{
  "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": [
    {
      "status": "Terminated",
      "city": "Draper",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "64782",
      "recalling_firm": "Edwards Lifesciences, LLC",
      "address_1": "12050 Lone Peak Pkwy",
      "address_2": "N/A",
      "postal_code": "84020-9414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Letter",
      "distribution_pattern": "USA Nationwide Distribution including the states of: FL, MA, MI, NY, PA, TX.",
      "recall_number": "Z-1111-2013",
      "product_description": "Edwards Lifesciences Duraflo coated Femoral Cannula.        Product Usage:  The cannulae are intended for use in situations which require rapid femoral venous and arterial access for short-term (< 6 hours) cardiopulmonary bypass. Vessel access (venous or arterial) is left to the discretion of the physician. Extracorporeal circuit components with a Duraflo coating are intended for use in cardiopulmonary surgery when a heparin-coated blood path is desired.  The femoral arterial cannulae are wire-reinforced, thin-wall cannulae.",
      "product_quantity": "379 units",
      "reason_for_recall": "Two unsealed pouches were found at an Edwards' distribution location in Japan.  Incorrectly sealed pouches may result in a sterility barrier breach.",
      "recall_initiation_date": "20130314",
      "center_classification_date": "20130414",
      "termination_date": "20160308",
      "report_date": "20130424",
      "code_info": "Model DIIFEMII018A, Lot 59337174"
    }
  ]
}