BencoDental tartar & stain remover ultrasonic cleaning solution Product Usage: Formulated especially for removal of calc

FDA device recall Z-1133-2014 · posted 2014-03-04 · Terminated

Recall details

Recalling firm

Heraeus Kulzer, LLC.

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

Action taken

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

Status

Terminated

Product code

KZP

Quantity affected

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

Date initiated

2014-02-10

Date posted

2014-03-04

Date terminated

2014-06-18

Location

South Bend, IN