Recall Z-1133-2014 ยท KZP Solution, Cement Dissolving
Heraeus Kulzer, LLC.
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.
| Date | Mar 4, 2014 (initiated Feb 10, 2014) |
| Status | Terminated |
| 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 |
| Root cause | Labeling mix-ups |
| Action | Heraeus Kulzer, notified their one consignee of the recall February 4, 2014 via phone and then by official electronic notification. On February 7, 2014, an Important Communication Product Recall letter was also mailed to Benco direct accounts. On 2/10/14, Heraeus Kulzer also called Benco customers notifying them of the recall. The notifications explained the issue, identified the affected product and actions to be taken. For questions call 574-293-5444 |
| Quantity | 812 units (gallons) |
| Distribution | USA Nationwide Distribution in the states AL, AR, AZ, CA, CO, FL, GA, IL, IN, KS, KY, LA, MI, MN, MO, MS, NC, ND, NE, NM, NV, OH, OK, PA, SC, TN, TX, UT, VA, WA, WI, WV |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.