BEUDAMED
    FDA Recall Terminated

    Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.

    Recall: Z-1036-04 · Initiated June 18, 2004

    Recall

    Recall Number
    Z-1036-04
    Event Number
    29375
    Firm
    Advance Medical Designs Inc
    FEI Number
    1037885
    Product Code
    JAA
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2004
    Posted
    July 20, 2004
    Terminated
    September 3, 2004
    Address
    1241 Atlanta Industrial Dr, Marietta, GA, 30066-6606

    Description

    Advance Medical''s, The Closed Camera System, 9'' x 96'' (23cm x 244cm), REF 04-CC900, Lot 40475C4144, Sterile, Manufactured by Advance Medical Designs, Inc., 1241 Atlanta Industrial Drive, Marietta, GA 80066 USA.

    Reason

    The product may come apart when excessive force is applied to the coupler.

    Action

    Consignees were notified on 6/17/2004 first by telephone on 6/17/2004 with f/u letter sent 6/18/04.

    Distribution

    Nationwide and Canada

    Quantity

    2340 units, *amended to include additional 250 units