{
  "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": "Bloomington",
      "address_1": "750 N Daniels Way",
      "reason_for_recall": "Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation.  degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.",
      "address_2": "",
      "product_quantity": "332,255",
      "code_info": "All Lots.  Catalog prefixes NR5.0    Catalog/product number; Global/order number  Centimeter Sizing:  NR5.0-35-70-P-10S-VCF-CSC-20 G31220  NR5.0-35-70-P-10S-PIG-CSC-20 G31215  NR5.0-35-70-P-10S-0-CSC-20 G31213  NR5.0-35-100-P-10S-VCF-CSC-20 G31221  NR5.0-35-100-P-10S-PIG-CSC-20 G31216  NR5.0-35-100-P-10S-0-CSC-20 G31214  White Vessel Sizing:  NR5.0-35-70-P-10S-PIG-WSC G31224  NR5.0-35-70-P-10S-CFP-WSC G31227  NR5.0-35-70-P-10S-0-WSC G31228  NR5.0-35-65-P-6S-VCF-WSC G31229  NR5.0-35-100-P-10S-PIG-WSC G31226  Vessel Sizing:  NR5.0-35-90-P-10S-VCF-CAVA G31233  NR5.0-35-90-P-10S-PIG-CAVA G31231  NR5.0-35-70-P-10S-VCF-CAVA G31232  NR5.0-35-70-P-10S-PIG-CAVA G31230",
      "center_classification_date": "20160822",
      "distribution_pattern": "Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, \"Palestinian Territory, Occupied\", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.",
      "state": "IN",
      "product_description": "Beacon Tip Centimeter Sizing Catheter  Beacon Tip White Vessel Sizing Catheter  Beacon Tip Vessel Sizing Catheter    Catheter, Intravascular, Diagnostic  The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.",
      "report_date": "20160831",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cook Inc.",
      "recall_number": "Z-2612-2016",
      "initial_firm_notification": "Letter",
      "product_type": "Devices",
      "event_id": "74010",
      "termination_date": "20170804",
      "more_code_info": "",
      "recall_initiation_date": "20160415",
      "postal_code": "47404-9120",
      "voluntary_mandated": "Voluntary: Firm initiated",
      "status": "Terminated"
    }
  ]
}