{
  "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": [
    {
      "country": "United States",
      "city": "Arvada",
      "address_1": "14401 W 65th Way",
      "reason_for_recall": "Sorin Group USA is recalling Aortic Arch Cannulae (part numbers NA-55X7 and NA-55X8) because the distal end may be less than specified.  The defective cannula are showing an angle that is about 15-20 degrees instead of approximately 45 degrees.",
      "address_2": "",
      "product_quantity": "5740",
      "code_info": "Lots: 1505600017 ; 1505600018 ; 1506500005 ; 1509200078 ; 1513100112 ; 1513900027 ; 1513900028 ; 1514700045 ; 1516600192 ; 1516800126 ; 1517800004 ; 1519500037 ; 1520100049 ; 1520100050 ; 1520900031 ; 1520900033 ; 1521600126 ; 1523000093 ; 1523600120 ; 1525100023 ; 1525800026 ; 1526500032 ; 1526500033 ; 1526500034 ; 1526500072 ; 1527200050 ; 1527200051 ; 1527200052 ; 1527800163 ; 1529300026 ; 1529300027 ; 1529300028 ; 1533500033 ; 1534200034 ; 1601900027 ; 1601900028 ;",
      "center_classification_date": "20160708",
      "distribution_pattern": "Worldwide Distribution: US (nationwide) to states of: LA, Ml, MO, OH, TN, and TX; and countries of: Italy and Canada.",
      "state": "CO",
      "product_description": "AORTIC ARCH CANNULA, Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (part numbers NA-55X7 and NA-55X8)    Aortic Arch Cannulae are designed to be used in the extracorporeal circuit during cardiopulmonary bypass surgery. The cannula consists of varying lengths of non-wire reinforced (flexible) polyvinyl chloride tubing that terminates in an angled tip. 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": "20160720",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Sorin Group USA, Inc.",
      "recall_number": "Z-2147-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74490",
      "termination_date": "20170327",
      "more_code_info": "",
      "recall_initiation_date": "20160622",
      "postal_code": "80004-3503",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}