Events

Recall of Integra Camino ICP Monitor

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
    71027
  • Event Risk Class
    Class 2
  • Event Number
    Z-1618-2015
  • Event Initiated Date
    2015-04-14
  • Event Date Posted
    2015-05-15
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-12-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135877
  • 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 is recalling integra's camino icp monitor (cam02) & licox pto2 monitor ( lcx02 & lcx02r) due to complaints that the audible speaker malfunctions.
  • Action
    Integra initiated this recall by sending an Urgent Voluntary Medical Device Recall Letter/Recall Acknowledgement Form dated 4/14/15 via traceable courier service to their affected customers.

Device

Integra Camino ICP Monitor
  • Model / Serial
    All Lots
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution.
  • Product Description
    The Integra Camino ICP Monitor is a compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. || The CAM02 monitor measures and displays intracranial ICP) and intracranial temperature (ICT).
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.