Severity
Moderate
ModerateClass IITerminated
FDA Devices recall · Reported January 24, 2018
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)
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 …
Valeant Pharmacueticals International recalled Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical de… - a moderate-severity action.
Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical de… was recalled by Valeant Pharmacueticals International in January 24, 2018. Reason: SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated…. Check the official notice for the remedy. Verify recall #Z-0384-2018 with the FDA Devices before acting.
The recall
Valeant Pharmacueticals International issued this moderate-severity FDA Devices recall-SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated….
- Moderate
- severity level
- Class II
- classification
- January 24, 2018
- reported
Sourced from official FDA Devices enforcement records. Verify recall #Z-0384-2018 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Devices action (record #Z-0384-2018) was formally reported on January 24, 2018, with the manufacturer initiating the action on March 13, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. Valeant Pharmacueticals International is listed as the recalling firm, operating out of Rochester, NY. Federal records list the affected scope as 418 SPAG-2 and 808 Nebulizers.
The documented reason for this recall is: 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, & Dv9… Distribution data in the federal record shows the product reached: US Nationwide & Canada. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 3 from FDA Devices - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Medical Devices recalls over time
Where this recall sits in its category - 40,322 medical devices recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
418 SPAG-2 and 808 Nebulizers
Related Recalls
6
3 from same agency
Product description
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | Z-0384-2018 |
| Date reported | January 24, 2018 |
| Date initiated | March 13, 2017 |
| Recalling firm | Valeant Pharmacueticals International |
| Firm location | Rochester, NY |
| Affected scope | 418 SPAG-2 and 808 Nebulizers |
| Distribution | US Nationwide & Canada |
Profile values are sourced directly from the official FDA Devices enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (Z-0384-2018) and product description against the item you own. Search the archive
- Confirm the current status with FDA Devices before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Devices record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Valeant Pharmacueticals International. Units affected: 418 SPAG-2 and 808 Nebulizers.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 24, 2018. Severity: Moderate. Recall number: Z-0384-2018.
Where was the recalled product distributed? ▼
Distribution: US Nationwide & Canada.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (Z-0384-2018) against your product. Visit the official FDA Devices website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Devices, reported January 24, 2018. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.