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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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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
Distribution Pattern NC, Egypt

Product Detail

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