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U.S. Department of Health and Human Services

Enforcement Report - Week of May 28, 2014

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Product Detail

Product Description Cornea
Recall Number B-0635-14
Classification Class II
Code Info 111710ODC; 111710OSC
Product Distributed Qty 2 corneas
Reason For Recall Human corneas, recovered from a donor 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.

Event Detail

Event Id 68054
Product Type Biologics
Status Terminated
Recalling Firm Minnesota Lions Eye Bank, Inc
City Saint Paul
State MN
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-11
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Minnesota
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