BEUDAMED
    FDA Recall Open, Classified

    MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument

    Recall: Z-0118-2024 · Initiated August 3, 2023

    Recall

    Recall Number
    Z-0118-2024
    Event Number
    92920
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    NUJ
    Status
    Open, Classified
    Root Cause
    Packaging
    Initiated
    August 3, 2023
    Posted
    October 16, 2023
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    MEDLINE ReNewal Ligasure Maryland Jaw Sealer/Divider Nano-Coated Complatible with FT10 Generator, REF LF1944CR. electrosurgical instrument

    Reason

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

    Action

    Medline issued a recall notice to its consignees by email on 08/03/2023. The notice explained the problem and the potential risk. Those consignees who have transferred possession of the affected product were directed to notify their customers. The firm is seeking the return of the affected product. An error in the model number was noted (missing an "R" at the end) and the firm issued an updated letter on 09/19/2023 with the corrected number.

    Distribution

    US

    Quantity

    58 units