{
  "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": "93968",
      "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 to the states of CA, CO, NJ, WI, UT.",
      "recall_number": "Z-1283-2024",
      "product_description": "LVP software of the Ivenix Infusion System (IIS); LVP-SW-0004",
      "product_quantity": "6 US",
      "reason_for_recall": "Retroactively reported corrections from 2023: 1) A software defect may cause an incorrect (Fail-Stop) alarm when an administration set is loaded or coupled while the pump is executing the power-up sequence. May lead to delay in therapy. 2) Alert is not annunciated informing the clinician that the bolus cannot be delivered when the entered bolus dose exceeds the Care Profile Hard Rate Max limit and Rapid Bolus is selected. May lead to over infusion. Both issues were resolved in all fielded product in software version 5.8.0, which was installed in affected units May thru August 2023.",
      "recall_initiation_date": "20230510",
      "center_classification_date": "20240311",
      "report_date": "20240320",
      "code_info": "UDI-DI 00811505030122 Software versions 5.2.1/5.2.2"
    }
  ]
}