Events

Recall of Device Recall Elutia Surgical Wound Drain

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Bacterin International, Inc..

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    68305
  • Event Risk Class
    Class 2
  • Event Number
    Z-1680-2014
  • Event Initiated Date
    2014-05-15
  • Event Date Posted
    2014-06-02
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-06-02
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127311
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Drainage catheter with antibiotic - Product Code OEI
  • Reason
    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.
  • 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 CS@Bacterin.com to obtain a Return Authorization (RA) number.

Device

Device Recall Elutia Surgical Wound Drain
  • Model / Serial
    19 Fr Round Hubless part number 7110 lot number 016913; 24 Fr Round Hubless part number 7118 lot numbers 028013, 028113 and 028213..
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Distributed to one foreign consignee in Lebanon.
  • 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.
  • Manufacturer
    Bacterin International, Inc.

Manufacturer

Bacterin International, Inc.
  • Manufacturer Address
    Bacterin International, Inc., 600 Cruiser Ln, Belgrade MT 59714-9719
  • Manufacturer Parent Company (2017)
    Xtant Medical Holdings, Inc.
  • Source
    USFDA