{
  "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": "50079",
      "product_res_number": "Z-0503-2007",
      "event_date_initiated": "2007-01-01",
      "event_date_posted": "2007-02-15",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-06-22",
      "res_event_number": "37192",
      "product_code": "NCX",
      "k_numbers": [
        "K014241"
      ],
      "product_description": "Alsius Cool Line Catheter, Model CL-2295AE",
      "code_info": "Lot numbers: 16243 & 16292",
      "firm_fei_number": "3002922896",
      "recalling_firm": "Alsius Corporation",
      "address_1": "15770 Laguna Canyon Rd Ste 150 15770 Laguna Canyon Rd",
      "address_2": "Ste 150",
      "city": "Irvine",
      "state": "CA",
      "postal_code": "92618-3111",
      "additional_info_contact": "Dr. Kenneth Collins\n949-453-0150",
      "reason_for_recall": "Testing by Alsius has identified that 6-10% of catheters from the three affected lots may exhibit a significant reduction in their heat exchange capacity.",
      "root_cause_description": "Other",
      "action": "Customer letters were sent starting January 1, 2006 via FEDEX and DHL.  Verification of receipt of the notification letter to level A will be undertaken by using tracked delivery requiring signature upon receipt .  The Customer letters will notify consignees of the nature of the problem and provide instructions to return the product.",
      "product_quantity": "125",
      "distribution_pattern": "Worldwide including USA, Austria, Canada, France, Greece, Japan, Norway, Spain & Switzerland",
      "openfda": {
        "k_number": [
          "K014241",
          "K071008",
          "K213031",
          "K081936",
          "K022366",
          "K063829",
          "K030421",
          "K080899",
          "K051912",
          "K152946",
          "K150046",
          "K052443",
          "K080908",
          "K033623",
          "K223746",
          "K070161",
          "K153226",
          "K012512",
          "K141139",
          "K153162",
          "K063405",
          "K220008",
          "K101987",
          "K072234",
          "K071358",
          "K060308"
        ],
        "registration_number": [
          "2024311",
          "2029275",
          "3010617000",
          "3029871637"
        ],
        "fei_number": [
          "3029871637",
          "2024311",
          "3003793491",
          "1000306431"
        ],
        "device_name": "System, Hypothermia, Intravenous, Cooling",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.5900",
        "device_class": "2"
      }
    }
  ]
}