{
  "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": "Saint Paul",
      "address_1": "1 Saint Jude Medical Dr",
      "reason_for_recall": "St. Jude Medical is conducting a voluntary recall of SMJ Batch # 4641580 of the Fast-Cath Trio\" Hemostasis Introducer, Catalog number 406308. The inner diameter of the 10F dilator is too small, such that the guidewire cannot advance through the device which may result in a procedural delay while another dilator of the desired size is obtained.",
      "address_2": "",
      "product_quantity": "220",
      "code_info": "Batch 4641580",
      "center_classification_date": "20141021",
      "distribution_pattern": "Nationwide Distribution including FL, IN, ME, MA, NY, NY, OH, RI,TX, and WV.",
      "state": "MN",
      "product_description": "St Jude Medical, 10F Fast-Cath Trio\" Hemostasis Introducer, REF #  406308, Sterile EO.    The Fast-Cath Trio\" Hemostasis Introducer consists of the following components: Port hemostasis adapter (3), Sheath (10F Cath-Lock\"), dilator (10F) and 0.038\u001d guidewire.  See product labeling for diagram of contents.",
      "report_date": "20141029",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "St Jude Medical",
      "recall_number": "Z-0108-2015",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "69499",
      "termination_date": "20150325",
      "more_code_info": "",
      "recall_initiation_date": "20141014",
      "postal_code": "55117-1789",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}