FDA-Device2025-10-22Class II
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Hazard
When unintentionally disconnected from power source, humidifier device (used to deliver high flow warmed and humidified respiratory gases) may sound audible alert for less than 120 seconds, which may delay user awareness to reconnect power, which could lead to oxygen desaturation, hypoxia. Disinfection kit user manual updated to include checking the audible alert prior to use on a new patient.
Sold states
US Nationwide distribution including in the states of TX, MS, LA, NC, TN, NY, FL, IL, UT, MT, OH, MI, NJ, AR, GA, WI, CA, IN, OK, CO, AL, SC, AZ, MD, WA, MO, PA, MA, NH, KY, KS, VA, CT, MN, ND, NM, NE, IA, WV, ID, NV, OR, HI, VT, RI, AL, SD, WY, PR, ME.
Affected count
51,144
Manufactured in
15 Maurice Paykel Place, East Tamaki, Auckland, New Zealand
Products
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0158-2026Want us to check the next one for you?
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