Device recall
Z-0371-2016: Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size…
FDA device recall · Class II · Valeant Pharmaceuticals North America LLC
Key facts
| Recall number (Z-number) | Z-0371-2016 |
|---|---|
| Recall event | 72198 |
| Product | Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole |
| Product code | CAF |
| Recalling firm | Valeant Pharmaceuticals North America LLC |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 27, 2017 |
| 510(k) numbers | K870051, K871427 |
| FEI number | 3010446985 |
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