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U.S. Department of Health and Human Services

Class 2 Device Recall Valeant Pharmaceuticals International

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  Class 2 Device Recall Valeant Pharmaceuticals International see related information
Date Initiated by Firm September 14, 2015
Date Posted December 04, 2015
Recall Status1 Terminated 3 on June 27, 2017
Recall Number Z-0371-2016
Recall Event ID 72198
510(K)Number K870051  K871427  
Product Classification Nebulizer (direct patient interface) - Product Code CAF
Product Valeant Pharmaceuticals North America Model No. Spag-2
Small Particle Size Aerosol Generator SPAG-2 6000 is a pneumatic flow system indicated for the administration of Viazole uses a nebulizer to generate a fine aerosol of hydrated Virazole
Code Information Lot #J3522070  Serial numbers 23461 23463 23466 23467 23468 23469 23472 23475 23477 23479 23480 23481 23482 23484 23485 23486 23487 23488 23489 23490 23491 23492 23493 23495 23503 23504 23505 23506 23507 23508 23509 23510 23512 23513 23514 23515 23517 23520 23521 23524 23529 23530 23531 23532 23535 23536 23540 23547 23558 23560 23568 23569 23570 23571 23572 23579 23587 23589 23590 23592 23593
Recalling Firm/
Manufacturer		 Valeant Pharmaceuticals North America LLC
400 Somerset Corporate Blvd
Bridgewater NJ 08807-2867
For Additional Information Contact Mr. Veerarajendra (Raj) B Yadwad
908-514-1956
Manufacturer Reason
for Recall		 SPAG-2 6000 Lot J3522070 was released to commerce without being tested for particle size per quality control procedure SPAG-2515.
FDA Determined
Cause 2		 Under Investigation by firm
Action Valeant Pharmaceuticals International issued recall letter/return response form dated 9/11/2015 via 2nd day air service Customers were requested to check their inventory for the SPAG-2 device and sgregate it for return shipment.
Quantity in Commerce 61 units
Distribution AL, AZ, CA, CO, IL, OH, MO, NC, NY, PA., SC, UT and TX
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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