3M Fast Release Varnish Recalled for Unpleasant Flavor
3M is recalling 73 units of Fast Release Varnish due to a manufacturing error that introduced extraneous material, causing an unpleasant flavor.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is for a cosmetic defect (unpleasant flavor) with no reported health hazards or injuries, fitting the criteria for a Low severity score.
Plain-English summary
3M Company - Health Care Business is recalling 73 units of 3M Fast Release Varnish, 5% Sodium Fluoride, Mint Flavor. The product is a single-use dental varnish used to seal dentinal tubules and treat hypersensitive teeth. Each package contains one 0.40 ml varnish and one applicator brush.
The recall is due to a manufacturing process error that resulted in an extraneous material being introduced into the product. This error caused the product to have an unpleasant flavor. The affected lot number is BFLSB, with an expiration date of 2020-02.
The affected units were distributed in the United States to the states of California, Florida, Indiana, Nevada, Pennsylvania, Tennessee, Texas, and Washington. Consumers and dental professionals should stop using the product and contact 3M for further instructions.
The recalled product
- 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.
- Manufacturer
- 3M Company - Health Care Business
- Category
- Medical Device — Dental Varnish
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (7)
- 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
Distribution
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