{
  "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": "2026-04-01",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Ongoing",
      "city": "Minneapolis",
      "state": "MN",
      "country": "United States",
      "classification": "Class I",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "88455",
      "recalling_firm": "Smiths Medical ASD Inc.",
      "address_1": "6000 Nathan Ln N",
      "address_2": "N/A",
      "postal_code": "55442-1690",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "US Nationwide Distribution and PR    OUS distribution in - Austria, Australia, Belgium, Switzerland, Canada, Germany, Spain, Finland, France, United Kingdom, Greece, Hong Kong, Hungary, Ireland, Italy, Kuwait, Luxembourg, Netherlands, New Zealand, Panama, Poland, Portugal, Sweden, Turkey, Venezuela, South Africa",
      "recall_number": "Z-2377-2021",
      "product_description": "NORMOFLO Irrigation Warming administration set (disposable), Models IR-40, IR-500, IR-600, IRI-600, IRI-600B, IR-700",
      "product_quantity": "519,250",
      "reason_for_recall": "There is potential for harmful levels of aluminum leaching when using lower flow rates with certain solutions and blood products and longer duration of use.",
      "recall_initiation_date": "20210806",
      "center_classification_date": "20210903",
      "report_date": "20210915",
      "code_info": "Model IR-40: Product Code IR-40      Model IR-500: Product Code IR-500      Model IR-600: Product Code IR-600      Model IRI-600: Product Code IRI-600      Model IRI-600B: Product Code IRI-600B      Model IR-700: Product Code IR-700",
      "more_code_info": ""
    }
  ]
}