CLASS II Device recall · Reported 27 Jan 2016 · FDA Enforcement Report
Valeant Pharmaceuticals North America recalled
Valeant Pharmacueticals International is recalling Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, Spag-2 6000, distributed nationwide in the US. The recall was initiated on 21 Sep 2015 and the FDA has classified it as Class II.
Check your package
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
Recall details
- Recall number
- Z-0674-2016
- FDA event ID
- 72630
- Recalling firm
- Valeant Pharmacueticals International, Bridgewater, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 21 Sep 2015
- FDA classified
- 21 Jan 2016
- Reported
- 27 Jan 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Device type
- Other Medical Devices
Timeline
| 21 Sep 2015 | Recall initiated by company | |
| 21 Jan 2016 | Classified by FDA | +122 days |
| 27 Jan 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Product as listed by the FDA
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.
Where it was distributed
USA (nationwide) Distribution and Internationally to Canada and France.
Questions about this recall
Is Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, Spag-2 6000 recalled?
Yes. Valeant Pharmacueticals International recalled Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, Spag-2 6000 on 21 Sep 2015. The recall is Class II and its status is Terminated. Recall number Z-0674-2016.
Why was it recalled?
The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Which lots are affected?
SPAG 2 Unit, Product Part Number 6002
Where was it sold?
USA (nationwide) Distribution and Internationally to Canada and France.
What should I do if I have it?
Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Valeant Pharmacueticals International
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Device | CLASS II | Small Particle Aerosol Generator recalled by Valeant Pharmacueticals | Valeant Pharmacueticals International | Potency & Assay | Nationwide |
| Device | CLASS II | Orapharma (Onpharma) Onset Mixing Pen recalled | Valeant Pharmacueticals International | Device Malfunction | Nationwide |
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