Device recall
Z-0384-2018: Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2…
FDA device recall · Class II · Valeant Pharmacueticals International
Key facts
| Recall number (Z-number) | Z-0384-2018 |
|---|---|
| Recall event | 77289 |
| Product | Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated… |
| Product code | CAF |
| Recalling firm | Valeant Pharmacueticals International |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 18, 2019 |
| 510(k) numbers | 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