Notes

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

After seven years during which Avanos Medical's enteral tube placement device was struck by unlucky luck, the FDA handed out its most severe directive for a recall.

Avanos Medical feeding tube Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also has a display monitor. When used together the system provides an live stream of the placement of an medical tube for feeding into a patient's stomach or small bowel with an goal of improving the precision of the tube's placement and reducing the chance of complications.

Avanos began a recall earlier in this year, involving all Cortrak*2 devices that was used between January 2021 and Jan 2022. There were more than 630 units originally distributed from April 2016 through the beginning.

The safety event isn't a recall , in the literal sense of the word: Avanos is not asking healthcare providers to send the devices back to the manufacturer but rather to ensure they're using the devices correctly.

A feeding tube that is not properly placed could cause injury to the vocal cords, lungs or trachea. This could result in severe injury or death. In fact, Avanos has received reports of 23 deaths and 60 injuries since the year 2015 The FDA said, all of which were related to the the Cortrak*2 system to guide the placement of a feeding tube.

The reported injuries include respiratory failure and lung infections, collapsed lung the pleural effusion and holes in the lungs' walls as well as the esophagus and bowel.

The FDA has reminded patients of the need to verify that they have placed a nasogastric tube in accordance with their institution guidelines in its March 21 field correction notice. They've also been instructed to add the safety note to the system's operating manual and verify with Avanos that they received the updated.

Avanos announced that it will soon issue new labeling guidelines for its device. It will also include instructions for locating the position of a tube according to the guidelines of their facility.

The FDA has issued a second warning on the use of enteral feeding tubes this year. In February, the FDA issued a safety alert to healthcare providers and parents about the risk of strangulation for children who are using feeding tubes.

The announcement came in the wake of two deaths in 2021. Avanos Medical Each case included a tube which was accidentally wrapped around the neck of a child less than 2 years old, while the baby was not being watched by hospital staff.

Avanos Medical feeding tube Cortrak 2 eternal access system "While FDA believes that death due to strangulation caused by tubing for feeding tubes used in the enteral system for children is extremely rare It is crucial that caregivers and healthcare providers are aware that such events could and do occur," the FDA stated in its notice. Cortrak 2 eternal access system The agency suggested that similar incidents might not yet have been reported.


Website: https://www.igj.nl/binaries/igj/documenten/waarschuwingen/2022/05/11/avanos-medical-fca-2022-002---cortrak-2-enteral-access-system-eas/IT2061269+Avanos+FCA-2022-002+-+Cortrak+2+Enteral+Access+System+(EAS).pdf