BEUDAMED
    FDA Enforcement Class II Terminated

    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.

    Recall: Z-1063-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1063-2013
    Event ID
    64420
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien LP
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    February 11, 2013
    Classification Date
    April 5, 2013
    Termination Date
    March 20, 2014
    Address
    60 Middletown Ave, North Haven, CT, 06473-3908, United States

    Description

    Covidien Endo GIA AutoSuture Universal Loading Unit, 30mm-2.0mm Product Code: 030450 Applications in abdominal, gynecologic, pediatric anti thoracic surgery for resection, transection and creation of anastomosis.

    Reason

    Single Use Loading Unit contained two staples loaded in each cartridge pocket and may result in difficulty firing and removing the device from the application site, which may require medical intervention

    Code Info

    Lot Codes: N2F0563LX, N2F0341LX, N2F0725LX, and N2E0605LX.

    Distribution

    Worldwide Distribution -- USA, Asia Pacific, Canada, Europe, and Japan.

    Quantity

    6,751 units