Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Wound Drain - Label reads in part "Elutia ***Hubless Coated Recalled by Bacterin International, Inc. Due to The recalling firm reported there was inadvertent omission...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Bacterin International, Inc. directly.
Affected Products
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.
Quantity: 390
Why Was This Recalled?
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
Where Was This Sold?
Distributed to one foreign consignee in Lebanon.
About Bacterin International, Inc.
Bacterin International, Inc. has 5 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report