Fast Release Varnish recallZ-0368-2019 · 3M Company - Health Care Business · initiated Jul 6, 2018
Terminated
Is my device affected?
- Compare the model, catalog and lot or serial numbers on your device or its packaging with the code information below. A recall usually covers only specific models or lots.
- If yours is listed, follow the instructions from 3M Company - Health Care Business or your healthcare provider. The company's action is summarized under what the company is doing.
- Do not stop using a prescribed or implanted device on your own — talk to your healthcare provider first.
Where to find your model and lot numbers · What recall classes and statuses mean
Why it was recalled
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
FDA root cause category: Mixed-up of materials/components
What the company is doing
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.
Recall details
- Recall number
- Z-0368-2019
- Status
- Terminated
- Initiated by the company
- Jul 6, 2018
- Recalling firm
- 3M Company - Health Care Business
- Quantity
- 73 units (200 pack)
- Product code
- LBH
- FDA submissions
- K132109
- Distribution
- US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
Product description
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.
Code information (models, lots, serial numbers)
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
Devices named in this recall
1 device in the FDA device registry whose identifier appears in the recall's code information.
- Fast Release Varnish 12158M3m Company · VARNISH, CAVITY1 recall0 reports
Product lines
Sources and updates
- Recall record: FDA Medical Device Recalls, file dated Oct 16, 2026 · View the FDA recall notice ↗
- Devices: FDA GUDID, file dated Oct 13, 2026. Devices are linked when their identifier (with a valid check digit) appears in the recall's code information.
- Page last rebuilt: Oct 16, 2026. Text above is shown as published by the FDA.
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