{
  "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": "2026-03-18",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Completed",
      "city": "North Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "93958",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "50 High St Ste 50",
      "address_2": "N/A",
      "postal_code": "01845-2620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Other",
      "distribution_pattern": "US Nationwide distribution in the states of WI and NJ.",
      "recall_number": "Z-1282-2024",
      "product_description": "LVP software of the Ivenix Infusion System (IIS), LVP-SW-0004",
      "product_quantity": "3",
      "reason_for_recall": "Retroactively reported correction from 2022: A software defect may cause an incorrect (Fail-Stop) Alarm when an administration set is loaded with an upstream occlusion present, resulting in a non-recoverable (Fail-Stop) Pump Problem alarm. This may lead to delay of therapy, and patient may experience from no to minimal to serious harm.    This issue was resolved in all fielded product in software version 5.2.1, which was installed in September 2022.",
      "recall_initiation_date": "20220916",
      "center_classification_date": "20240311",
      "report_date": "20240320",
      "code_info": "UDI-DI 00811505030122 Software versions 5.0.1 and earlier."
    }
  ]
}