{
  "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": "Santa Clara",
      "address_1": "5452 Betsy Ross Dr",
      "reason_for_recall": "AccessClosure, Inc. (ACI) is voluntarily recalling the PAXWIRE Occlusion Balloon System device   because it was made aware from customers that the device may be removed in the absence of vascular sheath across the arteriotomy.  This is a deviation from the firm's standard catheterization technique.",
      "address_2": "",
      "product_quantity": "6 in USA",
      "code_info": "Product Model ACX101,  Manufacturer UDI *+ M465ACX10106*    Lot No: F1614503",
      "center_classification_date": "20161021",
      "distribution_pattern": "US distribution to FL and NJ",
      "state": "CA",
      "product_description": "The PAXWIRE Occlusion Balloon System consists of an occlusion catheter, inflation handle and syringes. It is designed for use in the iliofemoral artery to provide temporary occlusion as well as a path for dilator and/or sheath introduction, removal or repositioning during catheterization procedures.",
      "report_date": "20161102",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "AccessClosure, Inc., A Cardinal Health Company",
      "recall_number": "Z-0297-2017",
      "initial_firm_notification": "",
      "product_type": "Devices",
      "event_id": "75376",
      "termination_date": "20161114",
      "more_code_info": "",
      "recall_initiation_date": "20161006",
      "postal_code": "95054-1101",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}