Notes

Avanos Medical faces Class I recalls due to feeding tube system connection up to 23 deaths.

After seven years of unlucky luck for the Enteral Feeding Tube Placement System, the FDA has given its most severe designation for a recall of the device.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a display monitor as well as an electronic receiver. When they are used together, the system offers an live stream of the process of inserting a medical feeding tube into the stomach of a patient or into their small bowel with an aim of improving the accuracy of the tube's tip placement and reducing the risk of complications.

Avanos launched an earlier year, affecting all Cortrak*2 units which were in use between January 2021 and January 2022. It was nearly 630 devices. The devices were first distributed between April 2016 and the beginning of the year.

The safety event does not mean that there is a recall. Avanos has asked healthcare providers not to return the devices to the manufacturer. Avanos only wants to ensure that the devices are utilized correctly.

A feeding tube that is not properly placed could result in damage to the vocal cords, lungs, or trachea. https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/ This can lead to serious injury, or even death. Avanos has reported more than 60 injury cases since 2015, according to FDA. All of this was due to FDA's Cortrak*2 system, which guides placement of feeding tubes.

These injuries could include respiratory insufficiency, collapsed lungs, lung infection, as well as holes within the walls of the lungs and esophagus.

The FDA issued a March 21 field correction notice in which the Georgia-based company reminded users to verify the positioning of nasogastric tube and the nasoenteric pipe according to institution policies. Cortrak 2 eternal access system Avanos has requested that users include a safety note in their operating manuals and verify they have received the updated.

Avanos has announced that they will shortly issue a updated labeling for its product. This will include instructions for locating the position of the tube according to their facility's policies.

https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas This is the second caution that the FDA has issued this year with regard to the use of enteral feeding tubes. In February, FDA issued a safety advisory to healthcare providers and parents regarding the dangers of strangulation among children who use feeding tubes.

Following two deaths in 2021 the notice was issued. Avanos Medical Every time, a tube system was accidentally wrapped around a child who was less than two years old while they were not closely observed by the hospital staff or caregivers.

"While FDA believes strangulation of children with enteral feeding tubes in children is extremely rare, caregivers and healthcare providers should be aware of the fact that these events could and do occur," the FDA said in the announcement. The FDA also suggested that the FDA has not yet received any reports about similar cases.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
Website: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/