Device 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.
Z-1133-2014
Product summary
- Event
- Event 67475
- Status
- Terminated
- Classification
- Class II
- Quantity
- 812 units (gallons)
- Official record key
device-enforcement:Z-1133-2014
Official wording
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
Code information: Part #1010-451 Lot #13121434
Distribution pattern: 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
Derived failure modes
-
Labeling or packaging
incorrect labeling