{
  "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": "60,302",
      "code_info": "All Lots.  Catalog prefixes/suffixes SCBR5.5-/-SHTL  SCBR6.5-/-SHTL    Catalog/product number; Global/order number  SCBR5.5-35-125-P-NS-H1-SHTL                      G31129  SCBR5.5-35-125-P-NS-JB1-SHTL                      G31130  SCBR5.5-35-125-P-NS-JB2-SHTL                      G36361  SCBR5.5-35-125-P-NS-MPA-SHTL                      G23697  SCBR5.5-35-125-P-NS-SIM1-SHTL G23699  SCBR5.5-35-125-P-NS-SIM2-SHTL G36360  SCBR5.5-35-125-P-NS-VERT-SHTL G23698  SCBR5.5-35-125-P-NS-VTK-SHTL                       G36359  SCBR5.5-35-135-P-NS-ANG-SHTL                       G48154  SCBR5.5-35-150-P-NS-0-SHTL                       G23705  SCBR5.5-35-150-P-NS-ANG-SHTL  G23704  SCBR5.5-35-75-P-NS-ANG-SHTL                       G48152  SCBR6.5-35-125-P-NS-H1-SHTL                       G31134  SCBR6.5-35-125-P-NS-JB1-SHTL                      G31135  SCBR6.5-35-125-P-NS-JB2-SHTL                      G36364  SCBR6.5-35-125-P-NS-SIM1-SHTL G23701  SCBR6.5-35-125-P-NS-SIM2-SHTL G36363  SCBR6.5-35-125-P-NS-VERT-SHTL G23700  SCBR6.5-35-125-P-NS-VTK-SHTL             G36362",
      "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": "Shuttle Select Slip-Cath  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-2613-2016",
      "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"
    }
  ]
}