FDA-Device2015-12-16Class II
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
Valeant Pharmaceuticals North America LLC
Hazard
SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
Sold states
AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX
Affected count
61 units
Manufactured in
400 Somerset Corporate Blvd, N/A, Bridgewater, NJ, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0371-2016Don't want to check this manually?
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