{
  "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-2207-2016",
      "product_description": "HX2\" Temperature Management Systems;     The Terumo¿ HX2\" Temperature Management System provides temperature control of two independent water circuits that directly controls the temperature of patient blood and cardioplegia solution during cardiovascular surgery.  The system consists of a water tank, circulating pumps, heater manifolds, mercury free temperature sensors, water detectors, mixing valves and a tank divider which is provided to partition the tank into two separate channels (Left and Right).The system has the capacity to circulate water at a rate of up to  6.5 gal.min (25 L/min) with no load connected. The system is capable of heating and cooling for a single channel or for both channels.    Product Usage:  HX2\u001d Temperature Management Systems is indicated for use to supply temperature regulated water to heat exchangers during 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 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": "HX2\" Temperature Management Systems, P/N 809810, Catalog Number 809810",
      "more_code_info": ""
    }
  ]
}