Device Recall SPAG2 unit nebulizers

  • Modelo / Serial
    Lot Number J0571670RA*/Serial Number 337170600007; Lot Number J0571670R*/Serial Number 337170600007; Lot Number J0571670/Serial Number 337170600007; Lot Number L0197340/Serial Number 340150600003; Lot Number K1900650/Serial Number 340150600003.
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    US Nationwide & Canada
  • Descripción del producto
    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 Virazole. || --- CDRH Classification Name: Nebulizer (Direct Patient Interface)
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Valeant Pharmacueticals International, 1400 Goodman St N, Rochester NY 14609-3547
  • Source
    USFDA