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 V
Check against the official notice below — it lists the full affected range.
Valeant Pharmaceuticals is recalling SPAG-2 Small Particle Aerosol Generator units and nebulizers because certain units from Lot J0571670RA failed particle size specification tests. During November 2016 testing by Next Breath using validated methods, four nebulizers delivered particles larger than the approved specifications (which set maximum mean values of 3.0 micrometers, 5.5 micrometers, and 15 micrometers for different measurements). After cleaning the units according to approved procedures and retesting, three of the four nebulizers still did not meet the particle size requirements, indicating the cleaning process did not resolve the issue.
The recall affects 418 SPAG-2 units and 808 nebulizers distributed nationwide in the United States and in Canada. The affected products include multiple lot numbers: J0571670RA, J0571670R, J0571670, L0197340, and K1900650, all with Serial Number 337170600007 (except L0197340 and K1900650 which have Serial Number 340150600003). The source document does not specify what action affected consumers should take regarding this recall.
Written by software from the official notice below. Not reviewed by a lawyer.
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.
Reason for recall: 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. Distribution: US Nationwide & Canada Quantity: 418 SPAG-2 and 808 Nebulizers Lot/code info: 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.
Official record: FDA (Device enforcement) ↗
Republished from the official source above; details can change — the source record controls.