BEUDAMED
    FDA Recall Terminated

    Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090

    Recall: Z-1039-03 · Initiated June 18, 2003

    Recall

    Recall Number
    Z-1039-03
    Event Number
    26621
    Firm
    Portex Inc.
    FEI Number
    1217052
    Product Code
    BTO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 18, 2003
    Posted
    July 23, 2003
    Terminated
    March 31, 2004
    Address
    10 Bowman Drive, Keene, NH, 03431

    Description

    Lo-Profile Fenestrated Tracheostomy Tube, Cuffed and Fenestrated Tube I.D. 9.0mm Catalog Number: 593090

    Reason

    Mislabeled:Tracheostomy tube was not fenestrated as specified on the label

    Action

    Portex notified four user facilities by telephone on June 18th and 19th, 2003 . The consignees were instructed to check their inventory for any affected product and to call to make arrangements for the return and credit of the affected product. If the product was in use, they were instructed to remove the fenestrated label on the inflation line and to inform the patient and healthcare provider of the discrepancy.

    Distribution

    CA, GA, KA, MO

    Quantity

    11 units