BEUDAMED
    FDA Enforcement Class II Terminated

    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

    Recall: Z-1732-2019 · Reported June 12, 2019

    Enforcement

    Recall Number
    Z-1732-2019
    Event ID
    82387
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    E-Mail
    Report Date
    June 12, 2019
    Initiation Date
    February 11, 2019
    Classification Date
    June 4, 2019
    Termination Date
    November 2, 2020
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    Portex Blue Line Ultra Tracheostomy Tube Inner Cannula. One cannula comes inside a package which is labeled in part, Product Usage: The Portex Blue Line Ultra¿ Tracheostomy Tubes are indicated for airway maintenance of tracheostomized patients.

    Reason

    Packaged with an incorrect size inner cannula.

    Code Info

    Item code/product number: 100/856/080 lot number: 3578884

    Distribution

    Worldwide Distribution - US Nationwide AL, CA, CT, FL, IL, KY, MA, MD, NC, NJ, OH, OR, PA, RI, SC, TN, UT, and VA. Canada, UK and Ireland

    Quantity

    7,840