# FDA recall Z-0368-2019

> **3M Company - Health Care Business** · Class II · device recall initiated 2018-07-06.

## 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 for recall

Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

## Distribution

US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.

## Key facts

- **Recall number:** Z-0368-2019
- **Recalling firm:** 3M Company - Health Care Business
- **Classification:** Class II
- **Product type:** device
- **Status:** Terminated
- **Initiation date:** 2018-07-06
- **Report date:** 2018-11-07
- **Termination date:** 2019-02-26

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Saint Paul, MN, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0368-2019

## Citation

> AI Analytics. FDA recall Z-0368-2019. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/Z-0368-2019. Source: US FDA. Licensed CC0.

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