Device recall
Z-2611-2023: TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for…
FDA device recall · Class II · Tytek Medical Inc
Key facts
| Recall number (Z-number) | Z-2611-2023 |
|---|---|
| Recall event | 92899 |
| Product | TyTek Tension Pneumothorax Access Kit TPAK10: 10 gauge, 3.25 inch- Intended for introduction into the body to facilitate removal of air from the pleural cavity in patients with a tension pneumothorax Model Number: TM-310 |
| Product code | GAA |
| Recalling firm | Tytek Medical Inc |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2026 |
| FEI number | 3004551550 |
At a glance
- None 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