BEUDAMED
    FDA Enforcement Class II Terminated

    Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580

    Recall: Z-2050-2017 · Reported May 17, 2017

    Enforcement

    Recall Number
    Z-2050-2017
    Event ID
    76972
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Mederi Therapeutics, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 17, 2017
    Initiation Date
    April 3, 2017
    Classification Date
    May 8, 2017
    Termination Date
    October 10, 2017
    Address
    800 Connecticut Ave Ste 1E01, N/A, Norwalk, CT, 06854-1628, United States

    Description

    Mederi Stretta Catheter and Accessory Kit, Sterile For Use with the MEDERI MDRF1 GENERATOR ONLY. Used in the treatment of gastroesophageal reflux disease (GERD). REF 175-5580

    Reason

    Product sterility compromised due to breach in sterile barrier package

    Code Info

    Lot Numbers: 291ST-16 102ST-16 102ST-16R-1 102ST-16R-2 116ST-16R 116ST-16R2 116ST-16R3 116ST-16R4 139ST-16 139ST-16-1 139ST-16-2 139ST-16-3 144ST-16 209ST-16 227ST-16 243ST-16 276ST-15 286ST-16 290ST-16 291ST-16 299ST-16 306ST-16 310ST-15

    Distribution

    Worldwide Distribution - Nationwide Distribution and to the countries of: Turkey, Great Britain, Belgium, Kuwait, Poland, Italy, India, China, Costa Rica, Australia, Malaysia, Jordan and Egypt.

    Quantity

    1458 units