{
  "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": "Ongoing",
      "city": "North Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "92973",
      "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": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "distribution_pattern": "US Nationwide distribution in the states of NJ, WI.",
      "recall_number": "Z-2635-2023",
      "product_description": "Ivenix Infusion System (IIS), Large Volume Pump (LVP) Software: 5.0.0 and 5.0.1  Part Number: LVP-SW-0004.     Indicated for use in a hospital and in outpatient care environments for the controlled administration of fluids through clinically accepted routes of administration.",
      "product_quantity": "1344 pumps",
      "reason_for_recall": "Start-up time for the flow rate range greater than 50 ml/hr, and less than 200 ml/hr may exceed the specified 6 minutes, depending on the characteristics of air bubble entrapment within the Intermediate Pumping Chamber (IPC) of the administration set",
      "recall_initiation_date": "20220422",
      "center_classification_date": "20230925",
      "report_date": "20231004",
      "code_info": "(UDI): 00811505030122 Software Version: 5.0.0 and 5.0.1"
    }
  ]
}