BEUDAMED
    FDA Enforcement Class II Ongoing

    Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.

    Recall: Z-0124-2020 · Reported October 23, 2019

    Enforcement

    Recall Number
    Z-0124-2020
    Event ID
    83831
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Integra LifeSciences Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Visit
    Report Date
    October 23, 2019
    Initiation Date
    September 12, 2019
    Classification Date
    October 12, 2019
    Address
    311 Enterprise Dr, N/A, Plainsboro, NJ, 08536-3344, United States

    Description

    Cerelink ICP Monitor, Model Number 826820; intended for use as an interface between compatible strain-gauge type pressure transducers and standard physiological pressure monitoring systems.

    Reason

    There is a potential for a progressive decline in observed ICP readings of the monitor during use.

    Code Info

    All systems

    Distribution

    The products were distributed to the following US states: CA, CO, CT, FL, IN, NY, OK, PA, TX, WI, and WV. The products were distributed to the following foreign countries: Australia, Belgium.

    Quantity

    189