BEUDAMED
    FDA Enforcement Class II Terminated

    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

    Recall: Z-1106-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1106-2020
    Event ID
    84611
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Cardiac Assist, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    February 19, 2020
    Initiation Date
    November 19, 2019
    Classification Date
    February 7, 2020
    Termination Date
    October 7, 2020
    Address
    240 Alpha Dr, Pittsburgh, PA, 15238-2906, United States

    Description

    TandemLife ECLS Procedure Kit - V24/A17, Catalog Number 5740-2417 - Product Usage: The function of the 24Fr ProtekSolo Venous Cannula is to provide a conduit for blood to travel from the patient s venous system when connected to accessory extracorporeal equipment. The Venous Cannula is intended to cannulate vessels, perfuse vessels or organs and/or connect with accessory extracorporeal circulatory support equipment. The introducer is intended to facilitate proper insertion and placement of the cannula within the vessel for extracorporeal circulatory support. These devices are to be used by a trained physician only.

    Reason

    The kit contained a 29Fr ProtekDuo cannula instead of a 24Fr Protek Solo Venous cannula.

    Code Info

    Serial Number/UDI 141445/ (01)00814112020517(17)200825(11)190423(21)00141445, 141446/ (01)00814112020517(17)200825(11)190423(21)00141446, 141447/ (01)00814112020517(17)200825(11)190423(21)00141447, 141448/ (01)00814112020517(17)200825(11)190423(21)00141448, 141449/ (01)00814112020517(17)200825(11)190423(21)00141449, 141450/ (01)00814112020517(17)200825(11)190423(21)00141450, 141451/ (01)00814112020517(17)200825(11)190429(21)00141451, 141452/ (01)00814112020517(17)200825(11)190429(21)00141452, 141453/ (01)00814112020517(17)200825(11)190429(21)00141453, 141454/ (01)00814112020517(17)200825(11)190429(21)00141454, 141457/ (01)00814112020517(17)200825(11)190429(21)00141457 Expiration Date for all products - August 25, 2020

    Distribution

    US Nationwide distribution in the states of AZ, AL, ME, LA, PA.

    Quantity

    11 kits