{
  "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": "298,340",
      "code_info": "All Lots.  Catalog prefixes SCBR5.0, SCBR5.5, and SCBR6.5    Catalog/product number; Global/order number  SCBR5.0-38-100-P-NS-0 G12005  SCBR5.0-38-100-P-NS-C2 G12008  SCBR5.0-38-100-P-NS-DAV G11996  SCBR5.0-38-100-P-NS-H1 G11991  SCBR5.0-38-100-P-NS-HN4 G23693  SCBR5.0-38-100-P-NS-JB1 G11997  SCBR5.0-38-100-P-NS-JB2 G11998  SCBR5.0-38-100-P-NS-KMP G28535  SCBR5.0-38-100-P-NS-MAN G11999  SCBR5.0-38-100-P-NS-MPA G12002  SCBR5.0-38-100-P-NS-NTR G23695  SCBR5.0-38-100-P-NS-RVC G43120  SCBR5.0-38-100-P-NS-SIM1 G12000  SCBR5.0-38-100-P-NS-SIM2 G11992  SCBR5.0-38-100-P-NS-SIM3 G12001  SCBR5.0-38-100-P-NS-TEGT G23694  SCBR5.0-38-100-P-NS-VERT G12007  SCBR5.0-38-100-P-NS-VTK G13163  SCBR5.0-38-125-P-NS-0 G32366  SCBR5.0-38-125-P-NS-DAV G13413  SCBR5.0-38-125-P-NS-H1 G23696  SCBR5.0-38-125-P-NS-JB1 G13530  SCBR5.0-38-125-P-NS-SIM1 G32369  SCBR5.0-38-125-P-NS-SIM2 G13200  SCBR5.0-38-125-P-NS-TEGT G32367  SCBR5.0-38-125-P-NS-VERT G12168  SCBR5.0-38-125-P-NS-VTK G12082  SCBR5.0-38-40-P-NS-KMP G11993  SCBR5.0-38-65-P-NS-0 G12009  SCBR5.0-38-65-P-NS-C1 G12003  SCBR5.0-38-65-P-NS-C2 G11994  SCBR5.0-38-65-P-NS-C3 G12004  SCBR5.0-38-65-P-NS-DAV G23688  SCBR5.0-38-65-P-NS-H1 G13319  SCBR5.0-38-65-P-NS-KMP G12156  SCBR5.0-38-65-P-NS-LEV1 G12798  SCBR5.0-38-65-P-NS-MPA G23689  SCBR5.0-38-65-P-NS-RC2 G13272  SCBR5.0-38-65-P-NS-RDC G13092  SCBR5.0-38-65-P-NS-RIM G11995  SCBR5.0-38-65-P-NS-SIM1 G12716  SCBR5.0-38-65-P-NS-SIM2 G23691  SCBR5.0-38-65-P-NS-TC G36320  SCBR5.0-38-65-P-NS-TC-BNK G36322  SCBR5.0-38-65-P-NS-TEGT G12179  SCBR5.0-38-80-P-NS-C2 G12006  SCBR5.0-38-80-P-NS-MPA G23692  SCBR5.0-38-80-P-NS-RH G36214  SCBR5.0-38-80-P-NS-VS G13431  SCBR5.0-38-80-P-NS-VS1 G13432  SCBR5.0-38-80-P-NS-VS2 G13433  SCBR5.0-38-80-P-NS-VS3 G13434  SCBR5.5-35-60-P-NS-PATEL G51570  SCBR6.5-35-60-P-NS-PATEL G51571",
      "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": "Slip-Cath Beacon Tip Catheter  Catheter, Intravascular, Diagnostic  The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.",
      "report_date": "20160831",
      "classification": "Class II",
      "openfda": {},
      "recalling_firm": "Cook Inc.",
      "recall_number": "Z-2614-2016",
      "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"
    }
  ]
}