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.
Reported: August 12, 2015 Initiated: July 2, 2015 #Z-2318-2015
Product Description
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.
Reason for Recall
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
Details
- Recalling Firm
- Cook Inc.
- Units Affected
- 268169
- Distribution
- 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.
- Location
- Bloomington, IN
Frequently Asked Questions
What product was recalled? ▼
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.. Recalled by Cook Inc.. Units affected: 268169.
Why was this product recalled? ▼
Reports of catheter tip splits and or separation. Loss of device function, medical intervention to retrieve separated segment, or complications resulting from separated tip occluding blood flow to end organs may result.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on August 12, 2015. Severity: Critical. Recall number: Z-2318-2015.
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