BEUDAMED
    FDA Recall Terminated

    Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070

    Recall: Z-1016-04 · Initiated May 19, 2004

    Recall

    Recall Number
    Z-1016-04
    Event Number
    29136
    Firm
    Smiths Medical ASD, Inc Anesthesia and Safety Devices Division
    Product Code
    JOH
    Status
    Terminated
    Root Cause
    Other
    Initiated
    May 19, 2004
    Posted
    July 20, 2004
    Terminated
    May 2, 2006
    Address
    10 Bowman Drive, Keene, NH, 03431-0724

    Description

    Portex Inner Cannula for Tracheostomy Tube Size 7.0 mm, REF Code 566070

    Reason

    Incompatible products may cause potential trachea trauma

    Action

    Smiths Medical ASD notified the consignees by letter, dated 5/21/04. All responses to the notification are to be completed by fax and directed to Smiths Medical Regulatory Affairs Departement. The recalled products are to be returned and scrapped by Smiths Medical.

    Distribution

    Nationwide

    Quantity

    25,400