Notes

Avanos Medical is facing a Class I recall due to feeding tube system malfunctions that have led to the deaths of 23 patients since the year 2015.

After seven years during which Avanos Medical's tube placement device was plagued by unlucky luck and a lack of trust, the FDA has issued its most serious instruction for a recall.

Avanos Mediacal Cortrak 2 Cortrak*2 Enteral Access System has an electromagnetic stylet as well as an external receiver. It also comes with an LCD monitor. When they are used together the system provides an live stream of the positioning of a medical feeding tube into the stomach of a patient, or in the small bowel, with an intention of improving the accuracy of the tube's placement and reducing the risk of complications.

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

RELATED
A tiny device, which promises greater safety, creates chaos for tube feeders
The safety incident is not considered to be a recall. Avanos has asked healthcare providers to not send the devices back at the expense of the manufacturer. However, they want to make sure that they are using the devices.

Avanos Medical feeding tube An incorrectly placed feeding tube can cause harm to vocal cords as well as lungs. Cortrak 2 eternal access system It could also cause severe injury or death. Avanos has reported more than 60 injury cases since 2015 according to the FDA. All of this was due to the FDA's Cortrak*2 system which directs the how to insert feeding tubes.

The injuries reported include respiratory failure and collapsed lung, lung infection the pleural effusion and holes in the lung's walls, esophagus and bowel.

According to FDA in its March 21 field correct notice, the Georgia-based firm reminded users to "confirm the placement of nasogastric and nasaloenteric pipes according to institution policies". Avanos Mediacal Cortrak 2 Avanos has also asked them to attach the safety note to the operating guideline of the system and confirm that they have received the updated.

Avanos announced that they would soon issue an updated labeling for the device. It will include the direction to place a tube according to their guidelines.

Avanos Mediacal Cortrak 2 RELATED
FDA asks Philips to repair, replacement, or refund on all ventilators that were removed from the market.
http://b3.zcubes.com/v.aspx?mid=8601821 Cortrak 2 eternal access system This is the second caution the FDA has issued this year with regard to enteral feeding tubes. The FDA issued an safety message in February warning healthcare professionals and parents about the risk of strangulation when children are feeding tubes.

Following two reports of deaths that occurred in 2021, the notification was sent. In each case, a tubing system was found to have inadvertently wrapped around the neck of a child who was less than two years old when they weren't directly observed by their medical staff or caregivers.

"While the FDA believes that strangulation from enteral feeding tube tubing in children is not likely to cause fatal injury or death Healthcare providers and caregivers must be aware of the possibility," the FDA stated in the notice. It also suggested that other similar cases might not have been reported yet to the FDA.


Read More: https://canvas.instructure.com/eportfolios/1339787/Home/Avanos_Recalls_Cortrak2_Over_Potential_Enteral_Tube_Misplacement