BEUDAMED
    FDA Enforcement Class II Terminated

    BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.

    Recall: Z-3238-2017 · Reported October 11, 2017

    Enforcement

    Recall Number
    Z-3238-2017
    Event ID
    77958
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Bomimed
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 11, 2017
    Initiation Date
    July 13, 2017
    Classification Date
    September 29, 2017
    Termination Date
    April 1, 2021
    Address
    1-100 Irene St, N/A, Winnipeg, N/A, N/A, Canada

    Description

    BOMImed Disposable Fiber Optic Medium Laryngoscope Handle. Each handle is packaged in an individual peel pouch, 20 handles per box. The rigid laryngoscope handle is a device used along with a blade to examine and visualize a patient's airway and aid placement of a tracheal tube.

    Reason

    Potential for intermittent lighting (flickering) during use.

    Code Info

    Part number: OL-334L6 Lot#: 2216, 3016, 4016 and 4816

    Distribution

    IL. PA. and WA CANADA

    Quantity

    680 (US) 2,220 (OUS)