BEUDAMED
    FDA Recall Terminated

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

    Recall: Z-2401-2021 · Initiated August 4, 2021

    Recall

    Recall Number
    Z-2401-2021
    Event Number
    88425
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    OGK
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 4, 2021
    Terminated
    March 11, 2025
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    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.

    Action

    The letter dated 8/4/2021 was issued 8/4/2021 via tracked mail and requested return of the product.

    Distribution

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

    Quantity

    1,590 units