Recall Z-0371-2016— Valeant Pharmaceuticals North America LLC

Name: FDA recall Z-0371-2016
Creator: U.S. Food and Drug Administration
Published: 2015-09-14

Class II · Terminated

Class II FDA medical device recall by Valeant Pharmaceuticals North America LLC, initiated 2015-09-14, terminated 2017-06-27. It names 2 FDA 510(k) clearances: K870051, K871427. Product: Valeant Pharmaceuticals North America Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole. Reason: SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515..

Recalling firm: Valeant Pharmaceuticals North America LLC
Classification: Class II
Status: Terminated
Initiated: 2015-09-14
Terminated: 2017-06-27
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 Model No. Spag-2 Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole

Reason for recall

SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.

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