Z-0368-2019 Class II Terminated
Recall Details
- Product Type
- Devices
- Report Date
- November 7, 2018
- Initiation Date
- July 6, 2018
- Termination Date
- February 26, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 73 units (200 pack)
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.
Distribution Pattern
US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
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