{
  "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": "2026-05-06",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "status": "Terminated",
      "city": "Ann Arbor",
      "state": "MI",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "62321",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Road",
      "address_2": "N/A",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Worldwide distribution: International only-country of: Terumo Dubai, UAE",
      "recall_number": "Z-2348-2012",
      "product_description": "Safety monitor included with System 8000 Base    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. The safety monitor is indicated to warn when the blood level in the reservoir reaches the operator-set limit, and to stop the arterial and cardioplegia pumps.",
      "product_quantity": "8",
      "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) received complaints from our Affiliate, Terumo  Dubai that the safety monitors were tripping off. Terumo CVS' investigation determined that 8  monitors were manufactured with an underrated circuit breaker due to an error where an associate  pulled an underrated circuit breaker from an incorrect inventory location. Since this time, inventory  locations hav",
      "recall_initiation_date": "20090812",
      "center_classification_date": "20120911",
      "termination_date": "20130129",
      "report_date": "20120919",
      "code_info": "catalog number 16404 and serial numbers: 4357, 4381, 4386, 4387, 4389, 4391, and 4392."
    }
  ]
}