BEUDAMED
    FDA Recall Terminated

    MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS 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-1936-2018 · Initiated April 24, 2018

    Recall

    Recall Number
    Z-1936-2018
    Event Number
    80017
    Firm
    Medline Industries Inc
    FEI Number
    1417592
    Product Code
    GAB
    Status
    Terminated
    Root Cause
    Package design/selection
    Initiated
    April 24, 2018
    Terminated
    August 4, 2020
    Address
    Three Lakes Drive, Northfield, IL, 60093

    Description

    MEDLINE O.R. Necessities(R) STERILE R, Needle Counter/Compte-aiguiles/Caja de agujas, Gold Standard/Standard Or/Oro y Estander, 40 Ct. Foam Block / Magnet with Blade Remover, Coussinet en mousse pour 40 aiguilles /Magnetise avec quitte-lame Or, 40 Ct Bloque de espuma / Iman Con extractor de hoja - Oro, REF NC40FBRGS 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.

    Action

    Medline sent an Urgent Recall letter dated April 24, 2018. The letter identified the affected product, problem and actions to be taken. Customer were instructed to check inventory, quarantine all affected product and return completed enclosed response form. Those consignees who further distributed the product were directed to notify their customers. For question contact 866-359-1704.

    Distribution

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

    Quantity

    2600 units