Notes

Avanos Medical is being recalled for the feeding tube system that was implicated in 23 deaths between 2015 and 2015.

After seven years of Avanos Medical's tube placement system was plagued by bad luck and a lack of trust, the FDA handed out its most serious order to recall the product.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an outside receiver, and a screen. When combined, the system gives a live stream of the medical feed tube being placed in the stomach of the patient.

In spite of that task, it has been linked to a number of patient injuries, leading Avanos to issue an recall earlier in the year of all Cortrak*2 devices used between January 2021 and January 2022--totaling nearly 630 devices first released between April 2016 and the beginning of this year.

The safety event isn't a recall in the literal sense: Avanos is not asking healthcare professionals to send the device back to its manufacturer, but rather to ensure they're using them correctly.

Incorrectly inserting a feeding tube could result in damage to the vocal cords, lungs, or trachea. https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ This could lead to serious injury, or even death. Avanos was notified of 23 deaths and 60 injuries in the year 2015 by the FDA. These events were all related to the Cortrak*2 system that guides the placement of the feeding tube.

There are many injuries that have been documented which include respiratory failure, lung infections and collapsed lung.

In its March 21 field correction notice, the Georgia-based company reminded users to "confirm placement of nasogastric and Nasoenteric tubes as per guidelines of the institution" according to the FDA. Avanos is advising users to add a safety warning to their operating manuals and verify that they have received the latest.

Avanos Medical Avanos announced that they will soon issue an updated labeling for the device. The label will contain the direction to place a tube according to their guidelines.

This is the FDA’s second warning regarding feeding tubes for enteral nutrition. In February, the FDA released an safety announcement warning healthcare providers and parents about the danger of strangulation in children who use feeding tubes.

The notice came after two deaths reported in 2021. In both cases, a tubing device was discovered be wrapped around the neck of a patient who was less than two years old, while they were not supervised by their caregivers or hospital personnel.

Cortrak 2 eternal access system https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/ "While the FDA believes that strangulation by tubes for feeding through the gastrointestinal tract in children is not common," the agency noted in the notice. Avanos Medical It also suggested that similar incidents may not have been reported yet to the FDA.


Website: https://www.yourlawyer.com/lawsuits/avanos-medical-recalls-the-cortrak2-enteral-access-system/