Events

Recall of Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Integra LifeSciences Corp..

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
    65742
  • Event Risk Class
    Class 2
  • Event Number
    Z-0057-2014
  • Event Initiated Date
    2013-06-11
  • Event Date Posted
    2013-10-23
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2014-02-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=120017
  • 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
    Device, monitoring, intracranial pressure - Product Code GWM
  • Reason
    Integra lifesciences corporation has determined that there is a possibility that some lots of licox cmp brain tissue oxygen and temperature catheter kits contain a hex wrench that does not loosen the set screw on the drill bit.
  • Action
    Integra LifeSciences Corporation sent a recall letter/return response form on 6/11/2013 by traceable courier service, traceable e-mail or facsimile.

Device

Device Recall Integra Licox Brain Tissue Oxygen Monitoring Kit
  • Model / Serial
    K040244  Lot #190712; 240512;280612
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide distribution: US (nationwide) and countries of: AR, BR, CH, CL,CR. DE, ES, FI, FR, GB, IL, IT, MX, PA, PL, PT, RU, TW, and ZA.
  • Product Description
    Inegra Licox Brain Tissue Oxygen Monitoring || 1 x Complete Brain Tunneling Probe Kit || REF IT2 || Rx Only, Manufacturer GMS- Gesellschaft fur medizinische, Sondentechnik mbH Dofstrasse 2 24247 Melkendorf, Germany || Distributed by Integra Neurosciences 311 Enterprise Drive Plainsboro, NJ 08536 USA || Used in direct monitoring of the partial pressure of oxygen.
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.