Bacterin International, Inc.: Medical Device Recall in 2014 - (Recall #: Z-1680-2014)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2014.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: May 15, 2014

Date Posted: June 11, 2014

Recall Number: Z-1680-2014

Event ID: 68305

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

Status: Terminated

Product Quantity: 390

Code Information:

19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..

Distribution Pattern:

Distributed to one foreign consignee in Lebanon.

Voluntary or Mandated:

Voluntary: Firm initiated