Valeant Pharmacueticals International recalls Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow syste…

Recall date

March 13, 2017

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0384-2018

FDA classification

Class II

Brand / firm

Valeant Pharmacueticals International

Sold / distributed

US Nationwide & Canada

Why it was recalled

SPAG-2 unit nebulizers from Lot J0571670RA were tested at Next Breath for particle sizing under the validated method, NB-TM-261, In November 2016. The particle size specification set in NB-SPEC-039 for Dv10, Dv50, & Dv90 are a mean value of no more than 3.0¿m, 5.5 ¿m, and 15¿m respectively. Initial testing of the nebulizers yielded four units that delivered particle sizes that did not meet the specification (NB-SPEC-039). The out of specification (OOS) nebulizers were cleaned per the approved SPAG-2 procedure, SPE-000127228 Rev 2, to remove any product residue and were then re-evaluated. Secondary testing yielded that three of the four nebulizers still did not meet the particle size specification. It was concluded that the 3 nebulizers from SPAG-2 Lot J0571670RA failed to meet (SPE-000127228 Rev 2) did not resolve the high droplet size distribution values observed.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Small Particle Aerosol Generator Model SPAG-2 6000 Series (SPAG-2). The SPAG-2 medical device is a pneumatic flow system indicated for the administration of Virazole (ribavirin) aerosol. Driven by a pressurized gas (air or blended oxygen) and uses a nebulizer to generate a fine aerosol of hydrated Virazole. --- CDRH Classification Name: Nebulizer (Direct Patient Interface)