BEUDAMED
    FDA Recall 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 · Initiated February 11, 2013

    Recall

    Recall Number
    Z-1063-2013
    Event Number
    64420
    FEI Number
    1219930
    Product Code
    GDW
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    February 11, 2013
    Posted
    April 5, 2013
    Terminated
    March 20, 2014
    Address
    LP 60 Middletown Ave, Covidien, North Haven, CT, 06473-3908

    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

    Action

    Covidien notified customers with an Urgent Medical Device Recall notification on February 11, 2013. The letter identified the affected product and the reason for the recall. Accounts were requested to quarantine and discontinue use of the affected devices, and notify Universal Loading Unit 30mm-2.0mm users of this recall. Customers should follow the instructions provided in order to return the affected product. Customers are to complete and return the Product Return Form regardless if they have any affected product or not. For questions regarding the RGA I return process, please contact Covidien Customer Service, M-F, 8 am - 6:30 pm ET at (800) 962-9888, option 1, and then option 2.

    Distribution

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

    Quantity

    6,751 units