BEUDAMED
    FDA Enforcement Class II Ongoing

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    Recall: Z-1823-2024 · Reported May 22, 2024

    Enforcement

    Recall Number
    Z-1823-2024
    Event ID
    94398
    Classification
    Class II
    Status
    Ongoing
    Product Type
    Devices
    Firm
    Fisher & Paykel Healthcare, Ltd.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    May 22, 2024
    Initiation Date
    April 2, 2024
    Classification Date
    May 15, 2024
    Address
    15 Maurice Paykel Place, East Tamaki, Auckland, N/A, N/A, New Zealand

    Description

    Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US

    Reason

    Humidifier devices, used to deliver high flow respiratory therapy to patients, manufactured before 14 August 2017, have a speaker configuration that may result in distorted, intermittent or inaudible alarm sound levels. In the absence of an audible alarm, if there is an interruption to therapy, a patient may experience oxygen desaturation.

    Code Info

    REF/UDI-DI: PT100US/09420012422248, PT101US 09420012422347. Serial Number Range: 120521XXXXXX - 170813XXXXXX Note: X digits are variable and do not affect the identification of the affected range. Devices manufactured before 14 August 2017

    Distribution

    US Nationwide distribution including in the states of AK, AL, AR, AZ, CA, CO, CT, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, VT, WA, WI, WV, WY.

    Quantity

    7,147