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U.S. Department of Health and Human Services

Enforcement Report - Week of October 2, 2013

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Event Detail

Event ID 65624
Product Type Biologics
Status Terminated
Recalling Firm OneBlood, Inc.
City Hialeah
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-07
Initial Firm Notification of
Consignee or Public
Telephone
Distribution Pattern Switzerland; Florida; New York

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Fresh Frozen Plasma W036809154710; W036810117211; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 B-2376-13
Platelets Pooled Leukocytes Reduced W036809819555; W036810813443; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 B-2375-13
Red Blood Cells 2642211; W036808137145; W036809172740; W036810117211; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 4 B-2374-13
Red Blood Cells Leukocytes Reduced W036809154256; W036809154710; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 2 B-2373-13
Blood and Blood Products for Reprocessing W036808137145; W036809172740; W036809154256; Class III Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 3 B-2372-13
Platelets Leukocytes Reduced W036809154256; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 1 B-2371-13
Cryoprecipitated AHF 2642211; W036808137145; W036809172740; Class II Blood products, which were collected from a donor in which donor suitability was not adequately determined, were distributed. 3 B-2370-13
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