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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-0634-14
Classification Class III
Code Info SDS140312ODCN; SDS140312OSCN
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 67938
Product Type Biologics
Status Terminated
Recalling Firm DCI Donor Services dba Sierra Donor Services
City Sacramento
State CA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-04-01
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern California
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