{
  "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,
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  },
  "results": [
    {
      "cfres_id": "158835",
      "product_res_number": "Z-0629-2018",
      "event_date_initiated": "2017-11-27",
      "event_date_posted": "2018-02-13",
      "recall_status": "Terminated",
      "event_date_terminated": "2018-07-02",
      "res_event_number": "78173",
      "product_code": "DWC",
      "k_numbers": [
        "K122813"
      ],
      "product_description": "Hemotherm Dual Reservoir Cooler/Heater System Models 400CE and 400MR\nProduct Usage:\nA dual reservoir, water re-circulating device that supplies temperature controlled water to a heat exchanger. The device, in conjunction with a heat exchanger, is used to warm or cool the blood that enters and exits a blood heat exchanger for adult, pediatric or infant patients.",
      "code_info": "none",
      "firm_fei_number": "1516825",
      "recalling_firm": "Cincinnati Sub-Zero Products LLC",
      "address_1": "12011 Mosteller Rd",
      "city": "Cincinnati",
      "state": "OH",
      "postal_code": "45241-1528",
      "additional_info_contact": "Kathy DeSmidt\n513-772-8810",
      "reason_for_recall": "Due to FDA's safety communication relating to nontuberculous mycobacteria (NTM) infections related to heater/cooler devices, an updated Instructions For Use includes a more robust cleaning & disinfection procedure.",
      "root_cause_description": "Device Design",
      "action": "Between November 27, 2017 - December 8, 2017, Cincinnati Sub-Zero Products LLC, distributed Urgent Medical Device Correction notices to their customers via Email and USPS.  This Medical Device Correction has been initiated to provide a labeling update to the cleaning & disinfection procedures.  The update addresses the disinfection process, cleaning of reusable accessories, as well as clarifying the water type that should be used with the Hemotherm.  Customers are encouraged to do the following: 1) Discard your current Hemotherm Operation & Technical Manual and/or Operation Manual.  2) Replace your current Hemotherm Operation & Technical Manual and/or Operation Manual with the enclosed updated Manual(s).  For your convenience, all updates have been highlighted in the manuals.  \n\"\tFor Hemotherm 400CE users, utilize the P/N 56418-R Operation & Technical Manual and P/N 56075-G Operation Manuals.  \n\"\tFor Hemotherm 400MR users, utilize the P/N 56234-S Operation Manual.\nAll customers are encouraged to complete and return the enclosed response form by fax or email to FA2016-009@genthermcsz.com; Fax: 513-772-9119.\nCustomers with questions or concerns, please contact the Field Action Coordinator: Kathy DeSmidt, E-mail: FA2016-009@genthermcsz.com, \nPhone: 513-772-8810 or 800-989-7373.",
      "product_quantity": "1355 units",
      "distribution_pattern": "US Nationwide Distribution",
      "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"
      }
    }
  ]
}