{
  "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": "2026-07-08",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "North Andover",
      "state": "MA",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97941",
      "recalling_firm": "Fresenius Kabi USA, LLC",
      "address_1": "50 High St Ste 50",
      "address_2": "",
      "postal_code": "01845-2620",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the states of IL, MD, MI, OK, SC, TX, VA & WI.",
      "recall_number": "Z-0586-2026",
      "product_description": "IVENIX INFUSION SYSTEM, LVP Primary Administration Set, Dual-Inlet, Low-Sorbing, Needle-Free Port, Dual Y-Site (Qty 25). Large Volume Infusion Pump Administration Set.",
      "product_quantity": "483 cases (12,075 eaches)",
      "reason_for_recall": "Incorrect assembly of specific lot of LVP Primary Administration Set that could result in serious patient injury.",
      "recall_initiation_date": "20251103",
      "center_classification_date": "20251203",
      "report_date": "20251210",
      "code_info": "Product Code: SET-0032-25; UDI: 00811505030214; Lot No. FA25B03126.",
      "more_code_info": ""
    }
  ]
}