BEUDAMED
    FDA Enforcement Class II Terminated

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    Recall: Z-2148-2019 · Reported August 14, 2019

    Enforcement

    Recall Number
    Z-2148-2019
    Event ID
    82519
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Olympus Corporation of the Americas
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 14, 2019
    Initiation Date
    April 1, 2019
    Classification Date
    August 2, 2019
    Termination Date
    June 9, 2020
    Address
    3500 Corporate Pkwy, PO Box 610, Center Valley, PA, 18034-0610, United States

    Description

    Olympus MAJ-209 Single Use Suction Valves, Model Number MAJ-209 Product Usage: This product has been designed to be attached to the suction cylinder of compatible endoscopes for aspirating fluid from the distal end of the endoscopes through the instrument channel. Compatible endoscopes include Olympus bronchoscopes, cystoscopes, rhino-laryngoscopes and pleurascopes models.

    Reason

    There is a potential for the single use suction valve to come apart and/or remain stuck inside the endoscope.

    Code Info

    Lot numbers: 88H, 89H, 8XH, 8YH, 8ZH, 91H

    Distribution

    The products were distributed US Nationwide.

    Quantity

    310000