| Class 2 Device Recall Dharma Cavity Varnish |  |
Date Initiated by Firm | September 29, 2014 |
Date Posted | December 01, 2014 |
Recall Status1 |
Terminated 3 on October 03, 2016 |
Recall Number | Z-0476-2015 |
Recall Event ID |
69386 |
Product Classification |
Varnish, cavity - Product Code LBH
|
Product | Dharma Cavity Varnish 15mL |
Code Information |
All Lots - Item # 14-00016 |
Recalling Firm/ Manufacturer |
Dharma Research, Inc. 5220 Nw 72nd Ave Bay 15 Miami FL 33166-4860
|
For Additional Information Contact | Ricardo A. Carles 305-482-9669 |
Manufacturer Reason for Recall | During an FDA inspection it was found that the products are marketed without a cleared 510k. |
FDA Determined Cause 2 | No Marketing Application |
Action | On September 29, 2014 the firm sent a notification to its consignees informing them of the product being discountued and removed. The firm asked for the product to be returned directly to Dharma's office at 5220 NW 72 Avenue, Suite 15, Miami FL 33166. For any questions please do not hesitate to call (305) 482-9669. |
Quantity in Commerce | 916 |
Distribution | Worldwide Distribution: US Distribution in states of: CA, PA, FL, IL, including Puerto Rico; and countries of: Honduras, Dominican Republic, Turkey, Nicaragua, Colombia, Pakistan, Trinidad & Tobago, Guatemala, Phillipines, Saudi Arabia, and United Arab Emirates. |
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.
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