BEUDAMED
    FDA Enforcement Class II Terminated

    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

    Recall: Z-0195-2016 · Reported November 11, 2015

    Enforcement

    Recall Number
    Z-0195-2016
    Event ID
    72363
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Alcon Research, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Telephone
    Report Date
    November 11, 2015
    Initiation Date
    September 21, 2015
    Classification Date
    October 30, 2015
    Termination Date
    March 24, 2016
    Address
    6201 South Fwy, N/A, Fort Worth, TX, 76134-2099, United States

    Description

    Custom Pak 9319-27. Single-use medical devices and accessories designed by medical professionals for a specific ophthalmic surgical procedure.

    Reason

    The recalled lot of custom paks are labeled as latex free and contain latex gloves rather than the specified non-latex gloves.

    Code Info

    1792733H, 1783925H, 1785227H, 1786729H

    Distribution

    Distributed in VT.

    Quantity

    5 units