Device recall
Z-0344-2018: Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with…
FDA device recall · Class I · Vyaire Medical
Key facts
| Recall number (Z-number) | Z-0344-2018 |
|---|---|
| Recall event | 78636 |
| Product | Infant AirLife Dual-,limb, dual-heat, high-flow circuit (Model AH265) with AirLife Humidification Chamber, Model Number AH290. The AH290 Humidification Chamber and Heated Breathing Circuit Kit(s) operate as part of a system for delivering health and humidified respirator gasses to patients requiring… |
| Product code | BTT |
| Recalling firm | Vyaire Medical |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Feb 5, 2021 |
| 510(k) numbers | K160764 |
| FEI number | 2050001 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database