Events

Recall of Device Recall LICOX Brain Oxygen Monitoring System

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
    69803
  • Event Risk Class
    Class 2
  • Event Number
    Z-0831-2015
  • Event Initiated Date
    2014-11-07
  • Event Date Posted
    2014-12-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-08-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=131571
  • 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
    Due to a complaint, it was determined that multiple lots of licox catheters manufactured since october 29, 2013 contained a smart card which was programmed with an inaccurate lkn2 value.
  • Action
    Integra sent Urgent- Voluntary Medical Device Recall Letters/Recall Acknowledgement and Return Form dated 11/7/2014 to customers and distributors via traceable courier service.

Device

Device Recall LICOX Brain Oxygen Monitoring System
  • Model / Serial
    CC1  Licox¿ PO2 Microprobe, 200 mm 021213, 040414, 070314, 130114, 240214, 270114, 280314, 300614  CC12  Licox¿ PO2 Microprobe, 300 mm  020614, 040814, 050514, 070414, 070714, 220414  CC1.P1 Licox¿ PMO Combined Probe Containing Oxygen and Temperature 050614, 060214, 060314, 100414, 100714, 130214, 130314, 170114, 190614, 210814, 260614, 310714  IM3ST Licox¿ Complete Brain IMC-Probe Kit: 020614, 030314, 110714, 130114, 140314, 160614, 180714, 200114, 280314  IP1.P Licox¿ Single Lumen Bolt CMPS and Temperature Bolt Kit 030714, 060214, 060314, 070814, 080514, 100714, 120614, 130314, 190614, 310714  IP2.P Licox¿ Double Lumen Bolt CMPS, Temperature and ICP Monitoring Kit 030714, 050614, 060214, 060314, 070814, 080514, 090114, 100714, 130314, 140814, 200214, 200414, 260614, 290814  IT2 Licox¿ Tunneling CMPS and Temperature Monitoring Kit 090114, 100414, 190614, 200214, 260614, 310714
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Nationwide, Foreign
  • Product Description
    Integra Licox Brain Tissue Oxygen Monitoring || Integra Licox Recon Tissue Oxygen Monitoring || 1) LICOX¿ Complete Brain Probe Kit (comprised of IP1, CC1.P1) || 2) LICOX¿ Complete Brain Probe Kit (comprised of IP2, CC1.P1) || 3) LICOX¿ Complete Brain Tunnelling Probe Kit (comprised of VK5.2, CC1.P1 || 4) LICOX¿ Complete Brain Probe Kit (comprised of IM1, CC1.SB) || Sterile Rx Only || Manufacturer CMS -Gesse;schaft for medizinische Sondentechnik mbH Dorfstrasse 2 24247
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.