{
  "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": "2026-08-13",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "113534",
      "product_res_number": "Z-0278-2013",
      "event_date_initiated": "2012-10-16",
      "event_date_posted": "2012-11-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2013-07-11",
      "res_event_number": "63344",
      "product_code": "DWC",
      "k_numbers": [
        "K071521"
      ],
      "product_description": "HX2 Temp Manage SYS 120V\n\nThe Terumo HX2 Temperature Management System is a selfcontained, dual channel system for supplying temperature controlled water to heat exchangers used in an extracorporeal circuit.",
      "code_info": "Catalog number: 809810 and serial numbers: 1041, 1083, 1084, and 1101-1116.",
      "firm_fei_number": "1828100",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Road",
      "city": "Ann Arbor",
      "state": "MI",
      "postal_code": "48103-9586",
      "additional_info_contact": "734-741-6173",
      "reason_for_recall": "Based on a retrospective review of quality data, AC Control boards used in the manufacture of the\nHX2 Temperature Management System were identified as being manufactured using the incorrect\nflux material. Use of the incorrect flux may contribute to premature board failure. A search of\nTCVS complaints revealed 3 complaints received related to the HX2 failure. Each failure occurred\nduring set up",
      "root_cause_description": "Nonconforming Material/Component",
      "action": "TERUMO sent an Urgent Medical Device Recall letter dated October 15, 2012, to all affected customers.  The letter identified the product, the problem, and the action to be taken by the customer.  Terumo has determined that a field correction is required to notify affected customers that the boards may fail, instruct the users that in a case of failure to swich to the second channel on the device or use a back-up unit, and that TCVS will replace the affected boards.  Customers with questions were instructed to call 1-800-621-2818.  For questions regarding this recall call 734-741-6173.",
      "product_quantity": "19 units",
      "distribution_pattern": "Nationwide Distribution including CA, HI, KS, LA, MI, MO, OR, PA, UT, and WI",
      "openfda": {
        "k_number": [
          "K220635",
          "K031544",
          "K122813",
          "K945720",
          "K003145",
          "K874927",
          "K896974",
          "K841402",
          "K001520",
          "K212657",
          "K191402",
          "K896975",
          "K130300",
          "K052601",
          "K893940",
          "K140012",
          "K873699",
          "K014016",
          "K896972",
          "K873924",
          "K883603",
          "K896973",
          "K822874",
          "K102147",
          "K831677",
          "K071521",
          "K896971",
          "K896393",
          "K810647",
          "K873813"
        ],
        "registration_number": [
          "3007899424",
          "9611109",
          "1828100",
          "3001588119",
          "1516825",
          "1928237",
          "1649914",
          "3006073153",
          "1720929",
          "1723241"
        ],
        "fei_number": [
          "3007899424",
          "3001665800",
          "1828100",
          "3001588119",
          "1516825",
          "1928237",
          "3006073153",
          "1720929",
          "1000517719",
          "3002808267"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}