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U.S. Department of Health and Human Services

Enforcement Report - Week of July 17, 2013

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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

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Amniotic membrane 2012AG1510F06969, 2012AG1510F06970, 2012AG1510F06974, 2012AG1510F06976, 2012AG1510F06977, 2012AG1510F06979, 2012AG1510F06980, 2012AG1510F06981, 2012AG1510F06984, 2012AG1510F06988, 2012AG1510F06991, 2012AG1510F06992, 2012AG1510F06994, 2012AG1510F07000, 2012AG1510F07001, 2012AG1510F07002, 2012AG1510F07005, 2012AG1510F07007, 2012AG1510F07008, 2012AG1510F07010, 2012AG1510F07011, 2012AG1510F07012, 2012AG1510F07019, 2012AG1510F07020, 2012AG1510F07021, 2012AG1510F07025, 2012AG1510F07026, 13NX10252500019, 2012AG1510F06978, 2012AG1510F06993, 2012AG1510F07003, 2012AG1510F07004, 2012AG1510F07014, 2012AG1510F07015, 2012AG1510F07016, 2012AG1510F07017, 2012AG1510F07018, 2012AG1510F06971, 2012AG1510F06972, 2012AG1510F06973, 2012AG1510F06975, 2012AG1510F06982, 2012AG1510F06983, 2012AG1510F06985, 2012AG1510F06986, 2012AG1510F06987, 2012AG1510F06989, 2012AG1510F06990, 2012AG1510F06995, 2012AG1510F06997, 2012AG1510F06998, 2012AG1510F06999, 2012AG1510F07006, 2012AG1510F07009, 2012AG1510F07013, 2012AG1510F07022, 2012AG1510F07023, 2012AG1510F07024 Class II Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. 58 B-1847-13
Amniotic membrane 12NX10252500519, 12NX10252500520 Class III Amniotic membrane allografts, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were distributed. 2 B-1846-13
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