Device recall
Z-0930-2020: PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for…
FDA device recall · Class I · Tytek Medical Inc
Key facts
| Recall number (Z-number) | Z-0930-2020 |
|---|---|
| Recall event | 84296 |
| Product | PneumoDart, 14 ga x 3.25in., REF TM-317 A compact, sterile, device intended for the introduction into the body to facilitate the removal of air from the pleural cavity as a result of a tension pneumothorax condition. |
| Product code | BWC |
| Recalling firm | Tytek Medical Inc |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Oct 1, 2020 |
| FEI number | 3004551550 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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