Device recall
Z-0935-2022: CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US
FDA device recall · Class II · Graphic Controls Acquisition Corporation
Key facts
| Recall number (Z-number) | Z-0935-2022 |
|---|---|
| Recall event | 89810 |
| Product | CLARAVUE Pre-wired Electrode IP-SET N3 - PEDIATRIC-US Model: 32028776 50401-US |
| Product code | DRX |
| Recalling firm | Graphic Controls Acquisition Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 12, 2024 |
| 510(k) numbers | K101685 |
| FEI number | 1317188 |
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