Z-2615-2016Class II

FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of...

Name: Z-2615-2016 FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of...
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 FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for... 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-2615-2016
Classification: Class II
Status: Terminated
Initiated: 2016-04-15
Posted: 2016-08-22
Terminated: 2017-08-04
Recalling firm: Cook Incorporated
Product: FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used for instillation of contrast media into the uterine cavity for radiographic evaluation of the uterine cavity and for injection of appropriate contrast media into the fallopian tubes for evaluation of tubal patency.
Product code: LFK Catheter, Femoral
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: 1,881
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/product number; Global/order number J-RTAS-100 G51608

Enforcement reports

One row per recalled product line

FDA enforcement reports joined to recall event Z-2615-2016
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 LFK

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 2026-09-30, the FDA export date for this dataset. Page last changed 2026-09-05. View this recall on fda.gov (opens on fda.gov)