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The Serial I.D. Label and some information in the Operation Manual for the SPAG 2 6000 series is incorrect or out of date, including references to accessories that are no longer available.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
|
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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.
|