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.
Reported: November 7, 2018 Initiated: July 6, 2018 #Z-0368-2019
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.
Reason for Recall
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Details
- Recalling Firm
- 3M Company - Health Care Business
- Units Affected
- 73 units (200 pack)
- Distribution
- US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
- Location
- Saint Paul, MN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by 3M Company - Health Care Business. Units affected: 73 units (200 pack).
Why was this product recalled? ▼
Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on November 7, 2018. Severity: Moderate. Recall number: Z-0368-2019.
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