Recall Z-1133-2014— Heraeus Kulzer, LLC.
Class II · Terminated
Class II FDA medical device recall by Heraeus Kulzer, LLC., initiated 2014-02-10, terminated 2014-06-18. FDA's recall record names no specific 510(k) clearance for this event. Product: BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.. Reason: As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C.
- Recalling firm
- Heraeus Kulzer, LLC.
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2014-02-10
- Terminated
- 2014-06-18
- Firm location
- South Bend, IN, United States
Product description
BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calculus, tartar, tobacco and food stains from dentures, bridges, orthodontic appliances, etc. Use also for removal of permanent cement.
Reason for recall
As the result of a complaint to Heraeus Kulzer's customer service department, Heraues Kulzer is recalling Benco Tartar and Stain Solution part #1010-451, lot #13121434 because it has incorrect labeling on the immediate container. While the outer carton correctly states "Benco Tartar and Stain", the immediate gallon container in which the solution is contained incorrectly states "Benco Temporary C
Data sourced from openFDA. This site is unofficial and independent of the FDA.