Z-0368-2019 Class II Terminated
FDA device recall Z-0368-2019 was initiated by 3M Company - Health Care Business on Jul 6, 2018 and is designated Class II. Reason for recall: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product. The recall status is terminated (terminated Feb 26, 2019). Affected quantity: 73 units (200 pack).
Recall Details
- Product Type
- Devices
- Report Date
- Nov 7, 2018
- Initiation Date
- Jul 6, 2018
- Termination Date
- Feb 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
Source
- Dataset
- openFDA device recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for Z-0368-2019
- openFDA file date
- Oct 23, 2026
- Loaded by RegDataLab
- Oct 26, 2026