{
  "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": "2026-08-15",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "49779",
      "product_res_number": "Z-0350-2007",
      "event_date_initiated": "2006-11-10",
      "event_date_posted": "2007-01-25",
      "recall_status": "Terminated",
      "event_date_terminated": "2007-02-05",
      "res_event_number": "37023",
      "product_code": "DWC",
      "k_numbers": [
        "K031544"
      ],
      "product_description": "Jostra Heater Cooler Unit HCU30, system version 1.02-Low voltage machine",
      "code_info": "Article number: 0704629 Serial numbers: 101006, 101007, 101008, 101009, 101010, 101011, 101013, 101015, 101016, 101018, 101019, 101020, 101022, 101023, 101024.",
      "firm_fei_number": "3008355164",
      "recalling_firm": "MAQUET Inc.",
      "address_1": "1140 US Highway 22",
      "city": "Bridgewater",
      "state": "NJ",
      "postal_code": "08807-2958",
      "additional_info_contact": "Jamie Yieh\n908-947-2311",
      "reason_for_recall": "The HCU 30 system potentially will not be have the power capacity  to run the compressor when the heaters are on during operation. This may lead to a situation where the user may not be able to cool the patient and/or cardioplegia sufficiently.",
      "root_cause_description": "Other",
      "action": "Letters were mailed to customers on 11/10/2006 by Federal Express.",
      "product_quantity": "13 units",
      "distribution_pattern": "Hospitals in CA, NC, FL, WY, NY and WV.S",
      "openfda": {
        "k_number": [
          "K893940",
          "K031544",
          "K130300",
          "K873699",
          "K191402",
          "K001520",
          "K874927",
          "K896393",
          "K071521",
          "K873924",
          "K822874",
          "K122813",
          "K945720",
          "K003145",
          "K883603",
          "K896974",
          "K014016",
          "K212657",
          "K896975",
          "K896972",
          "K896973",
          "K140012",
          "K220635",
          "K810647",
          "K896971",
          "K873813",
          "K841402",
          "K052601",
          "K831677",
          "K102147"
        ],
        "registration_number": [
          "3001588119",
          "1723241",
          "3006073153",
          "9611109",
          "1828100",
          "1516825",
          "1928237",
          "1720929",
          "3007899424",
          "1649914"
        ],
        "fei_number": [
          "1000517719",
          "3001588119",
          "3006073153",
          "1828100",
          "1516825",
          "3002808267",
          "1720929",
          "3007899424",
          "3001665800",
          "1928237"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}