{
  "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": "532,395",
      "code_info": "All Lots.  Catalog prefixes HNR5.0    Catalog/product number; Global/order number  HNR5.0-35-100-P-10S-0 G09697  HNR5.0-35-100-P-10S-CFP G11264  HNR5.0-35-100-P-10S-PIG G09059  HNR5.0-35-100-P-8S-VCF G31403  HNR5.0-35-100-P-NS-0 G10313  HNR5.0-35-100-ST-10S-0 G09565  HNR5.0-35-100-ST-10S-PIG G09525  HNR5.0-35-110-P-10S-0 G11241  HNR5.0-35-110-P-10S-PIG G11265  HNR5.0-35-65-P-8S-VCF G12129  HNR5.0-35-70-P-10S-0 G09411  HNR5.0-35-70-P-10S-CFP G11262  HNR5.0-35-70-P-10S-PIG G08832  HNR5.0-35-70-P-10S-PIG-RICKETTS-081983 G11280  HNR5.0-35-70-P-4S-PED G11281  HNR5.0-35-70-P-NS-0                      G11959  HNR5.0-35-70-ST-10S-0 G09564  HNR5.0-35-70-ST-10S-PIG G09050  HNR5.0-35-80-P-8S-NEFF-CANADA-082098 G11860  HNR5.0-35-90-P-10S-0 G09412  HNR5.0-35-90-P-10S-CFP G11266  HNR5.0-35-90-P-10S-PIG G09408  HNR5.0-35-90-P-10S-PIG-RICKETTS-081983 G11282  HNR5.0-35-90-P-6S-PED G11729  HNR5.0-35-90-P-8S-VCF G12799  HNR5.0-35-90-ST-10S-0 G11641  HNR5.0-35-90-ST-10S-PIG G09197  HNR5.0-38-100-P-10S-0 G11267  HNR5.0-38-100-P-10S-CFP G11268  HNR5.0-38-100-P-10S-PIG G09285  HNR5.0-38-100-P-NS-0 G27874  HNR5.0-38-110-P-10S-0 G09461  HNR5.0-38-110-P-10S-PIG G11269  HNR5.0-38-70-P-10S-0 G11270  HNR5.0-38-70-P-10S-CFP G11271  HNR5.0-38-70-P-10S-PIG G11272  HNR5.0-38-70-P-NS-0                      G11289  HNR5.0-38-80-P-10S-OPC G27877  HNR5.0-38-90-P-10S-0 G11273  HNR5.0-38-90-P-10S-CFP G11274  HNR5.0-38-90-P-10S-PIG G11275",
      "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 Royal Flush Plus High-Flow 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-2611-2016",
      "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"
    }
  ]
}