BEUDAMED
    FDA Enforcement Class II Terminated

    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

    Recall: Z-0705-2018 · Reported March 7, 2018

    Enforcement

    Recall Number
    Z-0705-2018
    Event ID
    78929
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Teleflex Medical
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    March 7, 2018
    Initiation Date
    January 10, 2017
    Classification Date
    February 23, 2018
    Termination Date
    April 13, 2021
    Address
    2917 Weck Dr, N/A, Research Triangle Park, NC, 27709-0186, United States

    Description

    Rusch Greenlite MAC 1, Catalog Number 004551001. Used during tracheal intubation.

    Reason

    The pouch may contain the incorrect Rusch Green Lite product size. Pouches that are labeled as containing RUSCH GREEN LITE MAC 1 may instead contain RUSCH GREEN LITE MAC 2.

    Code Info

    Lot/Serial number: 1602312

    Distribution

    US only

    Quantity

    2140 units