BEUDAMED
    FDA Recall Terminated

    smiths medical portex First Breath Adult Nasal Cannula, REF 001285, 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-0072-2019 · Initiated July 6, 2018

    Recall

    Recall Number
    Z-0072-2019
    Event Number
    80635
    Firm
    Smiths Medical ASD Inc.
    FEI Number
    3012307300
    Product Code
    CAT
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    July 6, 2018
    Terminated
    April 30, 2019
    Address
    6000 Nathan Ln N, Minneapolis, MN, 55442-1690

    Description

    smiths medical portex First Breath Adult Nasal Cannula, REF 001285, 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.

    Action

    The recalling firm issued an Urgent Medical Device Recall letters dated July 6, 2018 via UPS tracked hard-copy mailing The letter identified the affected product, problem and actions to be taken. Customers were requested to return affected products using the enclosed shipping label. For questions email Stericycle at [email protected].

    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

    2,550 devices