{
  "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": "2026-08-20",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "73624",
      "product_res_number": "Z-0462-2009",
      "event_date_initiated": "2008-09-20",
      "event_date_posted": "2008-12-29",
      "recall_status": "Terminated",
      "event_date_terminated": "2010-08-05",
      "res_event_number": "49495",
      "product_code": "KZD",
      "k_numbers": [
        "K893519"
      ],
      "product_description": "CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve\nModel: 803FGA.  It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices.",
      "code_info": "Lot Numbers: 30241308, 22710808, 22720808, 22730808, 23300808, 34391608, \t40042008, 41082108, 41752108, 42422208, 44742408, and 45612508.",
      "firm_fei_number": "2244861",
      "recalling_firm": "CAS Medical Systems, Inc.",
      "address_1": "44 E Industrial Rd",
      "city": "Branford",
      "state": "CT",
      "postal_code": "06405",
      "additional_info_contact": "SAME\n203-488-6056",
      "reason_for_recall": "Leaks: Infusion Cuffs may exhibit air leakage at the union of  the tube and bag, and not maintain pressure.  For further information, please contact the firm at 203-488-6056.",
      "root_cause_description": "Equipment maintenance",
      "action": "CAS Medical Systems notified accounts by letter dated 9/19/08 requesting return  and sub-recall be conducted to their accounts.  The letter was entitled \"UNIFUSOR(R) INFUSION CUFFS AND PRIVATE LABEL (CASMED-MANUFACTURED) INFUSION CUFFS *** URGENT PRODUCT CORRECTION NOTICE.\"  For further information, please contact the firm at 203-488-6056.",
      "product_quantity": "5,977 pc.",
      "distribution_pattern": "Nationwide\nForeign: Malaysia, Austria, Belgium, Czech Rep., France, Germany, Greece, Italy, Norway, Spain, Sweden, Switzerland and the UK.",
      "openfda": {
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        "device_name": "Infusor, Pressure, For I.V. Bags",
        "medical_specialty_description": "General Hospital",
        "regulation_number": "880.5420",
        "device_class": "1"
      }
    }
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}