{
  "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": "104616",
      "product_res_number": "Z-0341-2012",
      "event_date_initiated": "2011-09-27",
      "event_date_posted": "2011-12-01",
      "recall_status": "Terminated",
      "event_date_terminated": "2012-02-19",
      "res_event_number": "60153",
      "product_code": "LKD",
      "k_numbers": [
        "K043003"
      ],
      "product_description": "TC pCO2 Electrodes, Model/Part  #945-655-E5260, 510(k) #K043003.  \n\nProduct Usage:  The device is intended for  used with the firm's TCM series monitor.  The E260mpCO2 electrode is a non-invasive device, used with the TCM series monitor to measure transcutaneous pCO2 (through the skin).",
      "code_info": "Part Number:  945-655, Lot Code:  DP-06",
      "firm_fei_number": "1523456",
      "recalling_firm": "Radiometer America Inc",
      "address_1": "810 Sharon Dr",
      "city": "Westlake",
      "state": "OH",
      "postal_code": "44145-1521",
      "additional_info_contact": "James Gibbons\n440-871-8900 Ext. 53489",
      "reason_for_recall": "Transcutaneous pCO2-electrodes were wrongly coded as:  pO2 electrode on the hardware plug for the firm's TCM series monitors.  This causes the monitor to interpret the electrode wrongly, causing it to fail all calibrations and never get ready for use.",
      "root_cause_description": "Employee error",
      "action": "Radiometer contacted the affected U.S. customer and informed them of the recall via telephone on September 27, 2011. Radiometer requested the return of the affected product received from the firm. For questions call (440) 871-0463.",
      "product_quantity": "4 units were distributed.",
      "distribution_pattern": "Worldwide Distribution - USA (nationwide) in the state of San Diego, CA.",
      "openfda": {
        "k_number": [
          "K041548",
          "K913013",
          "K131253",
          "K990960",
          "K980756",
          "K232516",
          "K890517",
          "K043357",
          "K905225",
          "K093154",
          "K151329",
          "K110474",
          "K900333",
          "K043003",
          "K101690",
          "K891481",
          "K883606"
        ],
        "pma_number": [
          "P820025",
          "P850087",
          "P810037",
          "P840037",
          "P810022",
          "P830008",
          "P800043",
          "P820019"
        ],
        "registration_number": [
          "3012528160",
          "3009077524",
          "9614470",
          "3016701404",
          "3000126629",
          "9610816",
          "3013513377",
          "3003263092",
          "3012409105",
          "3004149774",
          "3013596024",
          "3016618143",
          "3002807968",
          "3013500228",
          "3007490412",
          "2020676",
          "3012866928",
          "8030885"
        ],
        "fei_number": [
          "3002663379",
          "3012528160",
          "3009077524",
          "3016701404",
          "3003244961",
          "3000126629",
          "3013513377",
          "3003263092",
          "3012409105",
          "3004149774",
          "3013596024",
          "3016618143",
          "3002807968",
          "3013500228",
          "3007490412",
          "2020676",
          "3012866928",
          "3002807167"
        ],
        "device_name": "Monitor, Carbon-Dioxide, Cutaneous",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.2480",
        "device_class": "2"
      }
    }
  ]
}