BEUDAMED
    FDA Enforcement Class II Terminated

    BF-N20 OES Bronchofiberscope, Model No. BF-N20

    Recall: Z-2564-2021 · Reported October 6, 2021

    Enforcement

    Recall Number
    Z-2564-2021
    Event ID
    88562
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 6, 2021
    Initiation Date
    August 16, 2021
    Classification Date
    September 24, 2021
    Termination Date
    March 11, 2024
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    BF-N20 OES Bronchofiberscope, Model No. BF-N20

    Reason

    The firm is issuing validated, new reprocessing instructions according to the FDA 2015 guidance, "Reprocessing Medical Devices in Health Care Settings: Validation Methods and Labeling."

    Code Info

    All serial numbers

    Distribution

    Domestic distribution nationwide. Product also distributed globally.

    Quantity

    377