Recall Z-0690-2019 ยท LBH Varnish, Cavity
Ultradent Products, Inc.
Enamelast Cool Mint/OT Varnish 5% NaF Mint Label Enamelast Unit Dose 200pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 200pk Kit - Cool Mint REF/UP 4352 Rx CONTENTS: 200 x 0.4 ml Unit Dose Label Enamelast Unit Dose 50pk Cool Mint: Enamelast 5% Sodium Fluoride Unit Dose 50pk Kit - Cool Mint REF/UP 4353 Rx CONTENTS: 50 x 0.4 ml Unit Dose Manufactured by Ultradent Products Inc. ****La
| Date | Jul 12, 2018 |
| Status | Terminated |
| Reason | Dental varnish has the possibility of having an unpleasant and off flavor. |
| Root cause | Mixed-up of materials/components |
| Action | On July 3, 2018, the firm sent an URGENT PRODUCT CORRECTION Notification to customers via UPS informing them that the Cool Mint flavor Fluoride Varnish has the possibility of having an unpleasant and off flavor, atypical of the refreshing cool mint flavor that they are used to. If the customer has any questions regarding this correction or directions to the actions required, please contact Adam Black at 801-553-4425 or Karen Kakunes at 801-553-4366. Customer are instructed to take the following actions for tracing and documentation purposes: -Discard remaining inventory of Enamelast Cool M |
| Quantity | 1654 units |
| Distribution | Worldwide Distribution - US Nationwide: AK, AL, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, Puerto Rico, RI, SC, TN, TX, UT, VA, VT, WA, WI, WV, and WY OUS: Germany, Italy, Malaysia, and Poland |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132109 | ENAMELAST Ultradent Products Inc. / Oratech, LLC, Nov 1, 2013 |