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U.S. Department of Health and Human Services

Class 2 Device Recall Valeant Pharmacueticals International SPAG 2 6000

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  Class 2 Device Recall Valeant Pharmacueticals International SPAG 2 6000 see related information
Date Initiated by Firm September 21, 2015
Date Posted January 21, 2016
Recall Status1 Terminated 3 on May 19, 2017
Recall Number Z-0674-2016
Recall Event ID 72630
510(K)Number K871427  K870051  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product Valeant Pharmaceuticals North America, Small Particle Size Aerosol Generator, SPAG-2 6000 series. Model No. SPAG-2. A nebulizer pneumatic flow system for the administration of Virazole (ribavirin) aerosol.
Code Information SPAG 2 Unit, Product Part Number 6002
Recalling Firm/
Manufacturer		 Valeant Pharmacueticals International
400 Somerset Corporate Blvd
Bridgewater NJ 08807-2867
For Additional Information Contact Mr. Hunter Manuel
317-957-3319
Manufacturer Reason
for Recall		 The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.
FDA Determined
Cause 2		 Finished device change control
Action Valeant Pharmaceuticals International, Inc. sent Field Correction Notifications /Recall Stock Response Form dated September 22, 2015 through 2nd day air service to their customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. T The customers were requested to fill out and return the attached Recall Stock Response Form and return the form via email (bauschandlomb6443@stericycle.com or fax (844.782.5565). A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576) On October 7, 2015 a second field correction notification was sent to customers. The notification informed the customer about the field correction, how to identify affected product and what actions to take. A customer service number was provided in case the customer had any related questions or concerns (1.800.321.4576). The updated notification clarified that the notification applies to all SPAG-2 6000 model units currently in the market.
Quantity in Commerce 1178
Distribution USA (nationwide) Distribution and Internationally to Canada and France.
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 and Original Applicant = VIRATEK, INC.
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