BEUDAMED
    FDA Recall Terminated

    Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    Recall: Z-0946-05 · Initiated June 8, 2005

    Recall

    Recall Number
    Z-0946-05
    Event Number
    32167
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    LLD
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 8, 2005
    Posted
    June 30, 2005
    Terminated
    February 15, 2007
    Address
    1 Boston Scientific Pl, Natick, MA, 01760-1536

    Description

    Vaxcel Plastic Low Profile (non-valved) chest port, with 8Fr Polyurethane Catheter, Catalog # 45-338, Material #M001453380. Firm on label: Boston Scientific *** Manufactured at: 10 Glens Falls Technical Park, Glens Falls, NY 12801.

    Reason

    Potential for port housing separation after implantation.

    Action

    A recall package issued to direct accounts on 6/8/05. Hospitals are instructed to return product in inventory, notify physicians, evaluate patients and explant devices whenever possible.

    Distribution

    Product shipped to 56 medical facilities throughout the U.S.