Recall record at a glance
| Official record | Z-0384-2018 |
|---|---|
| Category | Medical Device Recalls |
| Classification | Class II |
| FDA record status | Terminated |
| Recalling firm | Valeant Pharmacueticals International |
| Report date | Jan 24, 2018 |
| Recall initiation date | Mar 13, 2017 |
| Quantity | 418 SPAG-2 and 808 Nebulizers |
| Location | Rochester, NY, United States |
Official product description
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)
Why the product 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.
Distribution information
US Nationwide & Canada
How to read the classification
FDA Class II indicates a situation in which use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or where the probability of serious consequences is remote. The classification shown here comes from the FDA record.
Additional record details
Recall type: Voluntary: Firm initiated. Initial notification: Letter.
What to do next
If you believe you have the recalled product, use the recall number and firm information above to confirm the official notice and follow the instructions issued by the FDA, recalling firm, retailer or product manufacturer. For drugs and medical devices, decisions about treatment or medical care should be discussed with a qualified health professional.
About this record
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