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

Seven years after unlucky luck for the Avanos Medical Enteral Feeding Tube Placement System The FDA has given the most serious of designations for the recall of the device.

Cortrak*2 Enteral Access System features an electromagnetic stylet that includes an external receiver, a display monitor and an electronic receiver. In combination, the system gives a live stream of the medical feeding tube being placed in the patient's stomach.

Avanos Medical Avanos was not pleased with the results and announced an immediate recall of all Cortrak*2 units used between January 2021 & January 2022. The recall covered nearly 630 devices distributed in total between April 2016 and the start of this year.

The safety event isn't a recall in the literal sense: Avanos is not asking healthcare professionals to send the device back to its manufacturer but rather to ensure they're using them correctly.

Incorrectly inserting a feeding tube can cause damage to the vocal cords, lungs or the trachea. Avanos Medical feeding tube This could result in serious injury, or even death. Avanos was informed of 23 deaths and 60 injuries in 2015 by the FDA. feeding tube placement These events were all linked to the Cortrak*2 system, which guides the installation of the feeding tube.

There are a variety of injuries reported which include respiratory failure, lung infections and collapsed lung.

In its March 21 field correction note, the Georgia-based business warned users to "confirm the use of nasogastric or Nasoenteric tubes in accordance with the policies of the institution," as per the FDA. Avanos Medical feeding tube Avanos advised that patients attach the safety notice and verify with Avanos they have been upgraded.

Cortrak 2 eternal access system Avanos announced that it will shortly issue a revised labeling for its device. It will also include instructions to map the placement of the tube according to the guidelines of their facility.

This is the second FDA warning this year regarding enteral feeding tubes. In February, the FDA put out a safety message informing healthcare professionals and parents of the possibility of strangulation when children are using feeding tubes.

This notice was issued due to two deaths reported in 2021. Each incident was a result of a tubing system which was accidentally tied around the neck of a baby younger than 2 when the baby was not being watched by hospital staff.

"While the FDA believes that strangulation caused by enteral feeding tube tubing in children is not common," the agency noted in the announcement. Avanos Mediacal Cortrak 2 It also suggested that similar cases may not have been reported to the FDA.


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