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U.S. Department of Health and Human Services

Enforcement Report - Week of March 6, 2013

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Event Detail

Event ID 64205
Product Type Biologics
Status Terminated
Recalling Firm Lions Eye Institute for Transplant & Research, Inc.
City Tampa
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-11
Initial Firm Notification of
Consignee or Public
Letter
Distribution Pattern Indonesia; Egypt; Mexico; Saudi Arabia; Florida; Missouri; New Jersey; Dominican Republic

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 2012010601; 2012032093; 2012042243; 2012042299; 2012053203; 2012053261; 2012064195; 2012074467; 2012074497; 2012074999; 2012085207; 2012096095; 2012106947; 2012107037; 2012107087; 2012107203; 2012107253; 2012128065; 2012128281; 2012128317; 2011127530; 2011127666; 2012010602; 2012032094; 2012042244; 2012042300; 2012053204; 2012053262; 2012064196; 2012074468; 2012074498; 2012075000; 2012085208; 2012096096; 2012106948; 2012107038; 2012107088; 2012107204; 2012107254; 2012117420; 2012128066; 2012128282; 2012031727; 2012021505; 2012021506; 2012021291; 2012021292; 2011127529; 2011127665 Class II Human Corneas, recovered from a donor whose donor screening may have been performed in a manner that did not determine the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 49 B-0970-13
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