{
  "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
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  },
  "results": [
    {
      "country": "United States",
      "city": "Arvada",
      "address_1": "14401 W 65th Way",
      "reason_for_recall": "The tip of the cannula should be bent at either a 45 or 90 degree angle. Samples have been returned where the angle of the tip is less than the requirement.",
      "address_2": "",
      "product_quantity": "1205 units worldwide",
      "code_info": "Lot Numbers: 1425900137, 1433900079, 1433900080, 1435300088.",
      "center_classification_date": "20160908",
      "distribution_pattern": "Worldwide Distribution - US including IL, MO, TX. Internationally to Canada and Italy.",
      "state": "CO",
      "product_description": "Coronary Artery Perfusion Cannula with Balloon (part number CP-2200X). The Coronary Artery Perfusion Cannula with Balloon The Cannula consists of a single lumen vinyl tube provided for with a vinyl female luer connector bonded proximally and a vinyl cuff bonded distally. The cuff is pre-molded to its inflated configuration and is purposely positioned directly over a hole generated in the extruded tube for purposes of receiving the infused cardioplegia solution. These devices come in direct contact with the central circulatory system but they are not intended to control, diagnose, monitor or correct a defect.",
      "report_date": "20160914",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Sorin Group USA, Inc.",
      "recall_number": "Z-2757-2016",
      "initial_firm_notification": "Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit",
      "product_type": "Devices",
      "event_id": "74934",
      "termination_date": "20170327",
      "more_code_info": "",
      "recall_initiation_date": "20160812",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}