Cook Inc.: Medical Device Recall in 2015 - (Recall #: Z-2318-2015)

Updated on March 25, 2026.

See the recall detail below. You can also see other recalls from the same firm in 2015.

Data Source: FDA.

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.

Product Classification:

Class I

Date Initiated: July 2, 2015

Date Posted: August 12, 2015

Recall Number: Z-2318-2015

Event ID: 71692

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.

Status: Terminated

Product Quantity: 268169

Code Information:

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

Distribution Pattern:

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.

Voluntary or Mandated:

Voluntary: Firm initiated