{
  "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,
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  "results": [
    {
      "cfres_id": "196036",
      "product_res_number": "Z-0002-2023",
      "event_date_initiated": "2022-09-08",
      "event_date_posted": "2022-10-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2024-09-10",
      "res_event_number": "90845",
      "product_code": "PHC",
      "k_numbers": [
        "K183311"
      ],
      "product_description": "Ivenix Infusion System (IIS), LVP Software; LVP-SW-0004\n\nversion 5.2.0",
      "code_info": "UDI-DI: 00811505030122 \n\nversion 5.2.0",
      "firm_fei_number": "3014732157",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "50 High St Ste 50 50 High St",
      "address_2": "Ste 50",
      "city": "North Andover",
      "state": "MA",
      "postal_code": "01845-2620",
      "additional_info_contact": "Matt Kuhn\n847-550-5751",
      "reason_for_recall": "The display screen may become frozen and unresponsive to user input, triggering an alarm that is evidenced by a buzzer sound and flashing red LEDs as a secondary notification. However, as the screen goes blank it does not indicate an alarm condition or respond. This issue leads to temporary cessation of flow of a medication or fluid, requiring immediate intervention by the clinician.",
      "root_cause_description": "Software design",
      "action": "On September 8, 2022, the company notified affected customers via phone call and emailed letter. Customers were instructed to do the following:\n\n1. If a high priority Pump Problem alarm occurs, the LVP should be powered down by holding the power button for 10 seconds then releasing the power button so that the screen goes dark, then pressing the power button again to re-start the pump. Alternatively, if you have another LVP available, you may use it to resume infusion.\n\n2. Inform potential users of the product within your organization of this notification. If your facility further distributes or transfers products amongst satellite sites or other locations, please disseminate this information accordingly.\n\nFresenius Kabi has updated the software to rectify the condition. The updated software is currently available. Please schedule a service call at your earliest convenience to have it installed.\n\nCustomer support: Ivenix_support@fresenius-kabi.com; 1-978-775-8100",
      "product_quantity": "4 instances",
      "distribution_pattern": "Domestic distribution to NJ and WI.",
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        "device_name": "Infusion Safety Management Software",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5725",
        "device_class": "2"
      }
    }
  ]
}