Recall Z-0674-2016— Valeant Pharmacueticals International

Name: FDA recall Z-0674-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-21

Class II · Terminated

Class II FDA medical device recall by Valeant Pharmacueticals International, initiated 2015-09-21, terminated 2017-05-19. It names 2 FDA 510(k) clearances: K870051, K871427. Product: 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 Reason: The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available..

Recalling firm: Valeant Pharmacueticals International
Classification: Class II
Status: Terminated
Initiated: 2015-09-21
Terminated: 2017-05-19
Firm location: Bridgewater, NJ, United States

510(k) clearances named in this recall

2 on FDA's record

K870051 — SPAG-2 AEROSOL GENERATOR W/USE OF VIRAZOLEViratek, Inc.·cleared 1987-10-06
K871427 — (SPAG) MODEL SPAG-2 6000 SERIESViratek, Inc.·cleared 1987-10-06

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.

Data sourced from openFDA. This site is unofficial and independent of the FDA.