{ "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": "196100", "product_res_number": "Z-0103-2023", "event_date_initiated": "2022-09-07", "event_date_posted": "2022-10-20", "recall_status": "Open, Classified", "res_event_number": "90870", "product_code": "HCG", "k_numbers": [ "K172390", "K200030" ], "product_description": "Optima Coil System \n\nModel Number OPTI0208CSS10, \n\nModel Number OPTI0308CSS10. Used in endovascular procedures.", "code_info": "Model Number: OPTI0208CSS10\nUDI-DI Code: 00818053025815\nLot Number: F220601068\n\nModel Number: OPTI0308CSS10\nUDI-DI Code: 00818053025891\nLot Number: F220601089", "firm_fei_number": "3014162263", "recalling_firm": "BALT USA, LLC", "address_1": "29 Parker Ste 100 29 Parker", "address_2": "Ste 100", "city": "Irvine", "state": "CA", "postal_code": "92618-1667", "additional_info_contact": "Mr. Moises Colin\n949-788-1443 Ext. 765", "reason_for_recall": "Product pouch label does not match up with carton label", "root_cause_description": "Error in labeling", "action": "On 09/07/2022, the firm sent an \"URGENT MEDICAL DEVICE RECALL\" Letter via priority mail to customer informing them that Balt USA was informed that one device had information on the pouch label that differed from the information on the carton label. This hazard presents a high risk to patient safety with the possibility that the user could inadvertently select the wrong size coil for a procedure.\n\nDistributor/Subsidiaries are instructed to:\n-Inform customers about this notice.\n-Return to Balt USA products from Lot #F2206001068 and Lot #F220601089\n\nDirect Customers are instructed to:\n-Inform within their hospital Safety Office, Pharmacists, Head of Neuroradiology and staff of Recall.\n-Return to Balt USA products from Lot #F2206001068 and Lot #F220601089\n\nFor questions or assistance - contact Balt USA Quality Department at\nemail - QA@baltgroup.com\ntelephone number - 949-788-1443 or Fax 949-788-1444", "product_quantity": "41 impacted devices", "distribution_pattern": "Worldwide distribution - U.S. Nationwide distribution in the states of FL, GA, NC, and PA. The countries of Dominican Republic, India and Japan.", "openfda": { "k_number": [ "K092666", "K053548", "K223386", "K141134", "K961923", "K050954", "K171747", "K082324", "K920324", "K142513", "K123560", "K951256", "K071634", "K143218", "K010026", "K073442", "K090168", "K911779", "K161367", "K993417", "K901721", "K050700", "K133310", "K180653", "K070656", "K022735", "K991139", "K112181", "K925876", "K142429", "K150319", "K113457", "K012985", "K242582", "K871047", "K123377", "K951314", "K080666", "K901337", "K132317", "K151447", "K242154", "K001083", "K060625", "K032707", "K093358", "K071246", "K082739", "K203432", "K031578", "K242243", "K040694", "K050543", "K041551", "K071962", "K120686", "K113822", "K203625", "K042539", "K033372", "K153658", "K031168", "K103305", "K102672", "K160096", "K063254", "K251832", "K113412", "K120908", "K100454", "K080379", "K080967", "K222533", "K111451", "K002181", "K002056", "K132482", "K162999", "K090891", "K172390", "K080437", "K993418", "K042231", "K032619", "K252694", "K211344", "K053197", "K090357", "K260351", "K022427", "K132952", "K021494", "K963307", "K030475", "K173711", "K094018", "K153594", "K031049", "K170852", "K913312", "K033761", "K033813", "K233420", "K103355", "K161429", "K023089", "K151572", "K900723", "K060747", "K983483", "K063653", "K090001", "K073419", "K120274", "K891688", "K964021", "K052509", "K944354", "K151760", "K021914", "K991549", "K232955", "K051425", "K033836", "K103008", "K032542", "K192068", "K254221", "K083646", "K020033", "K112385", "K053160", "K173614", "K200030", "K131475", "K972881", "K212455", "K032872", "K161452", "K103758", "K042297", "K925523", "K160832", "K964367", "K123338", "K031852", "K093973", "K131948", "K051560", "K252700", "K913556", "K120850", "K070707", "K072173", "K960705", "K001678", "K062036", "K032590", "K091641", "K120330", "K093142", "K041649", "K210638", "K914866", "K112226", "K230284", "K162704", "K192955", "K030963", "K962503", "K171862", "K014041", "K082461", "K000651", "K012145", "K220040", "K140104", "K965174", "K032553", "K993415", "K022420", "K020434", "K032497", "K261772", "K030392", "K093919" ], "device_name": "Device, Neurovascular Embolization", "medical_specialty_description": "Neurology", "regulation_number": "882.5950", "device_class": "2", "registration_number": [ "3012536737", "", "2029275", "3016245399", "3013556777", "2134265", "1220477", "1225687", "3008853977", "2126666", "3008307705", "1721676", "3044156918", "2011171", "3007628272", "3013944123", "2133641", "3005168196", "3031550970", "2124215", "3012543881", "3003524171", "2032364", "2030598", "3013758550", "3008837339", "9616684", "3010178296", "3033589330", "3009380063", "3014644549", "3010079067", "3012931345", "3009761573", "3015453963", "1226348", "3010173425", "2022435", "3015531723", "3008881809", "3027595249", "3000143502", "3007738736", "3015615738", "3015550451", "3007029079", "9614654", "3016540856", "3014162263", "9615728", "3008264254", "3015309643", "3008824097", "3008114965", "2029214", "3017961114", "3006950086", "3002807295", "3013353964", "3016591327", "1820334", "3016609702", "1043729", "9617601" ], "fei_number": [ "3012536737", "", "3016245399", "3013556777", "3002913962", "3002534070", "1220477", "3008853977", "2126666", "3008307705", "1721676", "3002095335", "3044156918", "2011171", "3007628272", "3013944123", "3005168196", "3031550970", "1000220862", "2124215", "3012543881", "3003524171", "1000518731", "3013758550", "3008837339", "3033589330", "3002807036", "3009380063", "3014644549", "3003323921", "3010079067", "3012931345", "3009761573", "3015453963", "1000306431", "2022435", "3015531723", "3008881809", "1043729", "3027595249", "3000143502", "3007738736", "3015615738", "3015550451", "3002808904", "3016609702", "3016540856", "3014162263", "3002808761", "3008264254", "3015309643", "3008824097", "3002947440", "3008114965", "3017961114", "3006950086", "3002807295", "3013353964", "3016591327", "3000203466", "1820334", "3001451463", "3003110073", "3007029079" ] } } ] }