Device recall
Z-1969-2021: Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2…
FDA device recall · Class II · Spes Medica
Key facts
| Recall number (Z-number) | Z-1969-2021 |
|---|---|
| Recall event | 87999 |
| Product | Dragonfly Laryngeal Surface Electrode, ET Tube Size (mm): 6.0-7.5, Channel 2, Reference Number LSE3463DCA200 and LSE500DCS-5. for continuous EMG monitoring of the larynx during surgical procedures. |
| Product code | ETN |
| Recalling firm | Spes Medica |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 10, 2022 |
| 510(k) numbers | K093373 |
| FEI number | 3011534533 |
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