Device recall
Z-0805-2020: CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The…
FDA device recall · Class II · Caire, Inc.
Key facts
| Recall number (Z-number) | Z-0805-2020 |
|---|---|
| Recall event | 84512 |
| Product | CAIRE MODEL: FreeStyle Comfort Oxygen Concentrator - Product Usage: The FreeStyle Comfort Oxygen Concentrator is intended for the administration of supplemental oxygen. The device is not intended for life support nor does it provide any patient monitoring capabilities. |
| Product code | CAW |
| Recalling firm | Caire, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 20, 2020 |
| FEI number | 3004972304 |
At a glance
- None 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