Recall Z-0368-2019 ยท LBH Varnish, Cavity
3M Company - Health Care Business
3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package containing 1 0.40 ml varnish and 1 applicator brush. Product is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.
| Date | Jul 6, 2018 |
| Status | Terminated |
| Reason | Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. |
| Root cause | Mixed-up of materials/components |
| Action | On or about 07/06/2018, 3M Health Care notified consignees via phone call or "URGENT Medical Device Recall" letter. Distributors were instructed to examine inventory for affected product, complete and return the Distributor Inventory Checklist to 3M Oral Care, return any affected product on hand, and provide the attached Dentist Letter and Dentist Inventory Checklist to any dentists that may have received the affected product. Dentists were instructed to examine inventory for affected product, complete and return the Dentist Inventory Checklist to 3M Oral Care, and return any affected prod |
| Quantity | 73 units (200 pack) |
| Distribution | US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K132109 | ENAMELAST Ultradent Products Inc. / Oratech, LLC, Nov 1, 2013 |