{ "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": "2026-08-20", "results": { "skip": 0, "limit": 1, "total": 1 } }, "results": [ { "cfres_id": "131464", "product_res_number": "Z-0454-2015", "event_date_initiated": "2014-11-06", "event_date_posted": "2014-12-04", "recall_status": "Terminated", "event_date_terminated": "2017-10-30", "res_event_number": "69752", "product_code": "MKJ", "k_numbers": [ "K014209" ], "product_description": "ADULT Radiotransparent Electrode, REF/Catalog Number 2001H, Rx ONLY --- COMPARABLE TO PHILIPS MEDICAL HEARTSTART ELECTRODES PLUG STYLE CONNECTOR\nIntended for use during defibrillation, cardioversion, pacing, and ECG monitoring applications. This product is a single-use, disposable device.", "code_info": "All Lot Codes", "firm_fei_number": "3001451571", "recalling_firm": "ConMed Corporation", "address_1": "525 French Rd", "city": "Utica", "state": "NY", "postal_code": "13502-5945", "additional_info_contact": "Gregory Connell\n727-399-5276", "reason_for_recall": "Philips Healthcare made changes to the design of the connection between multifunction electrodes and their HeartStart FR3 and HeartStart FRx AEDs. The failure to connect may result in a delay of therapy, which could result in patient death or serious injury.", "root_cause_description": "Device Design", "action": "ConMed sent an Urgent Device Correction letter dated November 16, 2014, to all affected consignees via UPS Next Day Air. The letter instructed consignees to notify all end users of the correction. For questions or additional information, consignees were instructed to contact ConMed at 1-727-399-5276 or by e-mail at multifunctionelectrodes@conmed.com. International notices were sent via UPS Priority or equivalent by November 19, 2014.", "product_quantity": "174,610 (168,090 US and 6,520 OUS) in total.", "distribution_pattern": "Worldwide Distribution - USA (nationwide) Puerto Rico, and Internationally to Bosnia, Herzegovina, Brazil, Canada, Great Britain, Israel, Italy, Republic of Korea, Norway, Portugal, Saudi Arabia, and Spain.", "openfda": { "k_number": [ "K032439", "K971148", "K896919", "K992543", "K860676", "K983393", "K003565", "K040256", "K091561", "K031187", "K853564", "K030898", "K011144", "K103567", "K953204", "K955628", "K120406", "K111594", "K012766", "K002232", "K133484", "K150055", "K120536", "K993036", "K122600", "K020984", "K033771", "K993072", "K120907", "K060934", "K072430", "K110825", "K063510", "K041067", "K111693", "K130684", "K010214", "K063119", "K091265", "K123881", "K962359", "K932931", "K062177", "K942850", "K092598", "K943698", "K002445", "K142430", "K143714", "K955923", "K080421", "K040438", "K120350", 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