Drug recall
Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US
FDA recall event 94398 · Class II · Fisher & Paykel Healthcare, Ltd.
Key facts
| Event ID | 94398 |
|---|---|
| Recall numbers | Z-1823-2024 |
| Recalling firm | Fisher & Paykel Healthcare, Ltd. |
| Product type | Devices |
| Products | Airvo 2 Humidifier, REF: PT101US, and myAirvo 2 Humidifier, REF: PT100US |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Firm Initiated |
| Reason for recall | 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… |
| Initiation date | Apr 2, 2024 |
| Report date | May 22, 2024 |
| City | Auckland |
| Country | New Zealand |
| FEI number | 3002806988 |
At a glance
- 1–9 Products in this recall
- 1–9 FDA inspections of this firm (FEI)
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA drug and product recalls
FDA enforcement reports list recalls of drugs, biologics, foods and other FDA-regulated products, classified by the potential health hazard.
Source: U.S. Food and Drug Administration (FDA), Enforcement Reports · Source date: