BEUDAMED
    FDA Recall Terminated

    CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks

    Recall: Z-1940-2016 · Initiated April 28, 2016

    Recall

    Recall Number
    Z-1940-2016
    Event Number
    73998
    Firm
    Alcon Research, Ltd.
    FEI Number
    1610287
    Product Code
    HQC
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    April 28, 2016
    Posted
    June 9, 2016
    Terminated
    March 31, 2017
    Address
    6201 South Fwy Fort, Worth, TX, 76134-2099

    Description

    CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks

    Reason

    Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.

    Action

    The affected consignees were sent a recall notification letter on 4/28/16.

    Distribution

    US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay

    Quantity

    156,712 units