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U.S. Department of Health and Human Services

Enforcement Report - Week of June 11, 2014

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Product Detail

Product Description 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.
Recall Number Z-1680-2014
Classification Class II
Code Info 19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
Product Distributed Qty 390
Reason For Recall 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

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.