BEUDAMED
    FDA Recall 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 · Initiated April 3, 2017

    Recall

    Recall Number
    Z-2050-2017
    Event Number
    76972
    Firm
    Mederi Therapeutics, Inc
    FEI Number
    3007729452
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    April 3, 2017
    Terminated
    October 10, 2017
    Address
    800 Connecticut Ave, Ste 1E01, Norwalk, CT, 06854-1628

    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

    Action

    Mederi issued initial recall on March 29, 2017, and on April 3, 2017, with a corrected recall letter requesting users identify product and set aside for an inspection by Mederi personnel. Once the inspection is completed return the Acknowledgement Form Customer Service, return via eFax at 888-215-9883, or email to [email protected]. Mederi will provide FedEx labels and ensure appropriate packaging for the return. For further questions, please call (203) 930-9900.

    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