Notes

Avanos Medical faces Class I recalls for its feeding tube system associated with 23 deaths since 2015

The FDA has given its most severe warning in relation to the recall of Avanos Medical’s enteral feeding tube positioning system.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a monitor for display and an electronic receiver. The system can be used in conjunction to stream a live video which shows the process of inserting a medical feed tube into the stomach of an individual. This procedure is carried out with the aim of improving accuracy and reducing complications.

Cortrak 2 eternal access system Avanos issued an earlier in the month a recall of every Cortrak*2 device that was used between January 20,21 and January 20,22. It involved nearly 630 devices.

Avanos Medical feeding tube The safety incident isn’t a recall, in the literal sense. Avanos doesn’t ask healthcare providers to return the devices at the manufacturer. Avanos wants them to use the devices correctly.

An incorrectly placed feeding tube can damage vocal cords and the lungs. Avanos Medical It could also cause severe injury or death. Avanos has reported 23 deaths and 60 injury cases in 2015 as per the FDA. This was all due to FDA's Cortrak*2 system, which guides placement of feeding tubes.

The injuries reported include respiratory failure as well as collapsed lung, lung infection as well as pleural effusion. holes in the lung's walls, esophagus and bowel.

According to FDA, the Georgia-based company reminded users in its March 21 field safety notice to "confirm the use of tubs in nasogastric/nasoente to policies of the institution". Avanos has also asked users to attach the safety note to the operating manual for the device and to confirm that they have received the updated.

Avanos announced that they would soon issue an updated labeling for the device. The label will contain the instructions for placing a tube according to their guidelines.

The FDA has issued a second warning regarding enteral feeding tube use. Avanos Medical feeding tube In February, the agency issued a safety announcement informing healthcare professionals and parents about the danger of strangulation when children use feeding tubes.

The notice came after two deaths in 2021. Every time, a tubing system was wrapped around a child under two years of age while they were not watched by the hospital staff or caregivers.

"While FDA believes that death from strangulation using enteral feeding tubing used for children is rare, it's important that healthcare providers and caregivers are aware that such events occur," the FDA stated in the announcement. The agency also suggested that similar cases might not yet have been reported.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
Read More: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/