Notes

Avanos Medical faces Class I recall because of feeding tube system connection to 23 deaths.

After seven years during which Avanos Medical's tube placement device was struck by unlucky luck and a lack of trust, the FDA issued its most serious order to recall the product.

Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also has a display monitor. https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos Mediacal Cortrak 2 When combined the system provides an live stream of the placement of an medical tube for feeding into a patient's stomach or small bowel with an goal of improving the precision of the tube's placement and reducing the risk of complications.

Avanos has announced a recall earlier this month of all Cortrak*2 devices used between January 20,21 until January 20,22. The recall affected nearly 630 devices.

The safety event does not constitute an recall. Avanos Mediacal Cortrak 2 Avanos has asked healthcare providers to not return the devices to their manufacturer. https://escatter11.fullerton.edu/nfs/show_user.php?userid=2861198 Avanos only wants to ensure that the devices are being used correctly.

A feeding tube that is not properly placed could cause damage to vocal cords and the lungs. It may also cause severe injury or death. According to FDA, Avanos received reports of 23 deaths, and 60 injuries, as of 2015, all linked to the FDA's usage of the Cortrak*2 system for guiding the placement of a feeding tub.

There are several injuries that have been documented which include respiratory failure, lung infection and collapsed lung.

In the March 21 field correction notice, the Georgia-based company reminded users to "confirm placement of nasogastric and Nasoenteric tubes in accordance with institutional policies," per the FDA. Avanos asked that patients be sure to attach the safety announcement and confirm with Avanos that they've been up-to-date.

Avanos said it will soon provide updated labels for the device that will include a direction to map out the tube's location in accordance with their facility's policies before using the system to assist install the tube.

This is the second FDA warning this year about enteral feeding tubes. feeding tube placement The FDA issued the safety communication in February, warning parents and healthcare professionals about the risk of strangulation when children are feeding tubes.

Cortrak 2 eternal access system After two deaths in 2021 the notice was issued. feeding tube placement Avanos Medical In both instances the tubing device was discovered to have been inadvertently wrapped around necks of patients who were less than 2 years old while they were not supervised by hospital staff or caregivers.

"While FDA believes strangulation of children with enteral feeding set tubes in children is rare caregivers and healthcare professionals should be aware that such events can and will happen," the FDA said in its notice. They also suggested that the FDA might not have received any reports about similar cases.


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