Device recall
Z-1033-2012: Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only…
FDA device recall · Class III · Ventus Medical, Inc.
Key facts
| Recall number (Z-number) | Z-1033-2012 |
|---|---|
| Recall event | 61129 |
| Product | Provent -SR - Sleep Apnea Therapy-SR (standard resistance). Prescription only, Single Use; Packed 30 units per box Manufactured in the USA by Ventus Medical Inc. 1301 Shoreway Road, Suite 425; Belmont, CA 94002 Used in the treatment of obstructive sleep apnea. |
| Product code | OHP |
| Recalling firm | Ventus Medical, Inc. |
| Recall class | Class III |
| Status | Terminated |
| Termination date | Feb 15, 2012 |
| 510(k) numbers | K090398 |
| 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