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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 80730

1 recalled-product record grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
July 06, 2018
Product types
Device
Classifications
Class II
Statuses
Terminated
Recalling firm wording
3M Company - Health Care Business

Dossier provenance

Source snapshots represented here

  • openFDA Device Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
  • openFDA Device Recall event_date_initiated coverage June 01, 1997–June 30, 2026

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

1 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

device · product 1 of 1

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
Recall number
Z-0368-2019
Initiated
July 06, 2018
Classification
Class II
Status
Terminated
Quantity
73 units (200 pack)

App-derived interpretation

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

These labels are deterministic app interpretations, not FDA categories.

Official device-enrichment evidence · Sourced

Mixed-up of materials/components

Compare all device evidence states

Inspect official wording and provenance

Reason for recall

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.