BEUDAMED
    FDA Recall 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 · Initiated September 21, 2015

    Recall

    Recall Number
    Z-0195-2016
    Event Number
    72363
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    LRO
    Status
    Terminated
    Root Cause
    Mixed-up of materials/components
    Initiated
    September 21, 2015
    Posted
    October 30, 2015
    Terminated
    March 24, 2016
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    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.

    Action

    The recalling firm notified the consignee on 9/21/15 via phone call, and with a follow up visit to the consignee site. The recalled units were recovered.

    Distribution

    Distributed in VT.

    Quantity

    5 units