BEUDAMED
    FDA Enforcement Class II Terminated

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    Recall: Z-0123-2016 · Reported October 21, 2015

    Enforcement

    Recall Number
    Z-0123-2016
    Event ID
    72018
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Innovations, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    N/A
    Report Date
    October 21, 2015
    Initiation Date
    January 5, 2015
    Classification Date
    October 15, 2015
    Termination Date
    April 21, 2016
    Address
    747 W 4170 S, N/A, Murray, UT, 84123-1364, United States

    Description

    The Ebb Complete Tamponade System, model #CTS-1000 and Code #OQY. Intended for use in providing temporary control or reduction of postpartum uterine bleeding.

    Reason

    Clinical Innovations, LLC is voluntarily recalling the Ebb Complete Tamponade System (CTS-1000) Lot Number 1214-F-403.) to address the potential for a balloon leak which may affect the ability to deliver therapy, when needed.

    Code Info

    Manufacturing lot 1214-F-403 and 1214-V-424

    Distribution

    Nationwide to MS, MD, TN, NC, IN, FL, AL, and LA, and to France.

    Quantity

    827 units