BEUDAMED
    FDA Enforcement Class II Terminated

    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.

    Recall: Z-1620-2015 · Reported May 27, 2015

    Enforcement

    Recall Number
    Z-1620-2015
    Event ID
    71027
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 27, 2015
    Initiation Date
    April 14, 2015
    Classification Date
    May 15, 2015
    Termination Date
    December 12, 2017
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    The Integra Licox Pt02 Monitors are compact, portable device for use with Pressure/Temperature, Pressure and Oxygen Partial Pressure Transducer-Tipped Catheters. The LCX02R monitor measures and displays oxygen partial pressure and temperature in tissue.

    Reason

    Integra LifeSciences Corporation is recalling Integra's Camino ICP Monitor (CAM 02) & Licox PtO2 Monitor ( LCX02 & LCX02R) due to complaints that the audible speaker malfunctions.

    Code Info

    All Lots

    Distribution

    Worldwide Distribution.

    Quantity

    59 monitors