BEUDAMED
    FDA Enforcement Class II Terminated

    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

    Recall: Z-1014-2015 · Reported February 4, 2015

    Enforcement

    Recall Number
    Z-1014-2015
    Event ID
    70137
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Clinical Innovations, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 4, 2015
    Initiation Date
    December 30, 2014
    Classification Date
    January 27, 2015
    Termination Date
    December 28, 2015
    Address
    747 W 4170 S, N/A, Murray, UT, 84123-1364, United States

    Description

    Ebb Complete Tamponade System, BD-OTS Obstetric Catheter, REF CTS-1000, Rx Only, Sterile EO

    Reason

    Potential for a balloon leak in all lots of (CTS-1000) manufactured since August 2014.

    Code Info

    Lots: 0314-F-566; 0814-F-100; 0814-F-108; 0814-V-068

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of : Canada, Finland, Estonia, Belgium, Ireland, Sweden, France, Switzerland, Spain, Netherlands, Middle East, Scotland, Germany and Wales.

    Quantity

    827 units