Recall Z-0368-2019
3M Company - Health Care Business · initiated July 6, 2018
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: 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
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 taken
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.
Details
- Recall number
- Z-0368-2019
- Initiated
- July 6, 2018
- Terminated
- February 26, 2019
- Product code
- LBH – Varnish, Cavity
- Quantity
- 73 units (200 pack)
- Distribution
- US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.
- Recalling firm
- 3M Company - Health Care Business, Saint Paul, MN