Recall Z-0384-2018

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 3.0m, 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.

FDA-determined cause: Device Design

Action taken

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.