BEUDAMED
    FDA Enforcement Class II Terminated

    Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1

    Recall: Z-1849-2019 · Reported June 26, 2019

    Enforcement

    Recall Number
    Z-1849-2019
    Event ID
    82894
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Stryker GmbH
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 26, 2019
    Initiation Date
    April 30, 2019
    Classification Date
    June 20, 2019
    Termination Date
    September 18, 2020
    Address
    Bohnackerweg 1, N/A, Selzach, N/A, N/A, Switzerland

    Description

    Endotrac EPF/EGR Hook/Triangle Blade Kit, Catalogue Number 3056-1

    Reason

    The seal integrity of the sterile bag containing the kits may be compromised.

    Code Info

    Lot #s 01404, 01478

    Distribution

    The products were distributed US nationwide.

    Quantity

    1600