{
  "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": "70820",
      "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.",
      "recall_number": "Z-1371-2015",
      "product_description": "Edwards Lifesciences Fem-Flex II Femoral Arterial Cannula 8, 10, 12 French,Sterile EO, Rx Only, Manufacturer Edwards Lifesciences LLC,  Irvine, CA.-Model Numbers: FEMII008A, FEMII008AT, FEMII008V, FEMII010A, FEMII010AT, FEMII010V, FEMII012A, FEMII012AT, and FEMII012V.    Edwards Femoral Access Cannulae are intended to provide a means of draining the blood flow (venous), or perfusing blood into the body (arterial) of a patient during cardiopulmonary bypass procedures.",
      "product_quantity": "5125 units",
      "reason_for_recall": "Edwards Lifesciences is recalling Fem-Flex II Pediatric Femoral Arterial Cannula sizes 8, 10, 12 French because of the potential of tissue damage caused by a protruding wire located at the tip of the cannula.",
      "recall_initiation_date": "20150323",
      "center_classification_date": "20150402",
      "termination_date": "20170417",
      "report_date": "20150408",
      "code_info": "Model/Lot Numbers:  FEMII008A/59751073, 59775775, 59775776, 59775777 & 59852930;  FEMII008AT/59807985, 59867050, & 59873263;   FEMII008V/59873250 & 59873251;  FEMII010A/59740468, 59773806, 59792415,  59792416 & 59852934;   FEMII010AT/ 59747819, 59807986,59852935, 59890916 & 59896910;  FEMII010V/59751074, 59849119 & 59890924;  FEMII012A/ 59801792,59867064, 59884766 & 59884778   FEMII012AT/59852940 & 59867051; and   FEMII012V/59723307, 59796683, 59849124 & 59873252"
    }
  ]
}