{
  "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 (Terumo CVS) has received multiple reports since 2007 of various malfunctions of the arterial and cardioplegia monitors for the Sarns Modular  Perfusion System 8000. The malfunctions can be broadly categorized as follows monitor power malfunctions, inability to measure pressure and inaccurate and/or false pressure  alarms.  If the malfunction of the arterial or cardio",
      "address_2": "",
      "product_quantity": "1097",
      "code_info": "catalog number: 16401 serial numbers: 1001-1243, 1247-1648, 1650-1821, and 1824-3003.",
      "center_classification_date": "20121113",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) including states of:  AK, AL, AR, AZ, CA, CO, CT, DC, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NH, NJ, NM, NY, OH, OK, OR, PA, RI, SC, TN, TX, VA, WA, WI, WV, and WY; and countries of:  ARGENTINA, AUSTRALIA, BANGLADESH, BRAZIL, CALI COLOMBIA, CALLO PERU, GERMANY, GUAYQUIL ECUADOR, HONG KONG, INDIA, INDONESIA, JAPAN, LEBANON, MADRID SPAIN, MEXICO, NEW ZEALAND, SANTIAGO, SANTIAGO CHILE, SINGAPORE, SOUTH AFRICA, SOUTH KOREA, SRI LANKA, TAIWAN, THAILAND, and UNITED ARAB EMIRATES (UAE).",
      "state": "MI",
      "product_description": "Perfusion System 8000, base 5 pump, 115V safety monitor included    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": "20121121",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "recall_number": "Z-0281-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "62733",
      "termination_date": "20130711",
      "more_code_info": "",
      "recall_initiation_date": "20120925",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}