BEUDAMED
    FDA Recall 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 · Initiated January 5, 2015

    Recall

    Recall Number
    Z-0123-2016
    Event Number
    72018
    Firm
    Clinical Innovations, LLC
    FEI Number
    1000220650
    Product Code
    OQY
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 5, 2015
    Posted
    October 15, 2015
    Terminated
    April 21, 2016
    Address
    747 W 4170 S, Murray, UT, 84123-1364

    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.

    Action

    Consignees were notified via email on 08/21/15. All consignees were asked to acknowledge the recall and return devices.

    Distribution

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

    Quantity

    827 units