Recall Z-0476-2015— Dharma Research, Inc.
Class II · Terminated
Class II FDA medical device recall by Dharma Research, Inc., initiated 2014-09-29, terminated 2016-10-03. FDA's recall record names no specific 510(k) clearance for this event. Product: Dharma Cavity Varnish 15mL. Reason: During an FDA inspection it was found that the products are marketed without a cleared 510k..
- Recalling firm
- Dharma Research, Inc.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-09-29
- Terminated
- 2016-10-03
- Firm location
- Miami, FL, United States
Product description
Dharma Cavity Varnish 15mL
Reason for recall
During an FDA inspection it was found that the products are marketed without a cleared 510k.
Data sourced from openFDA. This site is unofficial and independent of the FDA.