{
  "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": "Draper",
      "address_1": "12050 Lone Peak Pkwy",
      "reason_for_recall": "Edwards Lifesciences is recalling certain Proplege Coronary Sinus Catheter, model PR9 due to confirmed reports of blood leakage through the hemostasis valve in the introducer that is kitted with the catheter.",
      "address_2": "",
      "product_quantity": "807",
      "code_info": "Model PR9, lot numbers: 59385159, 59385164, 59385204, 59398000, 59398006, 59398008, 59400402, 59423199, 59423200, 59385159, 59385164, 59385204, 59398000, 59398006.",
      "center_classification_date": "20130514",
      "distribution_pattern": "Worldwide Distribution - USA Nationwide including the states of: MD, NY, PA, CA, FL, AZ, AL, TX, VA, OH, MO, NC, GA, TN, CO, OR, SC, ME, IL, HI, NJ, WA, WI, CT, KY, LA and Canada.",
      "state": "UT",
      "product_description": "Proplege Coronary Sinus Catheter model PR9, 11 French Introducer, kitted with PR9.    Product Usage:  The catheter introducer sheath kit provides access to the central venous circulation to facilitate catheter and guidewire insertion. The Proplege coronary sinus catheter provides retrograde cardioplegia during cardiopulmonary by-pass surgery.",
      "report_date": "20130522",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Edwards Lifesciences, LLC",
      "recall_number": "Z-1322-2013",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "64221",
      "termination_date": "20170216",
      "more_code_info": "",
      "recall_initiation_date": "20130125",
      "postal_code": "84020-9414",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}