BEUDAMED
    FDA Recall Terminated

    FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24.

    Recall: Z-0216-04 · Initiated November 25, 2003

    Recall

    Recall Number
    Z-0216-04
    Event Number
    27763
    Firm
    Ethicon Endo-Surgery
    FEI Number
    1527736
    Product Code
    LFL
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    November 25, 2003
    Posted
    December 17, 2003
    Terminated
    May 9, 2012
    Address
    4545 Creek Rd, Cincinnati, OH, 45242-2803

    Description

    FlexTray Procedure Delivery System Endopath Bariatric Surgery Tray, Product #FBW24.

    Reason

    A defective articulation band may result in improper staple formation with possible hematosis.

    Action

    The firm contacted their customers by FedEx on 11/25/2003. The product will be returned and destroyed.

    Distribution

    The product was shipped to hospitals and distributors located nationwide and worldwide.

    Quantity

    411