BEUDAMED
    FDA Enforcement Class I Terminated

    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿

    Recall: Z-0714-2019 · Reported February 13, 2019

    Enforcement

    Recall Number
    Z-0714-2019
    Event ID
    81021
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Medex Cardio-Pulmonary Inc., d.b.a. Smiths Medical Company
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 13, 2019
    Initiation Date
    September 5, 2017
    Classification Date
    February 4, 2019
    Termination Date
    April 16, 2024
    Address
    330 Corporate Woods Pkwy, Vernon Hills, IL, 60061-3107, United States

    Description

    Intermed 350 ml Sterile Water Humidifier w/5psi Adapt.¿¿¿¿ ¿¿¿ ¿¿¿

    Reason

    Lack of sterility assurance: leaking containers which could lead to exposure to infectious agents.

    Code Info

    Model # 0352IMJ Lot Numbers: ¿A457, A597, B157, B236, Z589, Z655, Z656, and Z661

    Distribution

    Worldwide distribution: US (nationwide) to states of: AZ, CA, CO, FL, GA, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, NC, NE, NH, NJ, NV, NY, OH, OR, PA, SC, TN, TX, UT, VA, VT, WA, WI, including PR; and countries of: Austria, Canada, Czech Republic, Chile, Cyprus, Ecuador, Estonia, Germany, Greece, Italy, Japan, and Switzerland.

    Quantity

    128,000 sold to Japan only