Notes

Avanos Medical faces a Class I recall of its the feeding tube system that was linked to 23 deaths that occurred in 2015

After seven years of adversity for the Avanos Medical Enteral Feeding Tube Placement System The FDA has handed down its most serious designation for a recall of the device.

The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as an LCD monitor. The system allows you to monitor the actual position of a medical feeding tube inside a patient's stomach.

https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Despite this mission it has been implicated in dozens of patient injuries, leading Avanos to launch a recall earlier this year of all Cortrak*2 devices used between January 2021 and January 2022, totalling around 630 devices initially released between April 2016 and the start of this year.

The safety event doesn't constitute an recall in the strictest sense: Avanos doesn't ask healthcare professionals to request that the device be returned to the maker. It's simply to make sure that they're using the device in a safe manner.

A feeding tube that is not properly placed can cause harm to vocal cords as well as lungs. It can also result in grave injury or even death. Avanos reported the number of injuries to patients and deaths to patients since 2015, FDA stated. Avanos Medical feeding tube All of these were connected to the FDA's Cortrak*2 device used to insert the feeding tube.

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

The FDA issued a March 21 field correction notice that the Georgia-based firm urged users to verify the location of nasogastric tubes as well as nasoenteric pipes according to institutional policies. Avanos asked that patients attach the safety notice and verify with Avanos that they've been updated.

Avanos announced that it will shortly release a new labeling system for the device. It will contain the directions to map out the location of the tube in line the policies of their facility prior to making use of the system to assist to install the tube.

The FDA has issued a second warning in relation to feeding tubes for enteral nutrition. In February, the agency issued an safety message to inform healthcare professionals and parents of the possibility of strangulation when children use feeding tubes.

The notice was issued as a result of two deaths in 2021. In each instance, a tubing system was discovered to have inadvertently wrapped around the neck of a patient younger than 2 when they weren't directly observed by their medical staff or caregivers.

Avanos Medical "While FDA believes strangulation of children who have enteral feeding set tubes is uncommon in children, caregivers and healthcare providers must 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.

https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns Cortrak 2 eternal access system
Here's my website: https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/