{
  "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": "2026-10-24",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "cfres_id": "171458",
      "product_res_number": "Z-1099-2019",
      "event_date_initiated": "2018-09-14",
      "event_date_created": "2019-04-06",
      "recall_status": "Terminated",
      "event_date_terminated": "2022-09-14",
      "res_event_number": "82365",
      "product_code": "DWC",
      "k_numbers": [
        "K052601"
      ],
      "product_description": "SORIN Heater-Cooler System 3T, REF 16-02-85\n\nIntended for use with a Stockert/Sorin S3/S5/C5 heart-lung machine and/or any other heart-lung machine featuring a separate temperature control for extracorporeal perfusion of durations of up to 6 hours.",
      "code_info": "Serial numbers 16S13187, 16S14887, 16S15335, 16S15336, 16S15337, and 16S11877.",
      "firm_fei_number": "1718850",
      "recalling_firm": "LivaNova USA Inc.",
      "address_1": "14401 W 65th Way",
      "city": "Arvada",
      "state": "CO",
      "postal_code": "80004-3503",
      "reason_for_recall": "For six units, the post-deep cleaning (DC) water sample tested positive for nontuberculous mycobacteria (NTM).",
      "root_cause_description": "Material/Component Contamination",
      "action": "The recalling firm, LivaLova, contacted the first customer by phone on 9/14/2018 followed by an \"IMPORT\" letter, the first of which was dated 9/18/2018. The letter described the product, problem and actions to be taken. The customers were instructed to do the following: keep these devices out of service until the investigation is complete. To return your device, please email 3T.US@livanova.com.\n\nIf taking Serial Numbers 16S15335 and 16S15337 out of service will negatively impact your clinical practice, we can arrange for delivery of loaner devices during this investigation and,as necessary, while they undergo repeat Deep Cleaning Process.\n\nIf you have any  questions, contact  V.P., Clinical, Quality, and Regulatory Services at  303-467-6306 or email:  joan.ceasar@livanova.com.",
      "product_quantity": "6 devices",
      "distribution_pattern": "US Distribution to states of: IN, MO, and OH.",
      "openfda": {
        "k_number": [
          "K140012",
          "K102147",
          "K810647",
          "K014016",
          "K873813",
          "K130300",
          "K220635",
          "K896975",
          "K191402",
          "K896972",
          "K896973",
          "K831677",
          "K001520",
          "K873699",
          "K896974",
          "K896393",
          "K841402",
          "K874927",
          "K031544",
          "K052601",
          "K883603",
          "K122813",
          "K212657",
          "K945720",
          "K896971",
          "K822874",
          "K893940",
          "K071521",
          "K003145",
          "K873924"
        ],
        "registration_number": [
          "9611109",
          "1649914",
          "1928237",
          "1828100",
          "3007899424",
          "1723241",
          "3001588119",
          "1516825",
          "1720929",
          "3006073153"
        ],
        "fei_number": [
          "3001665800",
          "3002808267",
          "1928237",
          "1828100",
          "1000517719",
          "3007899424",
          "3001588119",
          "1516825",
          "1720929",
          "3006073153"
        ],
        "device_name": "Controller, Temperature, Cardiopulmonary Bypass",
        "medical_specialty_description": "Cardiovascular",
        "regulation_number": "870.4250",
        "device_class": "2"
      }
    }
  ]
}