{
  "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": "131204",
      "product_res_number": "Z-0575-2015",
      "event_date_initiated": "2014-10-17",
      "event_date_posted": "2014-12-12",
      "recall_status": "Terminated",
      "event_date_terminated": "2015-04-16",
      "res_event_number": "69635",
      "product_code": "MRN",
      "k_numbers": [
        "K131686"
      ],
      "product_description": "INOMAX DSIR Nitric Oxide delivery system, Model 10007, software version 3.1.0., delivers INOMAX (nitric oxide for inhalation) therapy gas and provides continuous monitoring of inspired O2, NO2, and NO, and comprehensive alarm systems. The primary clinical settings are Neonatal Intensive Care Units (NICU) and to transport of neonates.",
      "code_info": "Serial Numbers:  DS20080152, DS20090925, DS20101076, DS20101499, DS20110886, DS20110965, DS20120099, DS20120150, DS20120169.",
      "firm_fei_number": "3004531588",
      "recalling_firm": "INO Therapeutics (dba Ikaria)",
      "address_1": "2902 Dairy Dr",
      "city": "Madison",
      "state": "WI",
      "postal_code": "53718-3809",
      "additional_info_contact": "Ikaria Customer Care\n877-566-9466",
      "reason_for_recall": "An issue has been identified in the INOmax DSIR system that could result in monitored Nitric Oxide (NO) concentration reporting lower than expected.  This issue only pertains to those devices manufactured using a specific version of the Monitoring Circuit Board.",
      "root_cause_description": "Process change control",
      "action": "Ikaria contacted consignees by phone beginning 10/17/2014.  \nA follow-up letter was sent to customers beginning 10/22/2014.  The letter described the issue, requested that affected devices not be used and to return to Ikaria.  Customers with questions can contact Ikaria Customer Care at 1-877-566-9466.",
      "product_quantity": "9",
      "distribution_pattern": "US Distribution in states of: VA and PA only.",
      "openfda": {
        "k_number": [
          "K240410",
          "K081691",
          "K242374",
          "K242578",
          "K171696",
          "K093922",
          "K222930",
          "K070867",
          "K233251",
          "K121021",
          "K080484",
          "K143213",
          "DEN000001",
          "K033779",
          "K130605",
          "K200389",
          "K212409",
          "K220898",
          "K120216",
          "K110635",
          "K093260",
          "K000186",
          "K061901",
          "K193481",
          "K113272",
          "K231823",
          "K131686",
          "K092545",
          "K201339",
          "K000653",
          "K110344",
          "K071516",
          "K211153"
        ],
        "device_name": "Apparatus, Nitric Oxide Delivery",
        "medical_specialty_description": "Anesthesiology",
        "regulation_number": "868.5165",
        "device_class": "2",
        "registration_number": [
          "3012796317",
          "1625392",
          "3019771924",
          "2133810",
          "2518435",
          "3012160128",
          "9611296",
          "3006897516",
          "3004531588",
          "3011193444",
          "3014527933"
        ],
        "fei_number": [
          "3002809568",
          "3012796317",
          "3019771924",
          "3000203066",
          "2518435",
          "3012160128",
          "3014074925",
          "3006897516",
          "3004531588",
          "1000058335",
          "3011193444"
        ]
      }
    }
  ]
}