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.

Recall Insight

This FDA Devices action (record #Z-0674-2016) was formally reported on January 27, 2016, with the manufacturer initiating the action on September 21, 2015. 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 Bridgewater, NJ. Federal records indicate 1178 units are affected.

The documented reason for this recall is: The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available. Distribution data in the federal record shows the product reached: USA (nationwide) Distribution and Internationally to Canada and France.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC and NHTSA going back to 1995. Within the same product category, the database holds 6 closely related recalls, of which 6 were also issued by FDA Devices. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 10 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.