Recall Z-2151-2014— Coltene Whaledent Inc
Class II · Terminated
Class II FDA medical device recall by Coltene Whaledent Inc, initiated 2013-12-11, terminated 2016-08-26. FDA's recall record names no specific 510(k) clearance for this event. Product: Latex Dental Dams labeled as Non-Latex Dental Dams. Reason: Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging..
- Recalling firm
- Coltene Whaledent Inc
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-12-11
- Terminated
- 2016-08-26
- Firm location
- Cuyahoga Falls, OH, United States
Product description
Latex Dental Dams labeled as Non-Latex Dental Dams
Reason for recall
Colt¿ne/Whaledent Inc. received a complaint about the dental dams being the incorrect color. During an internal investigation, the firm found that Latex dental dams had been packaged in Non-Latex packaging.
Data sourced from openFDA. This site is unofficial and independent of the FDA.