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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Product Detail

Product Description South Dakota Lions Eye Bank, Cornea, SD11-079, For single use only, Not considered sterile, Culturing Recommended.
Recall Number B-2313-12
Classification Class II
Code Info SD11079OD; SD11079OS
Product Distributed Qty 2
Reason For Recall Human Corneas, recovered from a donor who had not been properly evaluated, were distributed.

Event Detail

Event Id 62304
Product Type Biologics
Status Terminated
Recalling Firm South Dakota Lions Eye and Tissue Bank, Inc.
City Sioux Falls
State SD
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-04-27
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern NC, Egypt