{
  "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": "Draper",
      "state": "UT",
      "country": "United States",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "71269",
      "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": "Nationwide Distribution -- US, including the states of Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Idaho, Illinois, Kentucky, Louisiana, Massachusetts, Maine, Michigan, Missouri, Mississippi, North Carolina, Nebraska, New Jersey, New York, Ohio, Oklahoma, Oregon, Pennsylvania, South Carolina, South Dakota, Tennessee, Texas, Utah, Virginia, Washington, Wisconsin, and West Virginia.",
      "recall_number": "Z-1758-2015",
      "product_description": "Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4\" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch    For use in patients undergoing cardiopulmonary bypass.",
      "product_quantity": "3,360 units.",
      "reason_for_recall": "Potential device damage on the strain relief near the hub area, which may result in blood leakage.",
      "recall_initiation_date": "20150505",
      "center_classification_date": "20150610",
      "termination_date": "20171212",
      "report_date": "20150617",
      "code_info": "All lots within expiration.   59443555  59613944  59655681  59718185  59751955  59829691  59913251  59973802  59473497  59613945  59655682  59718186  59757492  59829692  59914824  59973803  59478792  59630641  59655683  59718187  59767963  59842135  59914825  59979641  59478793  59644480  59677638  59721969  59790316  59853386  59914826  59979642  59490124  59644481  59695842  59721970  59790317  59853387  59936991  59999093  59523568  59644482  59695843  59721971  59801106  59856575  59936992  60016315  59559537  59649627  59695844  59734231  59801107  59872381  59962951  60031031  59585111  59649628  59718182  59734232  59806707  59895500  59962952  59597667  59655679  59718183  59751953  59812135  59901268  59962953  59598246  59655680  59718184  59751954  59824839  59904370  59967598"
    }
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}