BEUDAMED
    FDA Recall Terminated

    Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S

    Recall: Z-0961-04 · Initiated May 5, 2004

    Recall

    Recall Number
    Z-0961-04
    Event Number
    28998
    Firm
    United States Surgical
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 5, 2004
    Posted
    July 20, 2004
    Terminated
    November 15, 2006
    Address
    195 Mcdermott Rd, North Haven, CT, 06473-3665

    Description

    Auto SutureTA 45 Reloadable Stapler,Single Patient Use, 3.5mm DST Series Ref: TA4535S

    Reason

    Stapler may clamp without the staples being fired into the tissue

    Action

    United States Surgical notiied direct accounts by letter dated 5/5/04. Accounts are requested to inventory and quarantine product for return to USS.

    Distribution

    Nationwide