Device recall
Z-0407-2018: PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S
FDA device recall · Class II · Inovo, Inc
Key facts
| Recall number (Z-number) | Z-0407-2018 |
|---|---|
| Recall event | 78883 |
| Product | PURE OXYGEN CONCENTRATOR, CHAD Drive, Models CH5000 and CH5000S |
| Product code | CAW |
| Recalling firm | Inovo, Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Sep 15, 2023 |
| 510(k) numbers | K080391 |
| FEI number | 3000719543 |
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