{
  "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": "During a retrospective review of complaint events, TCVS identified on 06/15/12 that three (3)  Sarns\" System 8000 bases were manufactured and distributed from 11/13/06-11/29/06 with an  incorrect incorrect amperage rating identified on the name plate label. The mislabeling was  identified in January 2007 a set up process of the automark label printer. All units were corrected  in the field in Marc",
      "address_2": "",
      "product_quantity": "3",
      "code_info": "catalog number: 16401 and serial number: 2001, 2002, and 2003.",
      "center_classification_date": "20120816",
      "distribution_pattern": "US Nationwide Distribution - including the state of New York",
      "state": "MI",
      "product_description": "System 8000 Base    Product Usage:  The Sarns\u001d Modular Perfusion System 8000 is indicated for use for up to 6 hours on the extracorporeal circulation of blood for arterial perfusion, regional perfusion, and cardiopulmonary bypass procedures, when used by a qualified medical professional who is experienced in the operation of this or similar equipment.",
      "report_date": "20120822",
      "classification": "Class III",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-2218-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62732",
      "termination_date": "20121107",
      "more_code_info": "",
      "recall_initiation_date": "20120620",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}