The Recall Desk
SevereFDA (Devices)·Z-2621-2016·Announced 2016-08-31

Cook Inc. Recalls Selective Salpingography Catheters Due to Tip Fracture Risk

Cook Inc. is recalling 7,819 Selective Salpingography Catheters with Beacon Tip due to polymer degradation that can cause the catheter tip to fracture or separate.

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 structural defect (tip fracture/separation) that can lead to significant injury, such as embolization or occlusion of blood flow.

Plain-English summary

Cook Inc. is recalling 7,819 units of the Selective Salpingography Catheter with Beacon Tip, including the Cannula, Manipulator/Injector, and Uterine components. The device is used for the injection of contrast medium into the fallopian tubes for selective salpingography. The recall covers all lots, specifically catalog/product number J-SSG-504000 and global/order number G17868.

The recall is being conducted due to an increase in reports of polymer degradation of the catheter tip, which can result in tip fracture and/or separation. This degradation can lead to a loss of device function or the separation of a device segment, potentially requiring medical intervention. Complications from separated segments may include fragments remaining 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 occlude blood flow to end organs.

The affected devices were distributed worldwide, including nationwide in the United States and internationally to numerous countries. Consumers and healthcare providers should stop using the affected devices and contact Cook Inc. for further instructions on the recall.

The recalled product

Product
Selective Salpingography Catheter with Beacon Tip Cannula, Manipulator/ Injector, Uterine Used for injection of contrast medium into the fallopian tube(s) for selective salpingography.
Manufacturer
Cook Inc.
Category
Medical Device — Catheter
Hazard
Affected units
7,819

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-SSG-504000 G17868

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 →

Related recalls

Same manufacturer · Cook Inc.

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Same hazard · device fracture

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