BEUDAMED
    FDA Recall Terminated

    HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.

    Recall: Z-2745-2011 · Initiated May 25, 2011

    Recall

    Recall Number
    Z-2745-2011
    Event Number
    58908
    Firm
    Barrx Medical, Inc.
    FEI Number
    3004904811
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    May 25, 2011
    Posted
    July 6, 2011
    Terminated
    September 7, 2011
    Address
    540 Oakmead Pkwy, Sunnyvale, CA, 94085-4022

    Description

    HALO Ultra Ablation Catheter: Rx only; for use only with the Halo Flex Energy generator and accessories; Manufactured in the USA at BRRX Medical, 540 Oakmead Parkway, Sunnyvale, CA 94085. Product Usage: Indicated for use in the coagulation of bleeding and nod-bleeding sites in the gastrointestinal tract including but not limited to the esophagus.

    Reason

    Complaints of malfunction of the HALO ULTRA Ablation Catheter related to the device pivot mechanism's inability to return the electrode cap to a flat neutral position.

    Action

    BARRX Medical, Inc. sent a "PRODUCT RECALL NOTIFICATION" letter dated May 25, 2011 via Federal Express to all of their customers. The letter described the product, problem and actions to be taken. The customers were instructed to discontinue use of the recalled product. BRRX Medical Territory Managers will be in contact with each facility and arrange for pick up of the recalled product. The "Steps for Voluntary Recall" form that is enclosed with each letter provides customers with complete instructions on segregating the product, completing the Tracking/Verification Form, obtaining Returned Good Authorization (RGA) number and preparing product for pick up. Customers are to complete and return the Tracking/Verification Form by fax to 408-738-1741 which should include amount of product on hand, contact name and hospital/distributor information. Questions should be directed to BRRX Medical Customer Service at 888-662-2779.

    Distribution

    Worldwide Distribution -- USA (nationwide) and the countries of the United Kingdom and China

    Quantity

    936 devices