Dharma Cavity Varnish recall
Dharma Cavity Varnish 15mL
Why was Dharma Cavity Varnish recalled?
During an FDA inspection it was found that the products are marketed without a cleared 510k.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
All Lots - Item # 14-00016
- Product
- Dharma Cavity Varnish 15mL
- Recalling firm
- Dharma Research, Inc.
- Quantity
- 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.
- Recall date
- December 3, 2014
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (device)