BEUDAMED
    FDA Recall Terminated

    LigaSure Atlas Laparoscopic Vessel Sealer/Divider

    Recall: Z-0772-06 · Initiated January 27, 2006

    Recall

    Recall Number
    Z-0772-06
    Event Number
    34573
    Firm
    Covidien LP
    FEI Number
    1717344
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Other
    Initiated
    January 27, 2006
    Posted
    April 19, 2006
    Terminated
    August 15, 2008
    Address
    5920 Longbow Dr, Boulder, CO, 80301-3202

    Description

    LigaSure Atlas Laparoscopic Vessel Sealer/Divider

    Reason

    Sealing cycle may be interrupted during vessel ligation procedure, resulting in an incomplete seal.

    Action

    Consignees were notified by letter on 01/27/2006.

    Distribution

    Nationwide, including 52 VA facilities and 12 military facilities. Foreign distribution to Argentina, Australia, Brazil, Canada, Chile, Colombia, Costa Rica, Curacao, Germany, Guatamala, Israel, Japan, Mexico, Paraguay, Peru, Singapore, South Africa, Uruguay, Venezuela.

    Quantity

    124,000 units domestic, 126,000 units internationally.