Device 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.
Z-0368-2019
Product summary
- Event
- Event 80730
- Status
- Terminated
- Classification
- Class II
- Quantity
- 73 units (200 pack)
- Official record key
device-enforcement:Z-0368-2019
Official wording
Reason: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
Code information: 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 pattern: US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
Derived failure modes
-
Foreign material or chemical contamination
extraneous material
-
Manufacturing or process control
manufacturing process error