FDA Device recall Z-0674-2016
Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series
- FDA Device
- Class II
- terminated
- Published 2016-01-27
On 2016-01-27 the FDA classified a Class II recall of Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series by Valeant Pharmacueticals International, citing the Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer a….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0674-2016 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2015-09-21 |
| Published | 2016-01-27 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | Valeant Pharmacueticals International |
| Distribution | US |
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
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Identifiers
| code_info | SPAG 2 Unit, Product Part Number 6002 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0674-2016%22
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