Valeant Pharmacueticals International: 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)

Recall number

Z-0384-2018

Recalling firm

Valeant Pharmacueticals International

Product

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)

Status

Terminated

Initiated

2017-03-13

Posted

not on file

Terminated

2019-06-18

Reason

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 3.0m, 5.5 m, and 15m 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.

Root cause

Device Design

Action

On April 4, 2017 Valeant Pharmaceuticals North America distributed Medical Device Voluntary Product Recall and Acknowledgement Forms to their customers via USPS. Valeant Pharmaceuticals are directly contacting those customers who have been shipped affected SPAG-2 devices to arrange pick up and testing of the nebulizer component. Only half of the nebulizers will be picked-up for particle-size testing at each account to prevent shortages of VIRAZOLE, which can only be used with the SPAG-2 device. Nebulizers that pass testing will be cleaned and returned. Nebulizers that do not pass testing will be disposed, and new nebulizers will be distributed to facilities once they become available. Customers are encouraged to complete and return the Acknowledgement Form via email to: valeant3012@stericycle.com.

Quantity

418 SPAG-2 and 808 Nebulizers

Distribution

US Nationwide & Canada

Lot, serial or model codes

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.

510(k) numbers

["K871427"]

PMA numbers

not on file

Product code

CAF

Firm FEI

3009443653

Firm city

Rochester

Firm state

NY

Firm country

not on file

Cite as

FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28

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