Class 2 Device Recall SPAG2 unit nebulizers

• Date Initiated by Firm: March 13, 2017
• Create Date: January 17, 2018
• Recall Status: Terminated on June 18, 2019
• Recall Number: Z-0384-2018
• Recall Event ID: 77289
• 510(K)Number: K871427
• Product Classification: Nebulizer (direct patient interface) - Product Code CAF
• 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)
• Code Information: 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.
• Recalling Firm/ Manufacturer: Valeant Pharmacueticals International; 1400 Goodman St N; Rochester NY 14609-3547
• For Additional Information Contact: 888-965-6127
• Manufacturer 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: 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 in Commerce: 418 SPAG-2 and 808 Nebulizers
• Distribution: US Nationwide & Canada
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = CAF