FDA recall Z-0368-2019

3M Company - Health Care Business · Class II · 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.

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

US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.

Key facts

Status
Terminated
Initiation date
2018-07-06
Report date
2018-11-07
Termination date
2019-02-26
Voluntary/Mandated
Voluntary: Firm initiated
Location
Saint Paul, MN, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0368-2019