BEUDAMED
    FDA Recall Terminated

    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

    Recall: Z-1020-2019 · Initiated February 15, 2019

    Recall

    Recall Number
    Z-1020-2019
    Event Number
    82244
    Firm
    Covidien, PLC
    FEI Number
    1717344
    Product Code
    GEI
    Status
    Terminated
    Root Cause
    Equipment maintenance
    Initiated
    February 15, 2019
    Terminated
    June 17, 2020
    Address
    5920 Longbow Dr, Boulder, CO, 80301-3202

    Description

    Covidien Force TriVerse electrosurgical device 10 cord-Intended as electrosurgical energy to cut and/or coagulate tissue. Product Usage: Single-use device intended for use in open procedures (such as general, urologic, thoracic, plastic and reconstructive, gynecologic) and minimally invasive arthroscopic procedures where the surgeon desires monopolar radio-frequency electrosurgical energy to cut and/or coagulate tissue. The electrosurgical device is intended for use with conventional monopolar electrosurgical electrodes. Item Code: FT3000F

    Reason

    Potential for the sterile packaging to be compromised

    Action

    Medtronic notified via letter by Federal Express and/or certified mail on February 15, 2019. The letter informs customers of the recall of one production lot of Covidien Force TriVerse" electrosurgical devices 10 cord due to the potential for the sterile packaging to be compromised and the actions they should take. Through this notification customers are instructed to take the following actions: " Immediately quarantine and discontinue use of the affected item code and lot. " Return affected product. " Forward the information to anyone who they have distributed affected Covidien Force TriVerse" electrosurgical devices 10 cord. " Complete the Recalled Product Return Form

    Distribution

    US Nationwide Distribution

    Quantity

    850 units