BEUDAMED
    FDA Enforcement Class II Terminated

    smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

    Recall: Z-2401-2021 · Reported September 8, 2021

    Enforcement

    Recall Number
    Z-2401-2021
    Event ID
    88425
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 8, 2021
    Initiation Date
    August 4, 2021
    Classification Date
    September 1, 2021
    Termination Date
    March 11, 2025
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical portex Tracheal Intubation Stylet, REF 100/120/200, 4.0mm OD X 335mm, 10/box, sterile.

    Reason

    The incorrect device is contained in the package.

    Code Info

    Lot 4015424

    Distribution

    International distribution was made to the countries of Canada, Japan, Indonesia, and Spain.

    Quantity

    1,590 units