BEUDAMED
    FDA Enforcement Class II 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 · Reported March 27, 2019

    Enforcement

    Recall Number
    Z-1020-2019
    Event ID
    82244
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Covidien, PLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 27, 2019
    Initiation Date
    February 15, 2019
    Classification Date
    March 18, 2019
    Termination Date
    June 17, 2020
    Address
    5920 Longbow Dr, N/A, Boulder, CO, 80301-3202, United States

    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

    Code Info

    Lot Number: 80390309X UDI-Device Identifier (GTIN/UPN) 10884524000084/ 20884524000081

    Distribution

    US Nationwide Distribution

    Quantity

    850 units