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U.S. Department of Health and Human Services

Enforcement Report - Week of August 8, 2012

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Event Detail

Event ID 61324
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 2012-01-13
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Cario, Egypt

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Cornea 20110475OS, 20110475OD Class II Human corneas, recovered from a donor whose donor eligibility was initially determined with inaccurate and/or incomplete donor records, were distributed. 2 B-2150-12
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