Device recall
Z-2908-2020: Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI…
FDA device recall · Class II · Neurovision Medical Products Inc
Key facts
| Recall number (Z-number) | Z-2908-2020 |
|---|---|
| Recall event | 86102 |
| Product | Cobra x5 2-Ch EMG ET Tube, 8.0mm, REF: LTE700DCL-5, Rx Only, Sterile EO UDI: B006LTE700DCL52 - Product Usage: For continuous EMG monitoring and status assessment of the nerves supplying the laryngeal musculature as well as providing an open airway for patient ventilation during surgical or… |
| Product code | ETN |
| Recalling firm | Neurovision Medical Products Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 30, 2021 |
| 510(k) numbers | K110989 |
| FEI number | 1930870 |
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