{
  "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-2210-2016",
      "product_description": "Preamendments device-Sarns  Dual Cooler-Heater.      The Sarns Dual Cooler-Heater is a self-contained unit for supplying cold and warm water to heat exchangers during open heart surgery. It supplies water at a rate of up to 6.5 gallons per minute (25 liters per minute) at zero head, and will provide a maximum pressure output of 11 pounds per square inch (76,000  pascals). The Sarns TM Dual Cooler-Heater can be used with heat exchangers capable of accepting these flows and pressures.    Product Usage:  The Sarns Dual Cooler-Heater is indicated for use as a water supply system to a blood heat exchanger in open-heart surgery.",
      "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 Inter chlor 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 Dual Cooler-Heater ; Dual Cooler Heater 115V/60Hz (P/N 11160);  Dual Cooler Heater 220V/50Hz (P/N 4332);  Dual Cooler Heater 1 OOV/60Hz (P/N 14114);  Dual Cooler Heater 1 OOV/50Hz (PIN 13460)",
      "more_code_info": ""
    }
  ]
}