BEUDAMED
    FDA Enforcement Class II Terminated

    Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System

    Recall: Z-1116-2020 · Reported February 19, 2020

    Enforcement

    Recall Number
    Z-1116-2020
    Event ID
    84702
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TELEFLEX MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 19, 2020
    Initiation Date
    January 9, 2020
    Classification Date
    February 7, 2020
    Termination Date
    September 11, 2023
    Address
    3015 Carrington Mill Blvd, Morrisville, NC, 27560-5437, United States

    Description

    Rusch Greenlite Single-Use Metal Laryngoscope Blade for Fiber Optic System

    Reason

    The products are being recalled due to reports of breakage broke at the point of a welded joint either prior to use during setup or during use inside the patient's mouth.

    Code Info

    Product Code 004551003; Lot Numbers 1811331, 1902331, 1904331

    Distribution

    Distributed nationwide in the US and to Puerto Rico; OUS to more than 20 countries; To the following government VA medical Centers: VAMC - KANSAS CITY MO 4801 E Linwood Blvd Kansas City MO 64128-2218

    Quantity

    338,928 (199,018 US and 139,910 OUS) for all products