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U.S. Department of Health and Human Services

Enforcement Report - Week of June 18, 2014

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Event Detail

Event ID 68060
Product Type Biologics
Status Terminated
Recalling Firm HCSC-Blood Center
City Bethlehem
State PA
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-02-19
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern PA, NJ

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Red Blood Cells W050911079014; W050911082588 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 units B-0666-14
Red Blood Cells Leukocytes Reduced Irradiated W050911075248 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0665-14
Platelets Pheresis Leukocytes Reduced W050911079028 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 unit B-0664-14
Fresh Frozen Plasma W050911075248 Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 units B-0667-14
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