BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-1368-2015 · Initiated February 26, 2015

    Recall

    Recall Number
    Z-1368-2015
    Event Number
    70633
    Firm
    Quest Medical, Inc.
    FEI Number
    3001665800
    Product Code
    HNL
    Status
    Terminated
    Root Cause
    Labeling Change Control
    Initiated
    February 26, 2015
    Posted
    April 2, 2015
    Terminated
    February 26, 2016
    Address
    1 Allentown Pkwy, Allen, TX, 75002-4206

    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

    Action

    The consignees were notified by letter on 3/2/2015. The recalling firm requested the consignees to return the recalled product for a replacement device.

    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