Device Recall Beacon Tip Royal Flush Plus HighFlow Catheter

  • Modelo / Serial
    All lots of the following Product numbers: HNR4.0-35-100-P-10S-0,  HNR4.0-35-100-P-10S-CFP,  HNR4.0-35-100-P-10S-PIG,  HNR4.0-35-100-P-6S-VCF,  HNR4.0-35-100-P-NS-0, HNR4.0-35-100-P-NS-DAV,  HNR4.0-35-100-P-NS-SIM1,  HNR4.0-35-100-P-NS-SIM2,  HNR4.0-35-100-ST-10S-0, HNR4.0-35-100-ST-10S-PIG,  HNR4.0-35-100-ST-6S-PED,  HNR4.0-35-110-P-10S-PIG,  HNR4.0-35-120-P-6S-PED, HNR4.0-35-120-ST-6S-PED,  HNR4.0-35-125-P-10S-0,  HNR4.0-35-125-P-10S-PIG,  HNR4.0-35-50-P-NS-0,  HNR4.0-35-65-P-8S-VCF, HNR4.0-35-70-P-10S-0,  HNR4.0-35-70-P-10S-CFP,  HNR4.0-35-70-P-10S-PIG,  HNR4.0-35-70-P-4S-PED,  HNR4.0-35-70-P-6S-PED, HNR4.0-35-70-P-NS-0,  HNR4.0-35-70-ST-10S-0,  HNR4.0-35-70-ST-10S-PIG,  HNR4.0-35-70-ST-6S-PED,  HNR4.0-35-90-P-10S-0, HNR4.0-35-90-P-10S-CFP,  HNR4.0-35-90-P-10S-PIG,  HNR4.0-35-90-P-6S-PED,  HNR4.0-35-90-P-8S-VCF,  HNR4.0-35-90-P-NS-0, HNR4.0-35-90-ST-10S-0,  HNR4.0-35-90-ST-10S-PIG
  • Clasificación del producto
  • Clase de dispositivo
    2
  • ¿Implante?
    No
  • Distribución
    Worldwide Distribution - US (nationwide including Puerto Rico and US Virgin Islands), Algeria, Antigua, Armenia, Austria, Australia, Bahamas, Belgium, Bangladesh, Bulgaria, Bahrain, Brazil, Brunei Darussalam, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Dominican Republic, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Ghana, Great Britain, Greece Guadeloupe, Hong Kong, Hungary, Iceland, India, Indonesia, Iraq, Ireland, Israel, Italy, Japan, Jersey, Jordan, Kuwait, Kazakhstan, Republic of Korea, Kuwait, Lebanon, Lithuania, Luxemburg, Latvia, Libya, Macau, Malaysia, Malta, Martinique, Mexico, Mongolia, Morocco, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, Panama, Paraguay, Peru, Philippines, Poland, Portugal, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Sri Lanka, Sweden, Switzerland, Spain, Taiwan, Thailand, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, and Vietnam.
  • Descripción del producto
    Beacon Tip Royal Flush Plus High-Flow Catheter. Angiographic catheter. || For use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.
  • Manufacturer
  • 1 Event

Fabricante

  • Dirección del fabricante
    Cook Inc., 750 N Daniels Way, Bloomington IN 47404-9120
  • Empresa matriz del fabricante (2017)
  • Source
    USFDA