BEUDAMED
    FDA Recall Terminated

    Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080

    Recall: Z-0714-06 · Initiated March 7, 2006

    Recall

    Recall Number
    Z-0714-06
    Event Number
    34762
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1217052
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    March 7, 2006
    Posted
    April 6, 2006
    Terminated
    May 8, 2012
    Address
    10 Bowman Dr, Keene, NH, 03431-5043

    Description

    Blue Line Ultra Tracheostomy Tube 8.00mm Inner Cannula REF 100/858/080

    Reason

    Mislabeled Product labeled as 8.0mm inner cannula, may contain a 9.0mm

    Action

    Smiths Medical ASD, Inc. notified US customers by letter dated 3/7/06. Accounts are requested to return inventory.

    Distribution

    Nationwide

    Quantity

    5350 units (107 cases)