Z-0384-2018 Class II Terminated

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)

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.

Lot Number J0571670RA*/Serial Number 337170600007; Lot Number J0571670R*/Serial Number 337170600007; Lot Number J0571670/Serial Number 337170600007; Lot Number L0197340/Serial Number 340150600003; Lot Number K1900650/Serial Number 340150600003.