{
  "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": "2026-04-15",
    "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": "74389",
      "recalling_firm": "Terumo Cardiovascular Systems Corporation",
      "address_1": "6200 Jackson Rd",
      "address_2": "N/A",
      "postal_code": "48103",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "Domestic: AK, AL, AR, AZ, CA , CO, CT, DC , DE , FL, GA, HI, IA, ID, IL, IN, KS, KY,LA , MA, MD, ME, MI , MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV , NY, OH, OK, OR, PA, PR, RI, SC, SD, TN, TX, UT,    VA, WA, WI, WV, WY     Foreign: Argentina, Australia, Belgium,Brazil, Canada, Chile, China, Colombia, Costa Rica, Dominican Republic,              Ecuador, El Salvador, England, Finland, France, Germany  Greece, Hong Kong, India, Indonesia, Iran, Ireland, Israel,   Italy, Jamaica, Japan, Jordan, Korea, Lebanon, Malaysia  Malta, Mexico, Netherlands, New Zealand, Norway, Philippines, Portugal, Russia, Saudi Arabia, Singapore, South Korea,            Spain, Sweden, Switzerland, Taiwan,                Thailand, Turkey, United Arab Emirates , Uruguay ,                     Venezuela, Vietnam",
      "recall_number": "Z-2209-2016",
      "product_description": "Sarns TCM II;     The Sarns Temperature Control and Monitor unit (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.    Product Usage:  The Sarns TCM II is indicated for controlling and monitoring patient temperature.",
      "product_quantity": "6412 units",
      "reason_for_recall": "Terumo Cardiovascular Systems (Terumo CVS) is conducting a voluntary recall of its heater-cooler devices due to the distributor  no longer selling the Interchlor sanitizer (Product Code 205) referenced in its heater-cooler cleaning instructions.",
      "recall_initiation_date": "20160608",
      "center_classification_date": "20160718",
      "termination_date": "20170804",
      "report_date": "20160727",
      "code_info": "The Sarns Temperature Control and Monitor unit (TCM), TCM II TUV, 115V (P/N 4415),  TCM II TUV, 220V (P/N 4416),  TCM II, with Cardioplegia, 11 OV/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)",
      "more_code_info": ""
    }
  ]
}