{
  "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": "2026-04-15",
    "results": {
      "skip": 0,
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  "results": [
    {
      "country": "United States",
      "city": "Wayne",
      "address_1": "45 Barbour Pond Dr",
      "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.",
      "address_2": "",
      "product_quantity": "305 units",
      "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.",
      "center_classification_date": "20161102",
      "distribution_pattern": "Worldwide Distribution - US Nationwide",
      "state": "NJ",
      "product_description": "Heater Cooler Unit    Usage:  The 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.",
      "report_date": "20161109",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Maquet Cardiovascular Us Sales, Llc",
      "recall_number": "Z-0348-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75271",
      "termination_date": "20190819",
      "more_code_info": "",
      "recall_initiation_date": "20160927",
      "postal_code": "07470-2094",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}