Devices

Device Recall SPAG2 unit nebulizers

Model / 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.
Product Classification
Anesthesiology Devices
Device Class
2
Implanted device?
No
Distribution
US Nationwide & Canada
Product Description
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
Valeant Pharmacueticals International
1 Event
- Recall of Device Recall SPAG2 unit nebulizers

Manufacturer

Valeant Pharmacueticals International

Manufacturer Address
Valeant Pharmacueticals International, 1400 Goodman St N, Rochester NY 14609-3547
Source
USFDA

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Medical devices help to diagnose, prevent and treat many injuries and diseases. We are not suggesting or implying that any companies or other entities included in the International Medical Devices Database engaged in unlawful conduct or otherwise acted improperly. The same device may have different names in different countries. This database is not intended to provide medical advice and patients should check with their doctors to determine if it contains relevant information and if such information has medical implications for them.

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