{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Ann Arbor",
      "address_1": "6200 Jackson Road",
      "reason_for_recall": "Based on a retrospective review of quality data, AC Control boards used in the manufacture of the  HX2 Temperature Management System were identified as being manufactured using the incorrect  flux material. Use of the incorrect flux may contribute to premature board failure. A search of  TCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred  during set up",
      "address_2": "",
      "product_quantity": "19 units",
      "code_info": "Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.",
      "center_classification_date": "20121113",
      "distribution_pattern": "Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI",
      "state": "MI",
      "product_description": "HX2 Temp Manage SYS 120V    The Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.",
      "report_date": "20121121",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-0278-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "63344",
      "termination_date": "20130711",
      "more_code_info": "",
      "recall_initiation_date": "20121016",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}