BEUDAMED
    FDA Enforcement Class II Ongoing

    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

    Recall: Z-0205-2024 · Reported November 8, 2023

    Enforcement

    Recall Number
    Z-0205-2024
    Event ID
    92996
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    November 8, 2023
    Initiation Date
    August 22, 2023
    Classification Date
    October 31, 2023
    Address
    6000 Nathan Ln N, N/A, Minneapolis, MN, 55442-1690, United States

    Description

    Smiths Medical Portex Bivona Pediatric Tracheostomy Tube, Cuffless, Model 60P045, Sterile.

    Reason

    The unit box is labeled with an incorrect expiration date (the manufacturing date of 3/17/2021) but the individual packaging contains the correct expiration date (3/17/2026).

    Code Info

    Lot #4125816, exp. 3/17/2026, UDI-DI 15021312005769.

    Distribution

    Distribution was made to AZ, CA, FL, HI, IL, IN, MA, MN, MO, MS, NC, NJ, OH, PA, SC, TX, VA, and WA. There was no government/military distribution. Foreign distribution was made to Canada.

    Quantity

    N/A