{
  "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": "2026-04-22",
    "results": {
      "skip": 0,
      "limit": 1,
      "total": 1
    }
  },
  "results": [
    {
      "country": "United States",
      "city": "Arvada",
      "address_1": "14401 W 65th Way",
      "reason_for_recall": "On August 1, 2014 Sorin Group USA, Inc. informed consignees via letter to review the disinfection and monitoring practices and to strictly adhere to the instructions in the Instructions for Use (\u001cIFU\u001d).",
      "address_2": "",
      "product_quantity": "1,618 units in the US; 129 units outside of US",
      "code_info": "All Serial Numbers",
      "center_classification_date": "20161201",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide and Puerto Rico) and Internationally to Canada, Colombia, Ecuador, El Salvador, Germany, Honduras, Mexico, Saudi Arabia, Trinidad, and Tobago.",
      "state": "CO",
      "product_description": "ST¿CKERT Heater\u0010Cooler System 3T; Item Number 16\u001002\u001081, Heater\u0010Cooler 3T, 240V/60Hz; Item Number 16\u001002\u001082, Heater\u0010Cooler 3T, 208V/60Hz; Item Number 16\u001002\u001085, Heater\u0010Cooler 3T, 120V/ 60Hz  The Heater Cooler 3T is used with a St¿ckert S3 heart lung machine and / or any other heart lung machine featuring a separate temperature control for extracorporeal perfusion of durations up to 6 hours",
      "report_date": "20161207",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Sorin Group USA, Inc.",
      "recall_number": "Z-0682-2017",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "75573",
      "termination_date": "20170420",
      "more_code_info": "",
      "recall_initiation_date": "20140801",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}