{ "meta": { "disclaimer": "Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service.", "terms": "https://open.fda.gov/terms/", "license": "https://open.fda.gov/license/", "last_updated": "2026-08-13", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "166237", "product_res_number": "Z-0368-2019", "event_date_initiated": "2018-07-06", "event_date_created": "2018-11-02", "recall_status": "Terminated", "event_date_terminated": "2019-02-26", "res_event_number": "80730", "product_code": "LBH", "k_numbers": [ "K132109" ], "product_description": "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. \n\nProduct is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth.", "code_info": "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", "firm_fei_number": "2110898", "recalling_firm": "3M Company - Health Care Business", "address_1": "3m Center 2510 Conway Ave , B# 275-5-W-6 2510 3m center conway ave b# 275-5-w-6", "city": "Saint Paul", "state": "MN", "postal_code": "55144-0001", "additional_info_contact": "800-634-2249", "reason_for_recall": "Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.", "root_cause_description": "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. \n\nDentists 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.\n\nIf you have any questions, please contact Regulatory Affairs Manager by telephone at 651-575-8052.", "product_quantity": "73 units (200 pack)", "distribution_pattern": "US distribution to states of: CA, FL, IN, NV, PA, TN, TX and WA.", "openfda": { "k_number": [ "K955521", "K010957", "K994181", "K122908", "K241489", "K051750", "K181965", "K243777", "K231060", "K132109", "K082594", "K900946", "K040473", "K994180", "K103160", "K080228", "K160377", "K241568", "K250714", "K992822", "K946032", "K191453", "K103461", "K801047", "K072342", "K070289", "K810913", "K082198", "K140481", "K062683", "K833701", "K073061", "K945794", "K802926", "K812548", "K052263", "K092141", "K864050", "K973919", "K090519", "K974398", "K851030", "K021805", "K760660", "K901049", "K982915", "K990779", "K093575", "K082071", "K090597", "K031932", "K242913", "K231338", "K080814", "K131376", "K070070", "K190271", "K953168", "K963979", "K122708", "K100172", "K002581", "K061359", "K924982", "K944934", "K933505", "K974202", "K093620", "K983305", "K030922", "K073117", "K021131", "K220419", "K852755", "K124025", "K233768", "K961893", "K120109", "K222891", "K140349", "K192381", "K120176", "K122331", "K072338", "K113146", "K981972", "K040098", "K132426", "K061438", "K812550", "K925375", "K992629", "K901915", "K182917", "K033295", "K200614", "K860633", "K924827", "K143155", "K003482", "K994182", "K832497", "K140350", "K080249", "K112946", "K931096", "K200077", "K100540", "K852756", "K030488", "K123653", "K252073", "K131487", "K013411", "K151302", "K062176", "K141422", "K800438", "K261404", "K260830", "K953167", "K102808", "K760982", "K230333", "K083036", "K040858", "K253052", "K864051", "K153334", "K100503", "K864052", "K010255", "K880741", "K023671", "K050486", "K071267", "K881026", "K851052" ], "device_name": "Varnish, Cavity", "medical_specialty_description": "Dental", "regulation_number": "872.3260", "device_class": "2", "registration_number": [ "3006805063", "1450653", "8010908", "3012494290", "3012996495", "2424472", "9610902", "2133714", "1723973", "3042272797", "3012117640", "3003896222", "3010002722", "3025666291", "9680945", "3045857207", "1215305", "9613953", "9612300", "3012187973", "1000272892", "3000219976", "3010131268", "1420052", "2437780", "3009496224", "2022039", "2242327", "3010065389", "3026630", "1051594", "2429849", "3003621174", "1725006", "2086043", "3021035729", "3038718579", "1218077", "3032163716", "2511556", "3031841433", "3044819802", "1718912", "3012421607", "3005686375", "2244812", "9611385", "1013257", "3004475754", "3027584973", "3011430871", "2244842", "3005665377", "3003449480", "3002808149", "3004967419", "1413475", "1319130", "1721647", "3004140838", "3002807050", "3028011", "2183301", "1410097", "2018957", "2218158", "3012118920", "1281412", "3009603151", "3045816931", "3006444232", "3010864832", "9612352", "1061053", "3043226252", "3026400121", "3011632", "1941138", "3013584861", "9681356", "1833025", "9615332", "3002807420", "2523320", "2515379", "2031532", "3014615644", "3004966444", "2513595", "9680144", "3007113445", "9611959", "2214133" ], "fei_number": [ "3006805063", "1450653", "3012494290", "3003258642", "3012996495", "3002989672", "3002808636", "3042272797", "3012117640", "3010002722", "3025666291", "1000150986", "3045857207", "1215305", "3001236822", "3012187973", "1000272892", "3000219976", "3010131268", "1420052", "3009496224", "2022039", "2242327", "3001746544", "3010065389", "3002807052", "1051594", "3010687142", "2429849", "3006349398", "1000251162", "3003621174", "3038718579", "3021035729", "1218077", "3032163716", "2511556", "3031841433", "3044819802", "3002718942", "3002807166", "1718912", "1000126901", "3012421607", "1000582314", "3002808289", "2244812", "1013257", "3004475754", "3027584973", "3011430871", "2244842", "3005665377", "3003449480", "3002808149", "3002677549", "3004967419", "3000719964", "1413475", "1319130", "1721647", "3004140838", "3002807050", "3003422682", "3002088145", "2183301", "1410097", "2018957", "3012118920", "1281412", "3009603151", "1000511545", "3045816931", "3006444232", "3043226252", "3000209941", "3026400121", "2221095", "3011632", "1941138", "3013584861", "3002806930", "1833025", "3010862763", "3002807420", "2523320", "2515379", "3014615644", "3004966444", "3002729120", "2513595", "3007113445", "2214133" ] } } ] }