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.
FDA Recall Z-0674-2016 · Posted 2016-01-21
Recalling FirmValeant Pharmacueticals International
Recall StatusTerminated
Product CodeCAF
Date Initiated2015-09-21
Date Terminated2017-05-19
Product Quantity1178
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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Firm 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.
Root Cause
Finished device change control
Distribution Pattern
USA (nationwide) Distribution and Internationally to Canada and France.
Related FDA 510(k) Records
Devices referenced by this recall via K-numbers.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.