BEUDAMED
    FDA Recall Terminated

    ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250

    Recall: Z-1061-03 · Initiated July 3, 2003

    Recall

    Recall Number
    Z-1061-03
    Event Number
    26713
    Firm
    Boston Scientific Corporation
    FEI Number
    3001451463
    Product Code
    KNW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 3, 2003
    Posted
    July 29, 2003
    Terminated
    June 17, 2004
    Address
    1 Boston Scientific Place, Natick, MA, 01760

    Description

    ASAP Channel Cut Biopsy System, 14 gauge Reference Number: 1250

    Reason

    Sterility of the device may be compromised due to a lack of package integrity

    Action

    Boston Scientific notified accounts by letter on 7/3/03. Accounts are requested to check inventory and return product. A Veification Form was requested to be completed.

    Distribution

    Nationwide

    Quantity

    1,030 units