Device recall
Z-1011-2023: Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal…
FDA device recall · Class II · TELEFLEX LLC
Key facts
| Recall number (Z-number) | Z-1011-2023 |
|---|---|
| Recall event | 91301 |
| Product | Endotracheal Tube labeled as the following: a. Flexi-Set Cuffed Endotracheal Tube and Stylet Set, oral/nasal; b. Endotracheal Tube oral/nasal Murphy Eye, High Volume, Low Pressure Cuff; c. RUSCHELIT Super Safety Clear Tracheal Tube, oral/nasal, Murphy. Intended for patients requiring endotracheal… |
| Product code | BTR |
| Recalling firm | TELEFLEX LLC |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K961837 |
| FEI number | 3005747797 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 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