Z-1680-2014Class II

Wound Drain - Label reads in part "Elutia Hubless Coated Silicone Surgical Wound Drain" Two different...

Name: Z-1680-2014 Wound Drain - Label reads in part "Elutia ***Hubless Coated Silicone Surgical Wound Drain***" Two different...
Creator: Bacterin International, Inc.
Published: 2014-05-15
License: https://open.fda.gov/license/

Xtant Medical Holdings, Inc. / initiated 2014-05-15 / Terminated / root cause: sterility

FDA source

Bacterin International, Inc. began a recall of 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... on 2014-05-15. FDA classified it as Class II and gives the reason as "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". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as sterility.

Recall record

Recall number: Z-1680-2014
Classification: Class II
Status: Terminated
Initiated: 2014-05-15
Posted: 2014-06-02
Terminated: 2014-06-02
Recalling firm: Xtant Medical Holdings, Inc.
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.
Product code: OEI Drainage Catheter With Antibiotic
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
Root cause tag: sterility
FDA root cause: Use error
Action: Bacterin sent e-mail and FedEx letter with return receipt request to it's single consignee on May 15, 2014. Consignee is asked to separate the recalled product in a secure location for return to Bacterin International, Inc. Consignee is asked to complete tracking/verification form included in the letter/e-mail and call 1-888-886-9354 from 8:00AM to 5:00PM (Mountain Time) or send an e-mail to [email protected] to obtain a Return Authorization (RA) number.
Quantity in commerce: 390
Distribution: Distributed to one foreign consignee in Lebanon.
Product codes and lots: 19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-1680-2014
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-1680-2014	Class II	Terminated	Voluntary: Firm initiated	2014-06-11	2014-06-02

Product code OEI

K063245Class IIElutia Coated Closed Surgical Wound DrainBacterin International, Inc. / cleared 2007-11-28

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)