Device recall
Z-2435-2010: The Provent Nasal Cannula is a nasal appliance device placed in both nostrils…
FDA device recall · Class III · Ventus Medical, Inc.
Key facts
| Recall number (Z-number) | Z-2435-2010 |
|---|---|
| Recall event | 54668 |
| Product | The Provent Nasal Cannula is a nasal appliance device placed in both nostrils intended to be used for transmission of respiratory airflow signals between the Provent Professional Sleep Apnea Therapy device and physiologic recorders. |
| Product code | MNR |
| Recalling firm | Ventus Medical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Mar 11, 2011 |
| 510(k) numbers | K080983 |
| FEI number | 3007038487 |
At a glance
- 1–9 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