Z-0674-2016 Class II Terminated
FDA device recall Z-0674-2016 was initiated by Valeant Pharmacueticals International on September 21, 2015 and is designated Class II. 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recall: The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available. The recall status is terminated (terminated May 19, 2017). Affected quantity: 1178.
Recall Details
- Product Type
- Devices
- Report Date
- January 27, 2016
- Initiation Date
- September 21, 2015
- Termination Date
- May 19, 2017
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1178
Product Description
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.
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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
Distribution Pattern
USA (nationwide) Distribution and Internationally to Canada and France.
Code Information
SPAG 2 Unit, Product Part Number 6002