Valeant SPAG-2 Nebulizer Recalled for Incorrect Serial Labels and Manual Information
Valeant is recalling 1,178 SPAG-2 nebulizer units because serial ID labels and operation manuals contain incorrect or outdated information.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for documentation and labeling errors (incorrect serial labels and outdated manual information) without any reported injuries or health hazards, fitting the 'Low' severity criteria for documentation issues.
Plain-English summary
Valeant Pharmaceuticals International is recalling 1,178 units of the Small Particle Size Aerosol Generator (SPAG-2) 6000 series. The recall is due to incorrect or outdated information on the Serial I.D. Label and in the Operation Manual, which includes references to accessories that are no longer available.
The affected product is a nebulizer pneumatic flow system used for the administration of Virazole (ribavirin) aerosol. The units were distributed nationwide in the United States and internationally to Canada and France. The specific product part number is 6002.
Consumers should contact Valeant Pharmaceuticals International for further instructions regarding the recall. The source text does not specify a particular action for consumers other than the recall itself.
The recalled product
- Product
- 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.
- Manufacturer
- Valeant Pharmacueticals International
- Category
- Medical Device — Nebulizer
- Affected units
- 1,178
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 (2)
- SPAG 2 Unit
- Product Part Number 6002
Distribution
Distributed nationwide across the United States.
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