Notes

Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths since 2015

Seven years after unlucky luck for the Avanos Medical enteral feeding tube system The FDA has issued its most serious designation for a recall of the device.

Cortrak*2 Enteral Access System has an electromagnetic stylet and an external receiver. It also has the capability of displaying a screen monitor. The system can be combined to provide a live feed that shows the process of inserting a medical feeding tube in the stomach of an individual. The procedure is performed to improve precision and reducing the risk of complications.

Avanos has announced a recall earlier this month of every Cortrak*2 device that was that were used between January 20,21 and January 20,22. Avanos Medical feeding tube It affected more than 630 devices.

RELATED
A tiny widget can provide more safety, but can cause chaos within tube feeders.
Avanos Medical The safety event is not a recall in its literal sense: Avanos does not ask medical professionals to return devices back to the manufacturers. Instead, it wants to make sure they're using the devices correctly.

Cortrak 2 eternal access system A feeding tube that is not properly placed can cause harm to vocal cords as well as lungs. It may also cause severe injury or death. In actual fact, Avanos has received reports of 23 deaths and 60 injuries since the year 2015, the FDA stated all of which were related to the use of the Cortrak*2 system to aid in the placement of a feeding tube.

Cortrak 2 eternal access system These injuries could include respiratory failure, collapsed lungs, lung infection, pleural effusion and holes in the walls lungs, esophagus, and bowel.

In the March 21 field correction notice, the Georgia-based company advised users to "confirm the placement of nasogastric as well as Nasoenteric tubes as per the policies of the institution," per the FDA. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos also requested that users attach the safety notice and verify with Avanos they received the updated.

Avanos indicated that it will shortly issue new labels to the device. These will include the instructions for where to put the tube, in accordance with the company's policies.

RELATED
FDA requires Philips to fix, replace or pay for all recalls of ventilators
The FDA has issued a second warning of the year for enteral feeding tubes. The FDA issued a safety announcement in February warning healthcare professionals and parents about the risk of strangulation when children are using feeding tubes.

Following two reports of deaths in 2021, the notice was sent. In both cases, a tubing system was tied around the neck of a child while they were not being closely monitored by the hospital staff or caregivers.

"The FDA believes that strangulation via tubing for feeding through the enteral system in children is uncommon, but healthcare professionals and caregivers have be aware that such incidents can happen," the agency stated in the announcement. This suggests that similar instances could not have been reported to the FDA.

feeding tube placement
Homepage: https://www.raps.org/regulatory-focus%E2%84%A2/news-articles/2018/1/fda-warns-doctors-of-collapsed-lungs-and-deaths-possibly-linked-to-feeding-tube-placement-devices