Device recall
Z-0674-2016: Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator…
FDA device recall · Class II · Valeant Pharmacueticals International
Key facts
| Recall number (Z-number) | Z-0674-2016 |
|---|---|
| Recall event | 72630 |
| Product | Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol. |
| Product code | CAF |
| Recalling firm | Valeant Pharmacueticals International |
| Recall class | Class II |
| Status | Terminated |
| Termination date | May 19, 2017 |
| 510(k) numbers | K870051, K871427 |
| FEI number | 3009443653 |
At a glance
- 1–9 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