Valeant Pharmaceuticals North America — Class II medical device recall Z-0674-2016
Terminated recall by Valeant Pharmacueticals International, reported 2016-01-27, distributed nationwide. The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or
| Recall number | Z-0674-2016 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmacueticals International, Bridgewater, NJ, United States |
| Recall initiated | 2015-09-21 |
| Classified | 2016-01-21 |
| Reported by FDA | 2016-01-27 |
| Terminated | 2017-05-19 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, FR |
| Quantity | 1,178 |
| Reason classes | labeling |
| Model numbers | 6002, SPAG-2 |
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.
Reason for recall
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-0674-2016. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.