Small Particle Aerosol Generator Model SPAG-2 6000 Series — Class II medical device recall Z-0384-2018
Terminated recall by Valeant Pharmacueticals International, reported 2018-01-24, distributed nationwide. SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated
| Recall number | Z-0384-2018 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Valeant Pharmacueticals International, Rochester, NY, United States |
| Recall initiated | 2017-03-13 |
| Classified | 2018-01-17 |
| Reported by FDA | 2018-01-24 |
| Terminated | 2019-06-18 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00337170600007, 00340150600003 |
| Lot numbers | J0571670, K1900650, L0197340 |
| Serial numbers | 337170600007, 340150600003 |
| Model numbers | 6000, PAG-2 |
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 aerosol of hydrated Virazole. --- CDRH Classification Name: Nebulizer (Direct Patient Interface)
Reason for recall
SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated method, NB-TM-261, In November 2016. The particle size specification set in NB-SPEC-039 for Dv10, Dv50, & Dv90 are a mean value of no more than 3.0¿m, 5.5 ¿m, and 15¿m respectively. Initial testing of the nebulizers yielded four units that delivered particle sizes that did not meet the specification (NB-SPEC-039). The out of specification (OOS) nebulizers were cleaned per the approved SPAG-2 procedure, SPE-000127228 Rev 2, to remove any product residue and were then re-evaluated. Secondary testing yielded that three of the four nebulizers still did not meet the particle size specification. It was concluded that the 3 nebulizers from SPAG-2 Lot J0571670RA failed to meet (SPE-000127228 Rev 2) did not resolve the high droplet size distribution values observed.
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-0384-2018. 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.