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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 65521
Product Type Biologics
Status Terminated
Recalling Firm International Sight Restoration, Inc.
City Tampa
State FL
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-06-05
Initial Firm Notification of
Consignee or Public
E-Mail
Distribution Pattern Egypt; Lebanon; Argentina; Mexico; Romania; South Africa; Iraq

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 20120136OD; 20120136OS Class II Human corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 2 corneas B-2282-13
Cornea 20130020OD; 20130020OS; 20130040OD; 20130040OS; 20130040ODSW; 20130040OSSW; 20130073OD; 20130073OS; 20130077OD; 20130077OS Class III Human corneas, recovered from donors whose donor eligibility determination failed to ensure that the donor was free from risk factors for, and clinical evidence of infection due to relevant communicable disease agents and diseases, were distributed. 10 corneas B-2281-13
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