BEUDAMED
    FDA Enforcement Class II Ongoing

    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

    Recall: Z-0169-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0169-2024
    Event ID
    92895
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Covidien
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2023
    Initiation Date
    August 10, 2023
    Classification Date
    November 1, 2023
    Address
    6135 Gunbarrel Ave, N/A, Boulder, CO, 80301-3214, United States

    Description

    McGrath Mac 2, Disposable Laryngoscope Blade, REF: 350-084-000, Sterile EO, Rx Only

    Reason

    Laryngoscope blades may contain an ineffective application of anti-fog agent which may result in condensation accumulating causing the screen to be blurred or obscured.

    Code Info

    UDI: 10884521824386/ Lot # 22102001

    Distribution

    US: AK AL AR AZ CA CO CT DE FL GA IA IL IN KS LA MA MD MI MO MT NC ND NH NJ NM NY OH OK OR PA SD TN TX UT VA WA WI WY OUS: Australia Austria Azerbaijan Bahamas Belgium Croatia Czech Republic Denmark Finland France French Guiana Germany Guadeloupe Hong Kong Hungary Ireland Israel Italy Kazakhstan Korea, Republic Of Malta Mayotte Netherlands New Zealand Norway Pakistan Poland Portugal Reunion Romania Spain Sweden Switzerland Turkmenistan United Arab Emirates

    Quantity

    42,367