{
  "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": [
    {
      "status": "Terminated",
      "city": "Limerick, Peroc",
      "state": "N/A",
      "country": "Ireland",
      "classification": "Class II",
      "openfda": {},
      "product_type": "Devices",
      "event_id": "61451",
      "recalling_firm": "Cook Ireland Ltd.",
      "address_1": "O'holloran Road,",
      "address_2": "National Technological Park",
      "postal_code": "N/A",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "initial_firm_notification": "Other",
      "distribution_pattern": "Worldwide distribution: USA (nationwide) and country of: Japan.",
      "recall_number": "Z-2309-2012",
      "product_description": "Zilver 518 Vascular Self Expanding Stent    The Zilver Vascular Stent is intended for use as an adjunct to percutaneous transluminal angioplasty (PTA) in the treatment of symptomatic disease of iliac arteries up to 100 mm in length with a reference vessel diameter of 5 to 9 mm. Patients should be suitable candidates for PTA and / or stent treatment.",
      "product_quantity": "15 units of ZIV5-18-125-8-80 LOT# CF694429",
      "reason_for_recall": "Cook Ireland received a product complaint from Japan on December 22nd, 2011.  The complainant reported that a 5 French Zilver Vascular Stent (part number ZIV5-18-125-8-80 from Lot# CF694429) was inserted into a sheath over a wire guide where it became lodged in the sheath hub.  After further examination, the user determined that the product was a 6 French Zilver Vascular Stent (part number ZIV6-35",
      "recall_initiation_date": "20120105",
      "center_classification_date": "20120831",
      "termination_date": "20130204",
      "report_date": "20120912",
      "code_info": "Part order number: ZIV5-18-125-8-80; Lot Number: CF694429; Expiration Date: 09-2014"
    }
  ]
}