BEUDAMED
    FDA Recall Terminated

    G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J

    Recall: Z-0393-2007 · Initiated December 20, 2006

    Recall

    Recall Number
    Z-0393-2007
    Event Number
    37021
    Firm
    Bard Peripheral Vascular Inc
    FEI Number
    2020394
    Product Code
    DTK
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2006
    Posted
    February 1, 2007
    Terminated
    October 23, 2008
    Address
    1625 W 3rd St, Tempe, AZ, 85281-2438

    Description

    G2 Filter System - Jugular/Subclavian Delivery Kit, for use in the prevention of recurrent pulmonary embolism. Catalog Number RF-320J

    Reason

    This action is being taken because BPV has recently received three complaints for the device that involve reports of introducer sheath tip damage. The damage may result in loss of tip integrity.

    Action

    Recall letters were sent to all consignees via Federal Express overnight delivery with signature receipt required on December 20, 2006. Each letter included a Recall and Effectiveness Check Form for each consignee to fill out and fax to Bard Peripheral Vascular, Inc (BPV). Customers will be asked to immediately remove product from inventory and isolated from use and contact BARD for return authorization. All returned product will be destroyed.

    Distribution

    Worldwide including USA, Australia, and Canada

    Quantity

    5761 units