Device 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.
Z-0674-2016
Product summary
- Event
- Event 72630
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1178
- Official record key
device-enforcement:Z-0674-2016
Official wording
Reason: The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Code information: SPAG 2 Unit, Product Part Number 6002
Distribution pattern: USA (nationwide) Distribution and Internationally to Canada and France.
Derived failure modes
-
Unknown
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.