{
  "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": "2026-04-08",
    "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": "87834",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Rd",
      "address_2": "",
      "postal_code": "48103-9586",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: Foreign: Australia, Belgium, Canada, Chile, China, Colombia, Dominican Republic, England, France, Germany, Greece, Hong Kong, India, Indonesia, Iran, Israel, Italy, Japan, Korea, Malaysia, Mexico, Netherlands, New Zealand, Norway, Philippines, Russia, Saudi Arabia, Singapore, South Korea, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, UNITED ARAB EMIRATES (UAE), Vietnam",
      "recall_number": "Z-1791-2021",
      "product_description": "The Sarns TCM II (system) is a source of temperature-controlled water for blood heat exchangers used in an extracorporeal circuit and for blankets to externally heat or cool the patient. It also freezes water for an ice supply, monitors temperatures in the patient and extracorporeal circuit, and allows gradient rewarming relative to a venous blood temperature.   The Sarns\" TCM II also features a Cardioplegia System which will supply cooling water for cardioplegia.    Device Name / Model Number:  TCM II, with Cardioplegia, 110V/60Hz (P/N 164925)  TCM II, without Cardioplegia, 110V/60Hz (P/N 164930)  TCM II, with Cardioplegia, 220V/50Hz (P/N 164935)  TCM II, without Cardioplegia, 220V/50Hz (P/N 164940)  TCM (P/N 15747)    Catalog Number: 4415, 164925, 164930, 164935, 15747",
      "product_quantity": "995 devices",
      "reason_for_recall": "Terumo CVS has been unable to validate a cleaning protocol to satisfy current regulatory concerns and expectations. As a result, an updated cleaning protocol will not be developed by Terumo CVS and it has been determined that the best course of action is for users to discontinue use of and dispose of HX2, TCM I and TCM II devices.",
      "recall_initiation_date": "20210416",
      "center_classification_date": "20210604",
      "termination_date": "20231129",
      "report_date": "20210609",
      "code_info": "All lot numbers distributed from 05/02/1985 thru 06/10/2015",
      "more_code_info": ""
    }
  ]
}