Notes

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

Seven years after unlucky luck for the Avanos Medical enteral feeding tube placement device The FDA has handed down its most serious designation for recalls of the product.

Avanos Medical feeding tube The Cortrak*2 Enteral Access System includes an electromagnetic stylet with an external receiver as well as a display monitor. When combined, the system allows you to view the live installation of a medical feed tube inside the stomach of a patient.

Despite that goal it has been linked to dozens of patient injuries which led Avanos to launch an recall earlier in the year of all Cortrak*2 units used between January 2021 to January 2022. This totals around 630 devices initially distributed between April 2016 until the beginning of this year.

Cortrak 2 eternal access system RELATED
A tiny widget promises greater security, but it also causes chaos inside tube feeders
The safety incident is not a recall. Avanos doesn't ask healthcare providers to return the devices and to make sure they use them correctly.

Cortrak 2 eternal access system If a tube for feeding is incorrectly inserted it could cause damage to the vocal cords, lungs, or trachea, potentially leading to grave injury or even death. Avanos Medical Avanos recorded 60 injuries and 23 deaths in 2015, the FDA declared. All of these were related to the FDA's Cortrak*2 system that is used to insert the feeding tube.

There are several injuries which have been reported like respiratory failure, collapsed lung, and lung infections.

According to FDA the Georgia-based company advised users in the March 21 Field Correction Notice to "confirm the placement of nasogastric and nasoenteric tubes according to institutional guidelines". Avanos recommended that patients attach the safety notice and confirm with Avanos they received the revised notice.

Avanos has announced that they will soon release a new label for its device. The labeling will be able to include the direction for mapping the tube's location, in accordance with their policies for their facilities.

RELATED
FDA will issue an order requiring Philips to fix or replace or reimburse all ventilators that have been recalled.
The FDA has issued a second caution regarding the use of an enteral tube for feeding use. Cortrak 2 eternal access system https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ In February, the FDA issued a safety alert warning parents and healthcare providers about the possibility of strangulation in children who use feeding tubes.

https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/ The announcement followed two instances of death in 2021. In each instance, a tubing system was found to have inadvertently wrapped around the neck of a child who was less than two years old while they weren't being directly watched by the medical staff or caregivers.

"The FDA believes that strangulation by enteral feed set tubing children is rare, however, healthcare professionals and caregivers have be aware that these instances can occur and can occur," the agency stated in the notice. Cortrak 2 eternal access system Avanos Medical feeding tube This indicates that similar incidents may not have been reported to the FDA.


Homepage: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/