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Fisher & Paykel Healthcare, Ltd. recalls Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Recalled May 22, 2024 · FDA recall Z-1823-2024 · Fisher & Paykel Healthcare
Hazard
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. · FDA Class II
Units
7,147
Sold at
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.
Description
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.
Product
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
Manufacturer(s)
Fisher & Paykel Healthcare, Ltd.
Made in
New Zealand
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →