Z-0368-2019Class II

3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package...

Name: Z-0368-2019 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor, Rx Only, single use. 200 pack, with each package...
Creator: 3M Company - Health Care Business
Published: 2018-07-06
License: https://open.fda.gov/license/

3M Company / initiated 2018-07-06 / Terminated / root cause: manufacturing process

FDA source

3M Company - Health Care Business began a recall of 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... on 2018-07-06. FDA classified it as Class II and gives the reason as "Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product". As of 2026-09-10, the recall status on record is Terminated, and MDM tags the root cause as manufacturing process.

Recall record

Recall number: Z-0368-2019
Classification: Class II
Status: Terminated
Initiated: 2018-07-06
Posted: 2018-11-02
Terminated: 2019-02-26
Recalling firm: 3M Company
Product: 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.
Product code: LBH Varnish, Cavity
Reason for recall: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Root cause tag: manufacturing process
FDA 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 product on hand. If you have any questions, please contact Regulatory Affairs Manager by telephone at 651-575-8052.
Quantity in commerce: 73 units (200 pack)
Distribution: US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
Product codes and lots: Catalogue Code: 12158M, 3M ID Number 70-2014-0568-8, Lot Number BFLSB, Lot # BFLSB, Expiration Date 2020-02, GTIN (consumer primary carton) 30605861060661, GTIN (shipper) 50605861060665

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-0368-2019
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-0368-2019	Class II	Terminated	Voluntary: Firm initiated	2018-11-07	2018-11-01

Product code LBH

K132109Class IIEnamelastUltradent Products Inc. / Oratech, LLC / cleared 2013-11-01

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)