Z-2611-2016Class II

Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended...

Name: Z-2611-2016 Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended...
Creator: Cook Inc.
Published: 2016-04-15
License: https://open.fda.gov/license/

Cook Incorporated / initiated 2016-04-15 / Terminated

FDA source

Cook Inc. began a recall of Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians... on 2016-04-15. FDA classified it as Class II and gives the reason as "Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical...". As of 2026-09-10, the recall status on record is Terminated.

Recall record

Recall number: Z-2611-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-08-22
Terminated: 2017-08-04
Recalling firm: Cook Incorporated
Product: Beacon Tip Royal Flush Plus High-Flow Catheter Catheter, Intravascular, Diagnostic The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.
Product code: DQO Catheter, Intravascular, Diagnostic
Reason for recall: Increase in reports of polymer degradation of the catheter tip, resulting in tip fracture and/or separation. degradation could include loss of device function, separation of a device segment leading to medical intervention, or complications resulting from a separated segment. Such complications include device fragments in the vascular system, genitourinary system, or other soft tissues. Fragments within the vascular system could result in embolization to the heart or lungs, or occluding blood flow to end organs.
FDA root cause: Unknown/Undetermined by firm
Action: Cook Inc. sent an URGENT: MEDICAL DEVICE RECALL NOTIFICATION letter dated April 15, 2016, to all affected customers. The recall notification included a description of the reason for the recall, affected product, consignee responsibilities, and instructions for responding to the formal recall notification. Customers with any medical questions or concerns, were instructed to contact Cook Medical Customer Relations at 800.457.4500 or 812.339.2235. For information regarding the recall, please contact Stericycle Expert Solutions at 866.201.9067.
Quantity in commerce: 532,395
Distribution: Worldwide Distribution - US (Nationwide) and Internationally to Algeria, Andorra, Argentina, Armenia, Australia, Austria, Bahrain, Bangladesh, Barbados, Belgium, Bermuda, Brazil, Brunei Darussalam, Bulgaria, Canada, Canary Islands, Chile, China, Colombia, Costa Rica, Cyprus, Czech Republic, Denmark, Djibouti, Dominican Republic, Ecuador, Egypt, El Salvador, Finland, France, French Polynesia, Georgia, Germany, Greece, Guadeloupe, Guatemala, Guernsey, Honduras, Hong Kong, Hungary, Iceland, India, Indonesia, Iran, Iraq, Ireland, Israel, Italy, Jamaica, Japan, Jersey, Jordan, Kazakhstan, Kenya, Korea, Kosovo, Kuwait, Latvia, Lebanon, Libyan Arab Jamahiriya, Lithuania, Luxembourg, Macau, Malaysia, Malta, Martinique, Mauritius, Mexico, Monaco, Mongolia, Morocco, Myanmar, Netherlands, Netherlands Antilles, New Caledonia, New Zealand, Nicaragua, Norway, Oman, Pakistan, "Palestinian Territory, Occupied", Panama, Paraguay, Peru, Philippines, Poland, Portugal, Puerto Rico, Qatar, Reunion, Romania, Russian Federation, Saudi Arabia, Serbia, Singapore, Slovakia, Slovenia, South Africa, Spain, Sri Lanka, Sweden, Switzerland, Taiwan, Thailand, Trinidad And Tobago, Tunisia, Turkey, Ukraine, United Arab Emirates, United Kingdom, Uruguay, Venezuela, Vietnam, U.S. Virgin Islands, Yugoslavia.
Product codes and lots: All Lots. Catalog prefixes HNR5.0 Catalog/product number; Global/order number HNR5.0-35-100-P-10S-0 G09697 HNR5.0-35-100-P-10S-CFP G11264 HNR5.0-35-100-P-10S-PIG G09059 HNR5.0-35-100-P-8S-VCF G31403 HNR5.0-35-100-P-NS-0 G10313 HNR5.0-35-100-ST-10S-0 G09565 HNR5.0-35-100-ST-10S-PIG G09525 HNR5.0-35-110-P-10S-0 G11241 HNR5.0-35-110-P-10S-PIG G11265 HNR5.0-35-65-P-8S-VCF G12129 HNR5.0-35-70-P-10S-0 G09411 HNR5.0-35-70-P-10S-CFP G11262 HNR5.0-35-70-P-10S-PIG G08832 HNR5.0-35-70-P-10S-PIG-RICKETTS-081983 G11280 HNR5.0-35-70-P-4S-PED G11281 HNR5.0-35-70-P-NS-0 G11959 HNR5.0-35-70-ST-10S-0 G09564 HNR5.0-35-70-ST-10S-PIG G09050 HNR5.0-35-80-P-8S-NEFF-CANADA-082098 G11860 HNR5.0-35-90-P-10S-0 G09412 HNR5.0-35-90-P-10S-CFP G11266 HNR5.0-35-90-P-10S-PIG G09408 HNR5.0-35-90-P-10S-PIG-RICKETTS-081983 G11282 HNR5.0-35-90-P-6S-PED G11729 HNR5.0-35-90-P-8S-VCF G12799 HNR5.0-35-90-ST-10S-0 G11641 HNR5.0-35-90-ST-10S-PIG G09197 HNR5.0-38-100-P-10S-0 G11267 HNR5.0-38-100-P-10S-CFP G11268 HNR5.0-38-100-P-10S-PIG G09285 HNR5.0-38-100-P-NS-0 G27874 HNR5.0-38-110-P-10S-0 G09461 HNR5.0-38-110-P-10S-PIG G11269 HNR5.0-38-70-P-10S-0 G11270 HNR5.0-38-70-P-10S-CFP G11271 HNR5.0-38-70-P-10S-PIG G11272 HNR5.0-38-70-P-NS-0 G11289 HNR5.0-38-80-P-10S-OPC G27877 HNR5.0-38-90-P-10S-0 G11273 HNR5.0-38-90-P-10S-CFP G11274 HNR5.0-38-90-P-10S-PIG G11275

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2611-2016
Recall number	Class	Status	Voluntary or mandated	Report date	Classified
Z-2610-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2611-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2612-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2613-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2614-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2615-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2616-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2617-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2618-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2619-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2620-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2621-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2622-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22
Z-2623-2016	Class II	Terminated	Voluntary: Firm initiated	2016-08-31	2016-08-22

Product code DQO

The FDA recall record names no cleared device, and no clearance has been matched to it.

MDM coverage of this record lists here, newest first.

About this record

Sourced from the FDA device recall database and the FDA enforcement reports, both ingested from openFDA. The recall record supplies the product, the reason and the product code; the enforcement report supplies the classification. The two datasets are exported by FDA on different days, and the date above is the older of the two, so nothing on this page is newer than it says.

MDM adds the root cause tag, derived from FDA’s own root cause text, and the cross-links to the product code, the clearances named on the record and MDM coverage. Where a recall has not been joined to an enforcement report, no classification is shown.

Data as of 2026-10-14, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)