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Terminated

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.

FDA Recall Z-1133-2014 · Posted 2014-03-04

Recalling FirmHeraeus Kulzer, LLC.
Recall StatusTerminated
Product CodeKZP
Date Initiated2014-02-10
Date Terminated2014-06-18
Product Quantity812 units (gallons)

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

Firm 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

Root Cause

Labeling mix-ups

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

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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