Class 2 Device Recall 3M Fast Release Varnish

• Date Initiated by Firm: July 06, 2018
• Create Date: November 02, 2018
• Recall Status: Terminated on February 26, 2019
• Recall Number: Z-0368-2019
• Recall Event ID: 80730
• 510(K)Number: K132109
• Product Classification: Varnish, cavity - Product Code LBH
• 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.
• 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
• Recalling Firm/ Manufacturer: 3M Company - Health Care Business; 3m Center 2510 Conway Ave , B# 275-5-W-6; Saint Paul MN 55144-0001
• For Additional Information Contact: 800-634-2249
• Manufacturer Reason for Recall: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.
• FDA Determined Cause: Mixed-up of materials/components
• Action: On or about 07/06/2018, 3M Health Care notified consignees via phone call or "URGENT Medical Device Recall" letter. Distributors were instructed to examine inventory for affected product, complete and return the Distributor Inventory Checklist to 3M Oral Care, return any affected product on hand, and provide the attached Dentist Letter and Dentist Inventory Checklist to any dentists that may have received the affected product. Dentists were instructed to examine inventory for affected product, complete and return the Dentist Inventory Checklist to 3M Oral Care, and return any affected product on hand. If you have any questions, please contact Regulatory Affairs Manager by telephone at 651-575-8052.
• Quantity in Commerce: 73 units (200 pack)
• Distribution: US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.

• 510(K) Database: 510(K)s with Product Code = LBH