BEUDAMED
    FDA Recall Terminated

    GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079

    Recall: Z-2502-2010 · Initiated January 22, 2010

    Recall

    Recall Number
    Z-2502-2010
    Event Number
    56418
    Firm
    AMS Innovative Center San Jose
    FEI Number
    2937094
    Product Code
    GEX
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    January 22, 2010
    Posted
    September 25, 2010
    Terminated
    January 25, 2011
    Address
    3070 Orchard Dr, San Jose, CA, 95134-2011

    Description

    GreenLight HPS fiber optics, Model Number 10-2090, manufactured by AMS (American Medical Systems), San Jose, CA. Potentially Mislabeled as GreenLight PV 10-2079

    Reason

    Product may be packed with incorrect external or internal labels and/or missing product insert.

    Action

    Notification issued via letter with instructions and response sheet through certified mail on 01/12/2010.

    Distribution

    Product was distributed to 148 medical facilities throughout the US. and 6 consignees in Great Britain, Canada and Australia.

    Quantity

    11668 units