FDA-Device2016-01-27Class II
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.
Valeant Pharmacueticals International
Hazard
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Sold states
USA (nationwide) Distribution and Internationally to Canada and France.
Affected count
1178
Manufactured in
400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0674-2016Don't want to check this manually?
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