{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Saint Paul",
      "state": "MN",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "76190",
      "recalling_firm": "Smiths Medical ASD, Inc.",
      "address_1": "1265 Grey Fox Rd",
      "address_2": "N/A",
      "postal_code": "55112-6929",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Visit",
      "distribution_pattern": "Distribution in the foreign country of Sweden",
      "recall_number": "Z-1105-2017",
      "product_description": "NORMFlow H-110 Irrigation Fluid Warmer, Continental Europe, Model H-1100, Reorder H-1100-INT-230.    Product  Usage:  NORMOFLO¿ H-1100 Irrigation Fluid Warmers has been designed for safe, in-line warming of irrigating fluids as they are administered to patients. The Fluid Warmer utilizes a solution reservoir housed in a controller unit (warmer). The recirculation solution is heated to present temperature in the reservoir, pumped though a heat exchanger ( a component of the Sets) and is returned to the reservoir for continuous recirculation. The NORMOFLO Warming products are typically used in clinical situations that may require rapid irrigation with warmed fluids.",
      "product_quantity": "1",
      "reason_for_recall": "Smiths Medical became aware that that one (1) NORMOFLO¿ H-1100 Irrigation Fluid Warmers was incorrectly labelled with Spanish language labels instead of English labels.   Specifically five (5) labels were incorrect; the Operator\u0019s Manual, Outer Base Box label, Pole Assembly Box label, and two (2) O-ring Lube labels.",
      "recall_initiation_date": "20161025",
      "center_classification_date": "20170126",
      "termination_date": "20170725",
      "report_date": "20170201",
      "code_info": "S105B0061"
    }
  ]
}