{ "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": "106249", "product_res_number": "Z-0735-2012", "event_date_initiated": "2011-03-09", "event_date_posted": "2012-01-12", "recall_status": "Terminated", "event_date_terminated": "2012-01-12", "res_event_number": "60700", "product_code": "LDD", "k_numbers": [ "K964469" ], "product_description": "R2 Adult Zoll Non-Radiolucent Multifunction Electrodes, Catalog/REF 3111-1721, NON-STERILE, ASSEMBLED IN MEXICO, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13505.\n\nThis device, when connected to a monitor/defibrillator has the ability to monitor the electro-cardio function (ECG) of the patient. The device, when electrically activated by the monitor/defibrillator can pace the heart rate of the patient and may also transmit the electrical current to the patient for cardio-conversion. This is a non-sterile, disposable device.", "code_info": "Lot 1006284", "firm_fei_number": "3001451571", "recalling_firm": "ConMed Corporation", "address_1": "525 French Road", "city": "Utica", "state": "NY", "postal_code": "13502", "additional_info_contact": "M. Patricia Cotter\n315-624-3533", "reason_for_recall": "The product lot was assembled with an R2 Connector, rather than a Zoll Connector.", "root_cause_description": "Packaging process control", "action": "ConMed Corporation sent an \"URGENT: DEVICE RECALL\" letter dated March 9, 2011 to all affected customers. The letter describes the product, problem, and actions to be taken by the customers. The letter instructs customers to review their inventory for the affected product and to stop use of the devices immediately. A Business Reply Form was attached for customers to complete and return to the firm via fax to 315-624-3225. Additionally, instructions were provided on how to return the affected devices. Contact the ConMed Recall Coordinator at 315-624-3237 for questions regarding this notice.", "product_quantity": "190 sets (2 pads per set in individual pouch)", "distribution_pattern": "Nationwide Distribution-including the states of AZ, CA, IN, and MI.", "openfda": { "k_number": [ "K962551", "K801544", "K931787", "K780416", "K800936", "K852799", "K032691", "K912966", "K103159", "K842667", "K904462", "K140502", "K911402", "K910634", "K081442", "K923297", "K823931", "K831056", "K971355", "K930548", "K911455", "K921666", "K844103", "K823268", "K935111", "K813471", "K823933", "K842312", "K844447", "K882337", "K911456", "K903018", "K922173", "K914458", "K971194", "K910144", "K851092", "K874697", "K911662", "K951110", "K993205", "K905510", "K854175", "K853439", "K081574", "K871224", "K964469", "K922227", "K850618", "K103783", "K893990", "K982896", "K810237", "K922315", "K913484", "K150349", "K811638", "K921487", "K822294", "K882235", "K894355", "K895379", "K843229", "K971436", "K872793", "K921606", "K855082", "K012274", "K934508", "K842624", "K851485", "K103651", "K914971", "K911604", "K896903", "K935674", "K800937", "K863404", "K203231", "K921765", "K931803", "K851931", "K963781", "K854307", "K902478", "K923864", "K952085", "K941995", "K883617", "K902590", "K905065", "K920086", "K842235", "K895113", "K895032", "K910754", "K922563", "K042302", "K931053", "K812519", "K893403", "K885186", "K100654", "K200849", "K895651", "K871136", "K840258", "K102468", "K853354", "K895185", "K931805", "K903657", "K833751", "K890079", "K935083", "K931804", "K812520", "K880575", "K904466", "K894356", "K852808", "K832833", "K900169", "K922172", "K970481", "K912587", "K895533", "K822961", "K822617", "K103334", "K863303", "K902288", "K881153", "K812317", "K030417", "K931266", "K840246", "K934015", "K895009", "K182503", "K011461", "K840900", "K832827", "K823828", "K831696", "K891122", "K812586", "K781678", "K840167", "K851924", "K911665", "K874091", "K844740", "K874204", "K902782", "K863405", "K863899", "K940842", "K871135", "K843396", "K912621", "K864257", "K920990", "K902429", "K852905", "K895662" ], "registration_number": [ "3007029079", "1220908", "3010783192", "3003800159", "3010703925", "3017422354", "3015997711", "2183890", "3004035727", "3005521864", "1317188", "3012104670", "1417592", "3000126629", "3003615065", "3013500228", "8030978", "3004906872", "3003072803", "3011823740", "2246340", "1066270", "3005677568", "3013596024", "3008717264", "1930027", "3010317211", "3013826848", "3030677", "3000143502", "3009077524", "3007305485", "1320894", "3003832357", "3013557562", "1223925", "3014579161", "3015876" ], "fei_number": [ "3007029079", "1220908", "3010783192", "3003800159", "3010703925", "3017422354", "3015997711", "2183890", "3004035727", "3005521864", "1317188", "3012104670", "1417592", "3000126629", "3003615065", "3013500228", "3004906872", "3003072803", "3011823740", "2246340", "1000305720", "3005677568", "3013596024", "3008717264", "1930027", "3010317211", "3013826848", "3002808182", "3000143502", "3009077524", "3007305485", "3000957797", "3003832357", "3013557562", "3014579161", "1000524572", "3001451571", "3015876" ], "device_name": "Dc-Defibrillator, Low-Energy, (Including Paddles)", "medical_specialty_description": "Cardiovascular", "regulation_number": "870.5300", "device_class": "2" } } ] }