Valeant Recalls SPAG-2 Nebulizers for Particle Size Failures
Valeant Pharmaceuticals is recalling 418 SPAG-2 units and 808 nebulizers because some units failed to meet particle size specifications for ribavirin aerosol administration.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, and the source text describes a failure to meet technical specifications without reporting any illnesses, injuries, or hospitalizations. This aligns with the rubric for moderate severity involving low-risk contamination or voluntary precautionary measures.
Plain-English summary
Valeant Pharmaceuticals International is recalling 418 Small Particle Aerosol Generator (SPAG-2) units and 808 nebulizers. These devices are pneumatic flow systems indicated for the administration of Virazole (ribavirin) aerosol. The affected units were distributed in the United States and Canada.
The recall was initiated after testing in November 2016 revealed that nebulizers from Lot J0571670RA failed to meet particle size specifications. Specifically, the devices delivered particle sizes that did not meet the required mean values for Dv10, Dv50, and Dv90. Cleaning the units according to approved procedures did not resolve the high droplet size distribution values observed in three of the four initially failing units.
Consumers and healthcare providers should stop using the affected SPAG-2 units and nebulizers. Affected units can be identified by specific lot and serial numbers, including Lot J0571670RA, J0571670R, J0571670, L0197340, and K1900650. Users should contact Valeant Pharmaceuticals for further instructions on returning or replacing the devices.
The recalled product
- Product
- 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 a
- Manufacturer
- Valeant Pharmacueticals International
- Category
- Medical Device — Nebulizer
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (5)
- 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.
Distribution
Distributed nationwide across the United States.
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