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Recall Observatory FDA recall evidence

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.

Z-0368-2019

July 06, 2018

Class II

Product summary

Firm
3M Company - Health Care Business
Event
Event 80730
Status
Terminated
Classification
Class II
Quantity
73 units (200 pack)
Official record key
device-enforcement:Z-0368-2019

Official wording

Reason: Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

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

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

Derived failure modes

  • Foreign material or chemical contamination

    reason.foreign_material_chemical_contamination · v1.0.0

    extraneous material
  • Manufacturing or process control

    reason.manufacturing_process_control · v1.0.0

    manufacturing process error