{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Madison",
      "state": "WI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "75878",
      "recalling_firm": "INO Therapeutics (dba Ikaria)",
      "address_1": "6603 Femrite Dr",
      "address_2": "N/A",
      "postal_code": "53718-6801",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Distribution to the states of : CA, CO, DC, FL, GA, HI, IA, IL, IN, MI, MN, NC, NJ, NM, NY, OH, PA, and TX",
      "recall_number": "Z-1076-2017",
      "product_description": "Mallinckrodt Pharmaceuticals INOmax DSIR Plus delivery system.  Model 10007.  Delivers INOMAX (nitric oxide for inhalation).    The INOmax DSIR uses a \u001cdual-channel\u001d design to ensure the safe delivery of INOMAX.  The first channel has the delivery CPU, the flow controller and the injector module to ensure the accurate delivery of NO.  The second channel is the monitoring system, which includes a separate monitor CPU, the gas cells (NO, NO2, and 02 cells) and the user interface including the display and alarms.  The dual-channel approach to delivery and monitoring permits INOMAX delivery independent of monitoring but also allows the monitoring system to shutdown INOMAX delivery if it detects a fault in the delivery system such that the NO concentration could become greater than 100 ppm.  The delivery system can also shut down delivery if it detects certain serious problems with the monitoring system.",
      "product_quantity": "45",
      "reason_for_recall": "Mallinckrodt discovered that some devices may have been manufactured with an out-of-tolerance manometer which can result in in an inaccurate proportional valve calibration table in an affected device.",
      "recall_initiation_date": "20161121",
      "center_classification_date": "20170123",
      "termination_date": "20171220",
      "report_date": "20170201",
      "code_info": "Serial Numbers:  DS20070030, DS20070043, DS20070094, DS20070268, DS20090096, DS20090458, DS20090484, DS20090539, DS20090620, DS20090645, DS20100071, DS20100118, DS20100216, DS20100266, DS20100268, DS20100330, DS20100439, DS20100496, DS20100604, DS20100675, DS20100744, DS20100762, DS20100950, DS20101199, DS20101337, DS20101359, DS20101369, DS20101406, DS20101443, DS20101524, DS20110242, DS20110480, DS20110577, DS20110849, DS20110868, DS20110912, DS20110915, DS20110972, DS20110976, DS20110990, DS20120008, DS20120161, DS20120266, DS20120281, DS20120370."
    }
  ]
}