Device Recall Beacon Tip Royal Flush Plus HighFlow Catheter

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

Cardiovascular Devices

2

No

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.

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.