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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Event Detail

Event ID 68305
Product Type Devices
Status Terminated
Recalling Firm Bacterin International, Inc.
City Belgrade
State MT
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2014-05-15
Initial Firm Notification of
Consignee or Public
Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Distribution Pattern Distributed to one foreign consignee in Lebanon.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 units per box: 19 Fr Round Hubless part number 7110; 24 Fr Round Hubless part number 7118. AC-powered or compressed air-powered device intended to be used to remove infectious materials from wounds or fluids from a patient's airway or respiratory support system. 19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213.. Class II The recalling firm reported there was inadvertent omission of quarterly (Q4 - 2013 and Q1 - 2014) dose audits/verifications on the affected products. All of the affected products were appropriately sterilized 390 Z-1680-2014