BEUDAMED
    FDA Enforcement Class II Terminated

    Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    Recall: Z-2730-2020 · Reported August 5, 2020

    Enforcement

    Recall Number
    Z-2730-2020
    Event ID
    85996
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    TELEFLEX MEDICAL INC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    August 5, 2020
    Initiation Date
    July 6, 2020
    Classification Date
    July 28, 2020
    Termination Date
    August 31, 2023
    Address
    3015 Carrington Mill Blvd, N/A, Morrisville, NC, 27560-5437, United States

    Description

    Rusch Greenlite Product Code: 004551003 GTIN: 14026704663122 (each) - Product Usage: The laryngoscope is a device intended to allow direct visualization of the laryngeal structure and is used during tracheal intubation.

    Reason

    Breaking at the point of a welded joint

    Code Info

    Lot/Batch Numbers: 1812331 1901331 1903331 1905331 1906331 1907331 1908331 1909331

    Distribution

    US Nationwide distribution including in the states of FL, KY, CA, ND, UT, MA, MD, AZ, MS, TX, MI, WV, AL, MO, SC, VA, AR, PA, OK, NV, NM, NE, IN, IA, NY, GA, NJ, MN, IL, NC, NH, TN, ID, CO, HI, MT, OR, ME, CT, LA, OH, RI, SD, WA, DC, KS, AK.

    Quantity

    301085 units