, 25694, 25713, 25731, 25781, 25938, 26009, 26036 Class II Blood products, which were collected without applying the metal crimp and potentially cause contamination to the blood, were distributed. 11 units B-0587-13
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