BEUDAMED
    FDA Recall Terminated

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-82.

    Recall: Z-0501-05 · Initiated December 20, 2004

    Recall

    Recall Number
    Z-0501-05
    Event Number
    30721
    Firm
    Cook, Inc.
    FEI Number
    1820334
    Product Code
    MIH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    December 20, 2004
    Posted
    February 3, 2005
    Terminated
    December 2, 2005
    Address
    750 Daniels Way, Bloomington, IN, 47404-9120

    Description

    Cook brand Zenith Flex AAA Endovascular graft with the H&L-B One-Shot Introduction System( A= 28mm, B=112mm, C=82mm, D=12mm, E= 20.0f, F=.035'', G =40cm); Reorder number TFBB-28-82.

    Reason

    The firm has received complaints of difficulty in releasing the barbed suprarenal stent from the top cap that constrains it, which may result in misplacement of the graft.

    Action

    Recall letter dated 12/20/04 was issued to each consignee via FedEx instructing them to cease using the products and to return them to the firm.

    Distribution

    Nationwide and Canada.