BEUDAMED
    FDA Enforcement Class II Terminated

    Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

    Recall: Z-2072-2020 · Reported May 27, 2020

    Enforcement

    Recall Number
    Z-2072-2020
    Event ID
    85170
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Innovations, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    May 27, 2020
    Initiation Date
    August 6, 2019
    Classification Date
    May 21, 2020
    Termination Date
    September 16, 2022
    Address
    747 W 4170 S, N/A, Murray, UT, 84123-1364, United States

    Description

    Kiwi Complete Vacuum Delivery System, Model No. VAC-6000MTE - Product Usage: The Kiwi is a disposable vacuum-assisted fetal delivery system.

    Reason

    There is a potential for loss of vacuum or failure to generate vacuum when using the firm's fetal vacuum delivery system.

    Code Info

    Model No. VAC-6000MTE, lot no. 181144; UDI: 00814247020659

    Distribution

    OUS customers only.

    Quantity

    2340 Units