BEUDAMED
    FDA Enforcement Class II Terminated

    LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.

    Recall: Z-1368-2015 · Reported April 8, 2015

    Enforcement

    Recall Number
    Z-1368-2015
    Event ID
    70633
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Quest Medical, Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 8, 2015
    Initiation Date
    February 26, 2015
    Classification Date
    April 2, 2015
    Termination Date
    February 26, 2016
    Address
    1 Allentown Pkwy, N/A, Allen, TX, 75002-4206, United States

    Description

    LIS27T - Lacrimal Intubation Set RX Only Sterile Used in various ophthalmology procedures.

    Reason

    Expiration date incorrectly printed in Manufacturing Date field on both pouch and carton labels

    Code Info

    Lot 40905AQ and 40601C

    Distribution

    Worldwide Distribution: US (nationwide) including DC and the states of IL, KY, TX, CA, FL, MI, GA, MD, NH, OH, NY, UT, NJ, MO, TN, VA, NC, CO, MI, and PA, and the country of Ireland.

    Quantity

    106 units