Recall Z-0674-2016 ยท CAF Nebulizer (Direct Patient Interface)
Valeant Pharmacueticals International
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.
| Date | Jan 21, 2016 (initiated Sep 21, 2015) |
| Status | Terminated |
| Reason | The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.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 | 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 (bauschandlomb6443@stericycle.com or fax (844.782.5565). A customer service number was provided in case the customer had any related questions or concerns (1.800.321 |
| Quantity | 1178 |
| Distribution | USA (nationwide) Distribution and Internationally to Canada and France. |
| FDA record | Open on fda.gov |