CLASS II Device recall · Reported 31 Aug 2016 · FDA Enforcement Report

FluoroSet Radiographic Tubal Assessment Set Cannula recalled by Cook

Cook is recalling FluoroSet Radiographic Tubal Assessment Set Cannula, Manipulator/ Injector, Uterine Used, distributed nationwide in the US. The recall was initiated on 15 Apr 2016 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesAll Lots. Catalog/product number; Global/order number J-RTAS-100 G51608

Quantity recalled1,881

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

Recall details

Recall number: Z-2615-2016
FDA event ID: 74010
Recalling firm: Cook, Bloomington, IN
Classification: Class II
Status: Terminated
Recall initiated: 15 Apr 2016
FDA classified: 22 Aug 2016
Reported: 31 Aug 2016
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Device type: Heart & Vascular Devices

Timeline

15 Apr 2016	Recall initiated by company
22 Aug 2016	Classified by FDA	+129 days
31 Aug 2016	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

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.

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

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.

Nationwide Georgia Puerto Rico

Questions about this recall

Why was it recalled?

Which lots are affected?

All Lots. Catalog/product number; Global/order number J-RTAS-100 G51608

Where was it sold?

What should I do if I have it?

Stop using the device if the notice says to, and contact the manufacturer or your healthcare provider for the correction or replacement.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

13 other products · FDA event 74010

This product is part of a recall event; the main page for the event is Neff DAgostino Percutaneous Access Set Accessories recalled by Cook.

Reported	Class	Recall	Company	Reason	Where
31 Aug 2016	CLASS II	Neff DAgostino Percutaneous Access Set Accessories recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Aprima Access Nonvascular Introducer Set Accessories recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Shuttle Select Slip-Cath Catheter, Intravascular recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Beacon Tip Royal Flush Plus High-Flow Catheter recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Beacon Tip Torcon NB Advantage Catheter, Intravascular, Diagnostic recalled	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Kumpe Access Catheter Cathether, Ureteral recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Haskal Transjugular Intrahepatic Portal Access Set recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Beacon Tip Centimeter Sizing Catheter Beacon Tip White recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Liver Access and Biopsy Needle Set Biopsy needle kit recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Selective Salpingography Catheter with Beacon Tip Cannula recalled	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Slip-Cath Beacon Tip Catheter, Intravascular recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	Transluminal Biliary Biopsy Forceps Set Forceps, Biopsy recalled by Cook	Cook	Potency & Assay	Nationwide
31 Aug 2016	CLASS II	White Lumax Guiding Coaxial Catheter recalled by Cook	Cook	Potency & Assay	Nationwide

More recalls from Cook

All 349

Reported	Class	Recall	Company	Reason	Where
13 May 2026Device	CLASS I	Beacon Tip Centimeter Sizing Catheter RPN/GPN recalled	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Aurous Centimeter Sizing Catheter RPN recalled by Cook Incorporated	Cook	Device Malfunction	Nationwide
13 May 2026Device	CLASS I	Centimeter Sizing Catheter RPN N5.0-35-100-P-10S-Pig-csc recalled	Cook	Device Malfunction	Nationwide
15 Apr 2026Device	CLASS II	Medical Cook Staged Extubation Set: Reference recalled	Cook	Other	IN
15 Apr 2026Device	CLASS II	Medical Cook¿ Spectrum¿ Central Venous Catheter Tray: Reference recalled	Cook	Other	IN

Other Heart & Vascular Devices recalls

All 6,199

Reported	Class	Recall	Company	Reason	Where
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Soft PVC Right Angle recalled	Atrium Medical	Potency & Assay	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes: *Bardex¿ I.C recalled	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Products that contain the Pericare Wipes recalled by C.R. Bard	C.R. Bard	Other	Nationwide
16 Sep 2026Device	CLASS II	Getinge PVC Thoracic Catheter, Firm PVC Straight recalled	Atrium Medical	Potency & Assay	Nationwide