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Bacterin International, Inc. recalls Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different sizes, 10 u
Recalled June 11, 2014 · FDA recall Z-1680-2014 · Bacterin International
Hazard
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 · FDA Class II
Units
390
Sold at
Distributed to one foreign consignee in Lebanon.
Description
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
Product
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.
Manufacturer(s)
Bacterin International, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →