{
  "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": "106250",
      "product_res_number": "Z-0856-2012",
      "event_date_initiated": "2011-03-31",
      "event_date_posted": "2012-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-01-26",
      "res_event_number": "60701",
      "product_code": "MLN",
      "k_numbers": [
        "K964469"
      ],
      "product_description": "R2 Adult R2 Non-Radiolucent Multifunction Electrodes, Catalog/REF No. 3200-1715, NON-STERILE, MADE IN USA, CONMED CORPORATION, 525 FRENCH ROAD, UTICA, NY 13507\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 1010194",
      "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\n315-797-8375",
      "reason_for_recall": "The specific lot was assembled without the rivet cover.",
      "root_cause_description": "Employee error",
      "action": "ConMed Corporation sent a Urgent Medical Device Recall Letter dated March 25, 2011, to all affected customers.  The letter identified the product the problem and the action needed to be taken by the customer.\n\nCustomers were instructed to immediately stop use of the device and return it to ConMed Corporation. Please review your inventory for any of the devices listed on Attachment I.  If you do not have any devices to return, please follow the instructions in the letter and complete Attachment II, indicating you have no devices and fax it to 315-624-3225.  Please complete the attached Business reply form.  \n\nWe apologize for any inconvenience this will cause you or your staff.\n\nFor further questions please call (315) 797-8375.",
      "product_quantity": "850 sets (2 pads per set in individual pouch)",
      "distribution_pattern": "Worldwide Distribution --  USA (nationwide) and the countries of  Canada, Belgium, Germany and Hong Kong.",
      "openfda": {
        "registration_number": [
          "3043138885",
          "3009482034",
          "3027645317",
          "2022388",
          "3012494290",
          "3007048259",
          "3043088937",
          "3043226252",
          "3014739961",
          "3012606445",
          "1219103",
          "1423537",
          "3022320321",
          "3022298579",
          "3010131137",
          "1930027",
          "3007184699",
          "9681860",
          "3009883402",
          "8020045",
          "1921846",
          "3013791928"
        ],
        "fei_number": [
          "3043138885",
          "3009482034",
          "3027645317",
          "2022388",
          "3012494290",
          "3001236905",
          "3007048259",
          "3043088937",
          "3043226252",
          "3014739961",
          "6736",
          "3012606445",
          "3022320321",
          "3022298579",
          "3010131137",
          "1930027",
          "3003491392",
          "3007184699",
          "3009883402",
          "1921846",
          "1000148701",
          "3013791928"
        ],
        "device_name": "Electrode, Electrocardiograph, Multi-Function",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.2360",
        "device_class": "2"
      }
    }
  ]
}