Notes

Avanos Medical faces Class I recalls in relation to 23 deaths related to the feeding tube system.

After seven years during which Avanos Medical's tube placement device was plagued by unlucky luck and a lack of trust, the FDA has given its most severe instruction to issue a recall.

Cortrak 2 eternal access system The Cortrak*2 Enteral Access System includes an electromagnetic stylet, an external receiver and a display monitor. The system is able to be combined to show a live stream that shows the process of inserting a medical feed tube in the stomach of a patient. Avanos Medical feeding tube This procedure is carried out to improve the accuracy of the procedure and decreasing complications.

Avanos announced a recall earlier this month of all Cortrak*2 device that were used between January 20,21 between January 20,22 and January 20,21. It involved nearly 630 devices.

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The safety incident is not considered to be a recall. Avanos has asked healthcare providers not to send the devices back to the expense of the manufacturer. But, they would like to make sure that they are using the devices.

A feeding tube that isn't correctly placed can result in severe injury or death. In fact, Avanos has received reports of deaths of 23 and 60 injuries since 2015, the FDA declared that all of them were related to the use of the Cortrak*2 system to aid in the installation of a feeding tube.

These injuries may be caused by respiratory failure, collapsed lungs, lung infection, pleural effusion and holes in the lungs' walls, esophagus, and bowel.

The FDA has reminded patients of the need to verify placement of nasogastric or nasoenteric tube in accordance with their institution policies in its March 21 field correction notification. Avanos is also asking them to add the safety notice to the operating manual for the device and verify that they have received the updated.

Avanos stated that it will soon release a revised labeling for its device. Cortrak 2 eternal access system This will include directions to indicate the location of the tube in line to their facility's policies.

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The FDA has issued a second warning about enteral feeding tube use. In February, the FDA issued a safety message informing parents and healthcare providers about the possibility of strangulation of children using feeding tubes.

Two deaths occurred in 2021 and were disclosed in the announcement. In both instances, a tubing system was accidentally tied around the neck of a child when they weren't being closely observed by caregivers or hospital staff.

"The FDA believes that death and serious injury caused by strangulation with tubing for feeding tubes used in the enteral system for children is rare. However, healthcare professionals and their caregivers should be aware that these events could and do occur," the FDA said in the announcement. The FDA suggested that similar instances could not yet be reported to the FDA.


Website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015