{ "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": "2026-09-17", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "195570", "product_res_number": "Z-1680-2022", "event_date_initiated": "2022-07-26", "event_date_created": "2022-09-06", "recall_status": "Open, Classified", "res_event_number": "90724", "product_code": "HCG", "k_numbers": [ "K172390", "K200030" ], "product_description": "Optima Coil System Model OPTI0520CSF10. For endovascular embolization.", "code_info": "Model Number: OPTI0520CSF10\nUDI-DI Code: 00818053026164\nLot Number: F220600470", "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": "Products were released to customers prior to the approval and release of a test report authorizing the use of an existing material from an alternate supplier.", "root_cause_description": "Under Investigation by firm", "action": "On or about 07/15/2022, Balt USA LLC communicated an \"URGENT FIELD SAFETY NOTICE (FSN)/PRODUCT RECALL\" Letter informing customers that Balt became aware that finished goods were released and distributed to customers prior to the approval and release of a test report authorizing the use of existing material from an alternate supplier. On 08/08/2022 and updated/revised \"URGENT MEDICAL DEVICE RECALL\" letter was sent via certified mail to customers re-emphasizing the recall and providing updated instructions\n\nCustomer are instructed to:\n-Inform within their hospital safety officers, pharmacists, head of neuroradiology and the neuroradiology department staff, as well as any other person.\n\n-Return to Balt USA any unused product from lot #F220600470:\n+Collect and put in quarantine the Optima products concerned by this recall and then return them to Balt USA through the usual \"RMA\" (Return Material Authorization) procedure by contacting Balt USA's Customer Service Department\n+Keepj informed Balt USA about the status of every unit of Optima products concerned by this recall;\n+Fulfill the \"Notice of receipt\" then return to Balt USA via the indicated contact.\n\n-If product from lot #F220600470 has been used, no further action is required. \n\nFor question contact - Quality Department at QA@baltgoup.com or telephone number 949-788-1443 or Fax Number: 949-788-1444", "product_quantity": "4 devices", "distribution_pattern": "U.S.: AZ and FL\n\nO.U.S.: None", "openfda": { "k_number": [ "K002181", "K161452", "K032542", "K022420", "K000651", "K151572", "K021914", "K172390", "K103355", "K083646", "K093973", "K060625", "K972881", "K153658", "K032590", "K123338", "K093358", "K053197", "K102672", "K180653", "K993418", "K100454", "K022427", "K143218", "K162999", "K010026", "K103008", "K073419", "K171747", "K022735", "K080437", "K192955", "K171862", "K170852", "K913312", "K033372", "K251832", "K983483", "K112181", "K031852", "K963307", "K093919", "K002056", "K030392", "K160832", "K012145", "K123377", "K120908", "K120850", "K900723", "K041551", "K891688", "K173711", "K112226", "K222533", "K070656", "K071962", "K911779", "K961923", "K131948", "K091641", "K901721", "K242243", "K113412", "K093142", "K230284", "K960705", "K914866", "K042231", "K871047", "K051560", "K142513", "K913556", "K964021", 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