{
  "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": "2026-04-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Lake Forest",
      "state": "IL",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "78312",
      "recalling_firm": "ICU Medical Inc",
      "address_1": "600 N Field Dr",
      "address_2": "N/A",
      "postal_code": "60045-4835",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Distribution was nationwide to medical facilities.  Foreign distribution was made to Canada and Australia.  Government and military distribution was also made.",
      "recall_number": "Z-0101-2018",
      "product_description": "Plum 360 Infusion System, List number 30010.",
      "product_quantity": "21,461 devices",
      "reason_for_recall": "(1) Under certain conditions, if a malfunction alarm occurs while the pump is in the \"Paused\" state waiting for the distal pressure to decrease, the pump cannot be turned off and delivery cannot be restarted until the battery is discharged or is disconnected; and (2) when the user accesses the Preventive Maintenance Screen in Service/Biomed Mode with a Total Delivery Time >1,500 hours, the user will not be able to interact with the device and the device must be power cycled.",
      "recall_initiation_date": "20171030",
      "center_classification_date": "20171116",
      "termination_date": "20190828",
      "report_date": "20171122",
      "code_info": "All devices with software v15.10.00.010"
    }
  ]
}