Notes

Avanos Medical faces Class I recall due to feeding tube connection that led to 23 deaths.

The FDA has given the most severe of warnings for the recall of Avanos Medical's feed tube enteral positioning system.

Cortrak*2 Enteral Access System contains an electromagnetic stylet , as well as an external receiver. The system, when used together will provide live footage of the medical feed tube that is placed inside a patient's stomach.

Avanos was not satisfied with its mission and launched a recall of all Cortrak*2 units between January 2021 & January 2022. Avanos Mediacal Cortrak 2 The recall covered approximately 630 units that were distributed between April 2016 and the start of this year.

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The safety event isn't recall in its true meaning: Avanos does not ask health professionals to return the devices to the manufacturer. Instead, it would like to make sure they're making use of the devices in a safe manner.

https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause If a feeding tube is not properly inserted and is not properly inserted, it can cause damage to the vocal cords, lungs, or trachea and cause grave injury or even death. In actual fact, Avanos has received reports of more than 60 injuries since 2015, the FDA declared that all of them were related to the the Cortrak*2 system to aid in the placement of the feeding tube.

Avanos Medical Many different injuries have been described, which include respiratory failure (collapsed lung) as well as lung infections and holes within the esophagus's walls.

The FDA reminded users of the need to verify that they have placed a nasogastric tube in accordance with their institution policies in its March 21 field correction notice. Avanos requested that users add the safety announcement to the operation manual of the system and then confirm with Avanos that the change was accepted.

Avanos has announced that they will shortly issue a new labeling guidelines for its device. Avanos Mediacal Cortrak 2 This will include directions for locating the position of the tube in line to the policies of their facility.

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This marks the second warning the FDA has issued this year in relation to enteral feeding tubes. In February the FDA issued a safety advisory to parents and healthcare providers regarding the risk of strangulation to children who are fed through tubes.

The announcement followed two instances of death in 2021. In both instances the tubing system was accidentally wrapped around a child's neck while they were not being closely monitored by the hospital staff or caregivers.

"While the FDA believes that deaths or serious injuries resulting from strangulation with enteral food set tubing in children is rare healthcare professionals and caregivers should know that such events could and will happen," the FDA noted in the notice.


Homepage: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical