BEUDAMED
    FDA Enforcement Class III Terminated

    smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    Recall: Z-0071-2019 · Reported October 10, 2018

    Enforcement

    Recall Number
    Z-0071-2019
    Event ID
    80635
    Classification
    Class III
    Status
    Terminated
    Product Type
    Devices
    Firm
    Smiths Medical ASD Inc.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 10, 2018
    Initiation Date
    July 6, 2018
    Classification Date
    October 4, 2018
    Termination Date
    April 30, 2019
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690, United States

    Description

    smiths medical portex First Breath Adult Nasal Cannula, REF 001283, Non-flared Tips, 213 cm (7 ft.) Tubing, Over-the-Ear Style. Product Usage: For the administration of nasal oxygen and humidity to patients.

    Reason

    "Manufactured" and "Use By" labels are transposed incorrectly suggesting the product expires before it was manufactured.

    Code Info

    Lot numbers 1703221A and 1705111A

    Distribution

    Worldwide Distribution - US Nationwide in the states of AR, CA, GA, IN, LA, OK, MA, MI, NC, NJ, NV, SC, TX, VA, and WV. There was government distribution and no military distribution. Foreign distribution was made to Poland and Russia.

    Quantity

    12,000 devices