Notes

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

After seven years' of failures with Avanos Medical's Enteral Feeding Tube Placement System, the FDA has assigned the most serious category for recalls.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an exterior receiver, and a screen. When combined, the system gives a live stream of the medical feeding tube that is placed inside the stomach of the patient.

Avanos was not happy with the mission and launched a recall of all Cortrak*2 units between January 2021 & January 2022. The recall included approximately 630 units that were distributed between April 2016 and the beginning of the year.

The safety event does not constitute the occurrence of a recall. Avanos has asked healthcare providers to not return the devices to their manufacturers. Avanos only wants to make sure that the devices are properly used.

If a tube for feeding is not properly placed, it could harm the vocal cords, lungs or trachea, potentially leading to severe injury or even death. Avanos has reported the deaths of 23 people and 60 injuries cases since 2015 according to the FDA. This is all due to FDA's Cortrak*2 system, which directs placement of feeding tubes.

Avanos Medical feeding tube Cortrak 2 eternal access system A variety of injuries have been reported including respiratory failure (collapsed lung) lung infection and pleural effusion. These are holes in the walls, esophagus and the bowel.

According to FDA in its March 21 Field Correction Notice the Georgia-based business advised users to "confirm the placement of Nasogastric (and nasoenteric) tubes in accordance with the institution's policy." Avanos Medical feeding tube Avanos requested that users add the safety announcement to the operation manual of the system and confirm that they have notified Avanos that the change was received.

Avanos said it will soon provide updated labels for the device. Cortrak 2 eternal access system It will contain the directions to map out a tube's placement in accordance with their facility's policies before making use of the system to assist to install the tube.

This is the FDA’s second caution in relation to feeding tubes for enteral nutrition. The FDA issued the safety message in February, warning healthcare professionals and parents about the danger of strangulation if children are tubes for feeding.

The announcement came in the wake of two reports of death in 2021. Each case involved a tubing system that was placed around the neck of a newborn less than 2 years old, while the baby was not being watched by staff at the hospital.

Avanos Medical Cortrak 2 eternal access system "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 the possibility exists that such incidents could and may happen," the FDA said in its notice. The FDA also suggested that the FDA might not have received reports on similar cases.


Here's my website: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/