Valeant Pharmacueticals International: Medical Device Recall in 2016 - (Recall #: Z-0674-2016)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2016.

Data Source: FDA.

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.

Product Classification:

Class II

Date Initiated: September 21, 2015

Date Posted: January 27, 2016

Recall Number: Z-0674-2016

Event ID: 72630

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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

Status: Terminated

Product Quantity: 1178

Code Information:

SPAG 2 Unit, Product Part Number 6002

Distribution Pattern:

USA (nationwide) Distribution and Internationally to Canada and France.

Voluntary or Mandated:

Voluntary: Firm initiated