BEUDAMED
    FDA Recall Terminated

    Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.

    Recall: Z-0301-06 · Initiated July 25, 2005

    Recall

    Recall Number
    Z-0301-06
    Event Number
    32915
    Firm
    Smiths Medical ASD, Inc.
    FEI Number
    1824231
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    July 25, 2005
    Posted
    December 23, 2005
    Terminated
    December 4, 2007
    Address
    5700 W 23rd Ave, Gary, IN, 46406-2617

    Description

    Bivona brand TTS Adjustable Neck Flange Hyperflex Tracheostomy Tubes, sterile, Product 67HA70.

    Reason

    Instructions for use included in the package are for a different tracheostomy tube.

    Action

    Consignees were notified via 'precautionary product advisory notification' letter dated July 25, 2005.

    Distribution

    Nationwide.

    Quantity

    91