The Recall Desk
SevereFDA (Devices)·Z-2615-2016·Announced 2016-08-31

Cook Inc. Recalls FluoroSet Radiographic Tubal Assessment Sets

Cook Inc. is recalling 1,881 FluoroSet Radiographic Tubal Assessment Sets due to polymer degradation that can cause catheter tip fracture or separation.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II and involves a risk of significant injury, including potential embolization or occlusion of blood flow from device fragments.

Plain-English summary

Cook Inc. is recalling 1,881 units of the FluoroSet Radiographic Tubal Assessment Set, catalog number J-RTAS-100 G51608. The recall covers all lots and includes worldwide distribution to the United States and numerous international locations. The device is used for radiographic evaluation of the uterine cavity and fallopian tubes.

The recall is being conducted due to an increase in reports of polymer degradation at the catheter tip, which can result in tip fracture or separation. This degradation can lead to loss of device function or the separation of a device segment, potentially requiring medical intervention. Complications from separated segments may include fragments in the vascular system, genitourinary system, or other soft tissues, which could result in embolization or occlusion of blood flow.

Healthcare providers and facilities that have used or possess these devices should stop using them and contact Cook Inc. for instructions on return or replacement. Patients who have had this procedure should contact their healthcare provider if they experience symptoms consistent with device complications.

The recalled product

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 eva
Manufacturer
Cook Inc.
Category
Medical Device — Radiographic Catheter
Hazard
Affected units
1,881

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

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

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

Part of a larger recall action

This product is one of 14 recalled by Cook Inc. under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 14 products in this recall →

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Same hazard · device fracture

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