Device recall
Z-0497-2021: ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0…
FDA device recall · Class I · Flexicare Medical Ltd.
Key facts
| Recall number (Z-number) | Z-0497-2021 |
|---|---|
| Recall event | 86484 |
| Product | ProVu Single Use Video Stylet with ET Tube, Part/Size: 038-990-080U/ 8.0, 038-990-075U/ 7.5, 038-990-070U/ 7.0, 038-990-065U/ 6.5 *Note: product list updated per 12/23/2020 letter to customers |
| Product code | BTR |
| Recalling firm | Flexicare Medical Ltd. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Jul 29, 2024 |
| 510(k) numbers | K091591 |
| FEI number | 3006363476 |
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