Recall Z-0158-2026 ยท BTT Humidifier, Respiratory Gas, (Direct Patient Interface)
Fisher & Paykel Healthcare, Ltd.
Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
| Date | Oct 15, 2025 (initiated Sep 18, 2025) |
| Status | Open, Classified |
| Reason | 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. |
| Root cause | Nonconforming Material/Component |
| Action | On 9/18/2025, correction notices were communicated via email and phone call. Customers were asked to do the following: 1) Prior to use on a new patient, follow the instructions of the updated Disinfection Kit User Manual. 2) If you have distributed affected devices, notify your customers and include a copy of this notice. 3) Please report all device-related incidents to the firm, distributor or local representative. 3) Complete and return the response form via email to FieldActionUSCA@fphcare.com The Disinfection Kit User Manual updated to include: 7a: Perform Power-Out Alarm test Ensure |
| Quantity | 51,144 |
| Distribution | 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. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K131895 | AIRVO 2 HUMIDIFIER, MYAIRVO 2 HUMIDIFIER Fisher & Paykel Healthcare, Ltd., Oct 24, 2013 |