BEUDAMED
    FDA Recall Terminated

    EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.

    Recall: Z-2236-2008 · Initiated June 17, 2008

    Recall

    Recall Number
    Z-2236-2008
    Event Number
    48698
    Firm
    Boston Scientific Corporation One Boston
    FEI Number
    3001451463
    Product Code
    KNT
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    June 17, 2008
    Posted
    September 17, 2008
    Terminated
    December 10, 2008
    Address
    Scientific Place Natick, MA, 01760

    Description

    EndoVive Safety PEG Kits 24 F Universal Product Number (UPN): MOO56648 1 The product provides nutrition directly into the stomach of adult and pediatric patients who are unable to consume by conventional methods.

    Reason

    Mislabeled: Inner box labeled 20 Fr PEG, outer and tray label correctly labeled 24 Fr PEG

    Action

    Boston Scientific notified customers by priority Express Mail on June 17, 2008. The notification instructs accounts to check their inventory, remove any affected product from their inventory, and return it to Boston Scientific. The notification also requests the completion of a Reply Verification Tracking Form as a method of documenting the presence or absence of affected product from their inventory. Contact Boston Scientific Corporation at 1-800-272-3737 for assistance.

    Distribution

    NJ, SC, TN, VA, and WI

    Quantity

    16 Kits (total number of Kits)