BEUDAMED
    FDA Enforcement Class II Terminated

    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

    Recall: Z-1934-2018 · Reported June 6, 2018

    Enforcement

    Recall Number
    Z-1934-2018
    Event ID
    80017
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medline Industries Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    June 6, 2018
    Initiation Date
    April 24, 2018
    Classification Date
    May 25, 2018
    Termination Date
    August 4, 2020
    Address
    Three Lakes Drive, N/A, Northfield, IL, 60093, United States

    Description

    MEDLINE O.R. Necessities(TM) Sterile* Needle Counter, 100 Ct. Double Magnet / Foam Block with Blade Remover, reorder: NC100FBR Product Usage: A needle counter is intended to be used safely and easily accounting for used, disposable surgical sharps during a surgical procedure. The product does not come in contact with the surgical site or the patient.

    Reason

    The product packaging seal has the potential to experience seal creep. This may result in gaps to be created in the seals of the packaging and may impact the sterility of the Needle Counters.

    Code Info

    Lot Numbers: 67016114502 67016124501 67016124502 67016124507 67017014501 67017024502 67017034501 67017034503 67017064502 67017074502 67017084502 67017084503 67017094501 67017094503 67017094505 67017104501 67017114501 67017114502

    Distribution

    Worldwide Distribution - US Nationwide and the countries of: Canada, Saudi Arabia, Cayman Island, and United Arab Emirates

    Quantity

    80200 units