Z-0674-2016Class II

Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No...

Name: Z-0674-2016 Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No...
Creator: Valeant Pharmacueticals International
Published: 2015-09-21
License: https://open.fda.gov/license/

Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International) / initiated 2015-09-21 / Terminated / root cause: labeling and UDI

FDA source

Valeant Pharmacueticals International began a recall of Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the... on 2015-09-21. FDA classified it as Class II and gives the reason as "The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as labeling and UDI.

Recall record

Recall number: Z-0674-2016
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Posted: 2016-01-21
Terminated: 2017-05-19
Recalling firm: Bausch Health Americas, Inc. (f/k/a Valeant Pharmaceuticals International)
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.
Product code: CAF Nebulizer (Direct Patient Interface)
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recall: The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Root cause tag: labeling and UDI
FDA root cause: Finished device change control
Action: Valeant Pharmaceuticals International, Inc. sent Field Correction Notifications /Recall Stock Response Form dated September 22, 2015 through 2nd day air service to their customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. T The customers were requested to fill out and return the attached Recall Stock Response Form and return the form via email ([email protected] or fax (844.782.5565). A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576) On October 7, 2015 a second field correction notification was sent to customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576). The updated notification clarified that the notification applies to all SPAG-2 6000 model units currently in the market.
Quantity in commerce: 1178
Distribution: USA (nationwide) Distribution and Internationally to Canada and France.
Product codes and lots: SPAG 2 Unit, Product Part Number 6002

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0674-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0674-2016	Class II	Terminated	Voluntary: Firm initiated	2016-01-27	2016-01-21

Product code CAF

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)