Events

Recall of Integra Licox Pt02 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
    69251
  • Event Risk Class
    Class 2
  • Event Number
    Z-0201-2015
  • Event Initiated Date
    2014-08-18
  • Event Date Posted
    2014-11-10
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-05-11
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=130098
  • 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 received 2 complaints that the usb port on the licox pt02 monitor does not consistently provide the user the ability to extract the pt02 trend data according to the user's manual for the device.
  • Action
    Integra LifeSciences sent an "Urgent Voluntary Medical Device Correction" letter/Return Response Form dated August 18, 2014, to their affected customers via traceable courier service. The letter identified the product the problem and the action needed to be taken by the customer. Complete the attached form. If you do not have an affected monitor, check the box: I do not have any monitors with an affected Serial Number listed below. If you do have affected monitors, check the box: I do have monitors with an affected Serial Number listed below. Circle all the Serial Numbers for the affected monitors you have and record the total quantity. Complete the other information on the form and return the form by email or fax as indicated. Keep a copy of the form for your records. When your form is received, Integra will schedule this service with your facility and provide a temporary loaner monitor to minimize any disruption this action may cause. Should you have any questions, please contact Neuro Customer Service at 1-855-532-1723. We apologize for any inconvenience this may cause and thank you for your cooperation in this effort.

Device

Integra Licox Pt02 Monitor
  • Model / Serial
    Catalogue #LCX02 - Serial #'s 2130901032, 2130901050, 2131001062, 2131001063, 2131001086, 2131001087, 2131001102, 2131001110, 2131001111, 2131001115, 2131101124, 2131101125, 2131101127, 2131101129, 2131101134, 2131101138, 2131101151, 2131101154, 2140101181, 2140301222, 2130901017, 2130901019, 2130901022, 2130901025, 2130901034, 2130901035, 2130901051, 2130901055, 2130901056, 2130901058, 2130901059, 2131001072, 2131001076, 2131001077, 2131001081, 2131001088, 2131001093, 2131001108, 2131101126, 2131101129, 2131101122, 2130901028 and 2130901039; Catalogue #LCX02R - Serial #'s 2130901038, 2130901046, 2130901054, 2131201163, 2131201164, 2131201165, 2131201166, 2131201167, 2140101170, 2140101172, 2140101174, 2140101178, 2140101179, 2140201186, 2140201189, 2140201197 and 2140401227.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Distribution including the states of : CA, DC, FL, IL, IN, MI, MN, NC, NY, PA and TX
  • Product Description
    Integra Licox Pt02 Monitor, Rx Only, Manufacturer: Integra LifeSciences (Ireland) Limited, IDA Business and Technology Park, Sragh, Tullamore, County Offaly, Ireland, Distributed by: Integra LifeSciences Corporation, 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.