{
  "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 II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "97554",
      "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": "E-Mail",
      "distribution_pattern": "US Nationwide distribution in the state of Minnesota.",
      "recall_number": "Z-0378-2026",
      "product_description": "Ivenix Infusion System (IIS), Large Volume Pump. Model Number: LVP-0004.",
      "product_quantity": "6 units",
      "reason_for_recall": "Potential issue that can cause the device to register \"phantom\" touches in the lower-left corner of the touchscreen during operation.",
      "recall_initiation_date": "20250903",
      "center_classification_date": "20251028",
      "report_date": "20251105",
      "code_info": "Model Number: LVP-0004. UDI-DI: 00811505030320. Serial Numbers: 2318600378, 2321600176, 2333300359, 2403001383, 9242756430, 9243097443."
    }
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}