FDA Device recall Z-0368-2019
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…
- FDA Device
- Class II
- terminated
- Published 2018-11-07
On 2018-11-07 the FDA classified a Class II 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… by 3m Health Care Business, citing product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0368-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2018-07-06 |
| Published | 2018-11-07 |
| Last updated | 2026-09-13 11:54 UTC |
| Company | 3m Health Care Business |
| Distribution | CA, FL, IN, NV, PA, TN, TX, WA |
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.
Reason
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Identifiers
| code_info | Catalogue Code: 12158M, 3M ID Number 70-2014-0568-8, Lot Number BFLSB, Lot # BFLSB, Expiration Date 2020-02, GTIN (cons…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 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:54 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0368-2019%22
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