Events

Recall of Device Recall Elutia Hubless Coated Silicone 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
    64326
  • Event Risk Class
    Class 2
  • Event Number
    Z-0936-2013
  • Event Initiated Date
    2013-01-28
  • Event Date Posted
    2013-03-11
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2013-07-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=115836
  • 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
    A portion of a silicone wound drain was found to be cracked.
  • Action
    Consignees were informed of the recall via e-mail beginning 1/28/13 with a request for a return response. This was followed by a "Voluntary Product Recall Information" letter dated 2/13/13 that described the product issue and provided recommended actions. The firm asked for all product to be returned to them.

Device

Device Recall Elutia Hubless Coated Silicone Wound Drain
  • Model / Serial
    005312; 011012; 012111; 012311; 012511; 013011; 019212; 023611; 023811; 024011; 024211; 025912; 033611; 042211
  • Product Classification
    General and Plastic Surgery Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    13 US consignees located in CA, CO, MT, TX, UT, and VA. This represents 4 customers and 9 other individual contacts in USA that received marketing samples. Plus 4 Bacterin representives nationwide received samples. Foreign Consingee
  • Product Description
    Bacterin Elutia, Hubless Coated Silicone Surgical Wound Drain 24 Fr Round Hubless, Full-Fluted Coated with Silver Sulfadiazine STERILE, Box of 10 Part #7118. Indicated for use in surgical wound drainage.
  • 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