BEUDAMED
    FDA Recall Terminated

    Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.

    Recall: Z-0954-2011 · Initiated December 8, 2010

    Recall

    Recall Number
    Z-0954-2011
    Event Number
    57498
    Firm
    Covidien LP
    FEI Number
    1717344
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    December 8, 2010
    Posted
    January 25, 2011
    Terminated
    March 27, 2012
    Address
    5920 Longbow Dr, Boulder, CO, 80301-3202

    Description

    Covidien, LigaSure, Blunt Tip Laparoscopic Sealer/Divider, 5 mm-37 cm, REF LF1537, Sterile EO, Covidien, Valleylab, a division of Tyco Healthcare Group LP, 5920 Longbow Drive, Boulder, CO 80301 Intended use: LigaSure 5 mm devices are electrosurgical instruments designed to permanently seal and divide vessels, tissue bundles, and lymphatics.

    Reason

    During surgical procedures, the device may energize when clamping without pushing the activation button, which could result in unintended energy delivery to tissue.

    Action

    The firm, Covidien, sent a "URGENT: PRODUCT RECALL" letter dated December 6, 2010, to the customers. The letter described the product, problem and the action to be taken by the customers. The customers were instructed to remove product from inventory, immediately quarantine the product and return any remaining stock of the lots listed to: Covidien Energy-based devices, Attention: R82, Building 4/Receiving, 5920 Longbow Drive, Boulder, CO 80301. The customers were also instructed to complete and return the Customer Response Form immediately via mail (in the envelope provided) or fax to (303) 516-8307. To return any identified product for credit or replacement, contact Customer Service at 1-800-722-8772 Option 1. Should you have any medical questions concerning this recall, please contact your local sales representative or the Covidien Clinical information Hotline at (800) 255-8522 (option 1).

    Distribution

    Worldwide distribution: USA and countries including: Australia, Canada, France, Germany, Japan, Puerto Rico, Singapore, and Uruguay.

    Quantity

    25,009 units