{
  "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
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  },
  "results": [
    {
      "cfres_id": "149889",
      "product_res_number": "Z-0348-2017",
      "event_date_initiated": "2016-09-27",
      "event_date_created": "2016-11-03",
      "recall_status": "Terminated",
      "event_date_terminated": "2019-08-19",
      "res_event_number": "75271",
      "product_code": "DWC",
      "k_numbers": [
        "K031544"
      ],
      "product_description": "Heater Cooler Unit\n\nUsage:\nThe Heater-Cooler Unit (HCU 30) supplies temperature-controlled water for cardioplegia heat exchangers and for blood heat exchangers in extra corporeal circulation and for blankets with which patients can be warmed or cooled. The HCU 30 is intended to circulate water through heat exchange circuits to warm or cool a patient during short duration cardiopulmonary bypass procedures lasting 6 hours or less.",
      "code_info": "HCU 30 Base Unit 100-120 V, Model Number 704629 I 70103.4371 HCU 30 Base Unit Canadian/US, Model Number 705501 I 70103.4653 HCU 30 Base Unit 200-240 V, Model Number 939001 I 70102.8718 All serial numbers are affected.",
      "firm_fei_number": "3008355164",
      "recalling_firm": "Maquet Cardiovascular Us Sales, Llc",
      "address_1": "45 Barbour Pond Dr",
      "city": "Wayne",
      "state": "NJ",
      "postal_code": "07470-2094",
      "additional_info_contact": "Ms. Mary Lou Insinga \n973-709-7000",
      "reason_for_recall": "There is the potential for contaminated water to enter parts of the Heater-Cooler Unit circuits. There is a potential risk of bacterial contamination including Mycobacteria species.",
      "root_cause_description": "Device Design",
      "action": "Maquet issued an Urgent Medical Device Recall letter/Return Response form dated September 27, 2016 to affected customers.  The letter identified the affected product, problem and actions to be taken.  Customer were instructed to complete the return response form via fax to 1-973-629-1518.  For questions contact Maquet Customer Service at 1-888-627-8383 option 2 followed by option 2 Monday through Friday between 8 amd and 6 pm. EST.",
      "product_quantity": "305 units",
      "distribution_pattern": "Worldwide Distribution - US Nationwide",
      "openfda": {
        "k_number": [
          "K191402",
          "K896974",
          "K896971",
          "K896975",
          "K071521",
          "K003145",
          "K014016",
          "K883603",
          "K220635",
          "K945720",
          "K873813",
          "K841402",
          "K896972",
          "K130300",
          "K140012",
          "K873924",
          "K896973",
          "K896393",
          "K001520",
          "K212657",
          "K874927",
          "K031544",
          "K822874",
          "K052601",
          "K831677",
          "K102147",
          "K873699",
          "K893940",
          "K810647",
          "K122813"
        ],
        "registration_number": [
          "1723241",
          "3001588119",
          "1828100",
          "1516825",
          "3007899424",
          "1928237",
          "3006073153",
          "1649914",
          "1720929",
          "9611109"
        ],
        "fei_number": [
          "3001588119",
          "1828100",
          "1516825",
          "3007899424",
          "1928237",
          "1000517719",
          "3002808267",
          "3006073153",
          "3001665800",
          "1720929"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}