Humidifier devices recalled because power loss alert sounds under two minutes
Fisher & Paykel is recalling 51,144 Airvo 2 and myAirvo 2 humidifiers because an unintentional power disconnection may sound an audible alert for less than 120 seconds.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a short alert after power loss could delay reconnection and lead to oxygen desaturation, and no injuries are reported.
Plain-English summary
Airvo 2 (REF PT101US) and myAirvo 2 (REF PT100US), used with the Disinfection Kit User Manual (REF UI-185043723), are being recalled. The devices deliver high flow warmed and humidified respiratory gases.
When unintentionally disconnected from the power source, the humidifier may sound an audible alert for less than 120 seconds. That may delay the user's awareness of the need to reconnect power, which could lead to oxygen desaturation and hypoxia. The disinfection kit user manual has been updated to include checking the audible alert before use on a new patient.
The recall covers 51,144 units carrying UDI-DIs 9420012422347 and 9420012422248, and all revisions of the disinfection kit user manual before the updated version. The product was distributed nationwide in the United States. The FDA has classified the action as Class II.
Clinical teams should follow the updated manual, including the pre-use alert check.
The recalled product
- Product
- Airvo 2, REF: PT101US, and myAirvo 2, REF: PT100US, used with Disinfection Kit User Manual, REF: UI-185043723
- Manufacturer
- Fisher & Paykel Healthcare, Ltd.
- Hazard
- alarm-duration
- power-loss
- hypoxia-risk
- labeling-update
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- REF/UDI-DI: PT101US/9420012422347
Distribution
Distributed nationwide across the United States.
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