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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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Product Detail

Product Description Amniotic membrane
Recall Number B-1846-13
Classification Class III
Code Info 12NX10252500519, 12NX10252500520
Product Distributed Qty 2
Reason For Recall Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed.

Event Detail

Event Id 65189
Product Type Biologics
Status Terminated
Recalling Firm TissueTech, Inc. dba Bio-Tissue, Inc.
City Miami
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-03-18
Initial Firm Notification of Consignee or Public Telephone
Distribution Pattern Nevada; Illinois; New Mexico; Arizona; Alabama; Oregon; Ohio; Florida; California; Washington; Louisiana; Texas
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