{
  "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": "Terumo Cardiovascular Systems has received several reports of malfunctions of the Air Bubble Detection System used with its heart-lung machines over the last three years. The malfunctions were expressed in various failure modes (over sensitivity, false alarms and were found to have various root causes. The malfunctions occurred in systems that were excluded from prior corrective actions or in syst",
      "address_2": "",
      "product_quantity": "274 units",
      "code_info": "Catalog Number 16400 and serial number 1001-1333",
      "center_classification_date": "20120719",
      "distribution_pattern": "Worldwide Distribution-USA (nationwide) and the countries of  ARGENTINA, BANGLADESH, BELGIUM, Bolivia, BRAZIL, BRISBANE, CANADA, CHILE, China, COLOMBIA, COLOMBIA, Costa Rica, DENMARK, Dominican Republic, Ecuador, Egypt, FRANCE, GERMANY, Guatemala, HOLLAND, Honduras, Hong Kong, India, INDIA, Indonesia, Israel, ITALY, Jordan, KOREA, Kuwait, Lebanon, LEICESTERSHIRE, Malaysia, Mexico, NETHERLANDS, New Zealand, Nicaragua, NORWAY, Pakistan, Panama, PERU, Philippines, Russia, Saudi Arabia, SINGAPORE , SOUTH AFRICA, South Korea, SPAIN, Sri Lanka, SWEDEN, SWITZERLAND, Taiwan, THAILAND, Turkey, UNITED ARAB EMIRATES (UAE), Uruguay, Venezuela, Vietnam, WEST GERMANY and Yemen.",
      "state": "MI",
      "product_description": "Sarns Modular Perfusion System 8000 base, 4 pump 115V.    The Sarns 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": "20120725",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-2044-2012",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "61479",
      "termination_date": "20130412",
      "more_code_info": "",
      "recall_initiation_date": "20120618",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}