Notes

Avanos Medical faces a Class I recall of its feeding tube system connected to 23 deaths in 2015

Seven years after adversity for the Avanos Medical enteral feeding tube placement device The FDA has given the most serious of designations for a recall of the device.

Avanos Medical feeding tube Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also includes a display screen monitor. When combined will provide live footage of the medical tube being placed into the stomach of a patient.

Avanos announced a recall earlier in the year for all Cortrak*2 devices which were in use between January 2021 and January 2022. This totaled nearly 630 devices. They were distributed for the first time between April 2016 until the beginning of 2016.

RELATED
A tiny widget offers more safety, but can cause chaos in tube feeders
The safety incident is not a recall in its literal sense: Avanos does not ask medical professionals to return devices to the manufacturer. Avanos Medical Instead, it would like to ensure they are using the devices correctly.

A wrongly placed feeding tube can damage vocal cords and lungs. It can also result in grave injury or even death. Avanos has reported the deaths of 23 people and 60 injuries cases in 2015 as per the FDA. All of this was due to FDA's Cortrak*2 system that guides the placement of feeding tubes.

Avanos Medical feeding tube The injuries reported include respiratory failure, lung infections, collapsed lung, pleural effusion, and holes in the walls of the lungs, esophagus and bowel.

The FDA has reminded patients that they must confirm the placement of a nasogastric or nasoente tube in accordance with their institution guidelines in the March 21 field correction notice. Avanos has also asked them to add the safety notice to the operating guideline of the device and verify that they have received the latest update.

Cortrak 2 eternal access system Avanos has stated that it will soon issue new labeling for its device. The labeling will contain the direction for mapping the location of the tube in line with their facility policies.

RELATED
FDA requires Philips to replace, fix or reimburse all recall ventilators
This is the second FDA warning on the use of enteral feeding tubes this year. feeding tube placement In February, the agency issued an safety message warning healthcare providers and parents about the danger of strangulation for children using feeding tubes.

https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas Two deaths in 2021 were disclosed in the announcement. Each time, the notice was followed by two deaths in 2021.

"The FDA believes that death and serious injuries resulting from strangulation using enteral feeding set tubing for children is extremely rare. However, healthcare providers, and caregivers, should be aware that these events could and do occur," the FDA said in its notice. The FDA suggested that similar instances could not yet be reported to the FDA.


Homepage: https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas