Home / Recalls / Valeant Pharmacueticals International / Z-0674-2016

Z-0674-2016 Class II Terminated

Recalled by Valeant Pharmacueticals International — Bridgewater, NJ

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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.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