BEUDAMED
    FDA Recall Open, Classified

    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.

    Recall: Z-3095-2024 · Initiated May 7, 2024

    Recall

    Recall Number
    Z-3095-2024
    Event Number
    95126
    Firm
    MEDLINE INDUSTRIES, LP Northfield
    FEI Number
    1417592
    Product Code
    NLQ
    Status
    Open, Classified
    Root Cause
    Under Investigation by firm
    Initiated
    May 7, 2024
    Posted
    September 10, 2024
    Address
    3 Lakes Dr, Northfield, IL, 60093-2753

    Description

    Medline ReNewal Reprocessed Ethicon Harmonic ACE+7 Shears w/ Adv. Hemostasis Use Only w/GEN11 SW v2018-1 and Lower 5mm x 36cm. Item Number: HARH36R.

    Reason

    Potential for an incomplete seal on the packaging tray.

    Action

    Medline notified consignees on about 05/06/2024 via letter sent email or First-Class mail. Consignees were instructed to examine inventory and quarantine any affected units, return any affected product that they may have on hand for credit or replacement, notify customers or personnel if the affected product was further distributed or transferred, and complete and return the response form.

    Distribution

    US Nationwide distribution.

    Quantity

    46 units