BEUDAMED
    FDA Enforcement Class II Ongoing

    MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument

    Recall: Z-0117-2024 · Reported October 25, 2023

    Enforcement

    Recall Number
    Z-0117-2024
    Event ID
    92920
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    MEDLINE INDUSTRIES, LP - Northfield
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    October 25, 2023
    Initiation Date
    August 3, 2023
    Classification Date
    October 16, 2023
    Address
    3 Lakes Dr, N/A, Northfield, IL, 60093-2753, United States

    Description

    MEDLINE ReNewal Ligasure Blunt Tip Sealer/Divider Nano-Coated Compatible with FT10 Generator, REF LF1844CR. electrosurgical instrument

    Reason

    Various reprocessed Covidien LigaSure and Ethicon Harmonic devices may have an incomplete seal on the packaging tray.

    Code Info

    UDI/DI 10888277680418 (each), 20888277680415 (case), Lot Numbers: 498004

    Distribution

    US

    Quantity

    11 units