Home / Recalls / Cook Inc. / Z-2318-2015

Z-2318-2015 Class I Terminated

Recalled by Cook Inc. — Bloomington, IN

FDA device recall Z-2318-2015 was initiated by Cook Inc. on Jul 2, 2015 and is designated Class I. 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… The recall status is terminated (terminated Sep 2, 2017). Affected quantity: 268169.

Recall Details

Product Type: Devices
Report Date: Aug 12, 2015
Initiation Date: Jul 2, 2015
Termination Date: Sep 2, 2017
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 268169

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.

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.

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

Source

Dataset: openFDA device recall enforcement reports
FDA record: This recall in openFDA (JSON)
Enforcement Report: Search FDA's Enforcement Report for Z-2318-2015
openFDA file date: Oct 23, 2026
Loaded by RegDataLab: Oct 26, 2026

These dates say when openFDA published the data file and when RegDataLab last loaded it.

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