Events

Recall of Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P;

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
    56820
  • Event Risk Class
    Class 2
  • Event Number
    Z-0161-2011
  • Event Initiated Date
    2010-09-15
  • Event Date Posted
    2010-10-28
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-04-18
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=94583
  • 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
    Incorrect expiration date - the outer boxes of the ip2p licox complete kit for cerebral pressure, temperature and icp monitoring probes, lot 250210a are labeled with an incorrect shelf life date (10 months too long).
  • Action
    Integra issued Urgent Product Recall Notification letters dated September 16, 2010 to US customers and foreign consignees, identifying the affected lots and actions to be taken by customers. Affected product is not to be further distributed and should be quarantined pending return to the firm. Customers and Distribors should contact Integra Customer Service for a Returned Material Authorization Number, and then return the product to the Distribution Center. In addition, a Recall Acknowledgement and Return Form is to be completed and returned. Customers can contact Integra at 609 936-2495.

Device

Licox Brain PMO Probe Kit; for Cerebral Pressure, Ref IP2.P;
  • Model / Serial
    Ref IP2P, Lot number: 250210A; Serial Numbers: 833, 834, 835, 836, 837, 838, 839, 841, 844, 846, 847, 848, 850, 851, 852, 853, 854, 855, 857, 858, 859, 860, 861, 862, 864.
  • Product Classification
    Neurological Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution: USA, including the states of FL, ID, IL, and NJ, and the countries of Argentina and Costa Rica.
  • Product Description
    Licox Brain PMO Probe Kit; || Ref IP2.P; || Multiparameter Monitoring Oxygen + ICP Channel: Contain Products: REF IP2 Bolt kit for 2 brain probes, Ref CC1.P1 combined Oxygen & Temperature probe; || Contains sterile and non-pyrogenic if package is unopened and undamaged. || Integra US, 311 Enterprise Drive, Plainsboro, NJ 08536
  • Manufacturer
    Integra LifeSciences Corp.

Manufacturer

Integra LifeSciences Corp.