{
  "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": "15 units",
      "code_info": "Catalog number: 817168 and serial numbers: 824POOO023,  831 P001130, 831 P001133, 831 P001136, 831 P001140, 831 POO1141 , 831 P001144, 831 P001145, 831 P001146, 831 P001149, 831 P001151,  831 P001159, 831P001161, 831P001164, and 836POOOO05.",
      "center_classification_date": "20121113",
      "distribution_pattern": "Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI",
      "state": "MI",
      "product_description": "Tested AC Control BD, 120V, X2    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-0279-2013",
      "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"
    }
  ]
}