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Recall Observatory FDA recall evidence

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

February 10, 2014

Class II

Product summary

Firm
Heraeus Kulzer, LLC.
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

    reason.labeling_packaging · v1.0.0

    incorrect labeling