BEUDAMED
    FDA Recall Terminated

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.

    Recall: Z-3149-2011 · Initiated April 15, 2011

    Recall

    Recall Number
    Z-3149-2011
    Event Number
    58613
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 15, 2011
    Posted
    September 6, 2011
    Terminated
    September 13, 2011
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook Medical Zenith Flex AAA Endovascular Graft Iliac Leg, REF TFLE-20-90-ZT, REF G48471, 16Fr ID/ 6.0 mm OD, Sterile.

    Reason

    The firm initiated this action in response to information that there may be potential damage in the braided suture which is used to attach the external stents to the graft material.

    Action

    The firm sent URGENT PRODUCT RECALL notices dated 4/15/2011 to Risk Managers/Recall Administration (Chief of Vascular Surgery and or Interventional Radiology). The letters explained the problem with the devices and the action to be taken. Consignees were instructed to return the recalled devices to Cook Medical for credit or replacement. Customers with questions or concerns can contact the firm at 800-457-2235.

    Distribution

    US, Canada, Japan

    Quantity

    3 units