Notes

Avanos Medical faces Class I recalls for its feeding tube systems connected to 23 deaths in 2015.

After seven years of Avanos Medical's tube placement system was plagued with bad luck, the FDA gave its most serious directive for a recall.

Cortrak*2 Enteral Access System features an electromagnetic stylet, which includes an external receiver, a display monitor as well as an electronic receiver. The system provides a live feed of medical tubes that are inserted in patients' stomachs or small bowels. Cortrak 2 eternal access system Avanos Medical Cortrak 2 eternal access system This facilitates an improvement in tip placement precision and decrease of complications.

Avanos was not pleased with the results and announced a recall of all Cortrak*2 units used between January 2021 & January 2022. The recall included approximately 630 units which were distributed between April 2016 & the beginning this year.

The safety event isn't an actual recall, but rather a meaning: Avanos does not ask health professionals to return the devices to the manufacturer. Instead, it would like to ensure they are making use of the devices in a safe manner.

A feeding tube that is not properly placed could cause damage to vocal cords and the lungs. It could also cause grave injury or even death. Avanos was alerted of the deaths of 23 people and injuries to 60 in the year 2015 by the FDA. The incidents were all connected to the Cortrak*2 system that guides the positioning of the feeding tube.

These injuries could include respiratory insufficiency, collapsed lungs, lung infection, and holes in the walls of the lungs and the esophagus.

Avanos Medical feeding tube The FDA issued a March 21 field correction notice in which the Georgia-based company reminded users to verify the location of nasogastric tubes as well as Nasoenteric pipes in accordance with institutional policies. Avanos is advising users to add a safety warning to their operating manual and to confirm that they have received the latest.

Avanos Medical feeding tube Avanos announced that they would soon issue updated labeling to the device. The label will contain the directions to put tubes according to their guidelines.

This is the FDA's second warning regarding feeding tubes for enteral nutrition. In February, the FDA released a safety announcement to inform healthcare professionals and parents of the possibility of strangulation when children are using feeding tubes.

The announcement came in the wake of two deaths in 2021. Each of the cases included a tube that was placed around the neck of a child younger than 2 when the baby was not being watched by hospital staff.

"While the FDA believes that serious injury or death caused by strangulation from tubing for feeding through the enteral system in children is uncommon Healthcare providers and their caregivers must be aware that these events could and do happen," the agency said in its notice, suggesting that other similar incidents may not have been reported to the FDA.


Here's my website: https://biotech-insider.com/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/