Notes

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

After seven years in which Avanos Medical's tube placement device was plagued with bad luck and a lack of trust, the FDA has given its most severe directive to recall the product.

Cortrak*2 Enteral Access System features an electromagnetic stylet with an external receiver and an LCD monitor. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause When combined, provides live video of the medical feed tube being placed in the stomach of a patient.

Avanos was not pleased with the results and announced an recall of all Cortrak*2 units between January 2021 and January 2022. The recall covered more than 630 units that were distributed between April 2016 and the start of this year.

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The incident that caused the safety issue isn't an recall in the strictest sense. Avanos does not ask healthcare providers for the device to be returned to the manufacturer. It's simply to make sure that they're using the device in a safe manner.

Incorrectly inserting the feeding tube incorrectly can cause injuries to the vocal cords or lungs. Cortrak 2 eternal access system Avanos recorded more than 23 deaths and 60 injuries since 2015, FDA declared. All of them were connected to FDA's Cortrak*2 device used to insert a feeding tube.

There are a variety of injuries which have been reported like respiratory failure, collapsed lung, lung infection.

According to the FDA Georgia-based Avanos issued a field correction note that reminded users to confirm the position of nasogastric tubes as well as tubs for nasoenteric according to the institution's policies. Avanos Medical They've also been asked to attach the safety warning to the system's operating manual and verify with Avanos that they have received the latest version of the notice.

Cortrak 2 eternal access system Avanos has announced that they will soon issue a new label for its device. Cortrak 2 eternal access system The labeling will contain the direction to map a tube's location in accordance their facility policies.

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This is the second caution that the FDA has issued this year in relation to enteral feeding tubes. In February, the FDA released an safety announcement informing parents and health professionals of the possibility of strangulation resulting from the usage of tubes for feeding by children.

Avanos Medical Two deaths occurred in 2021 and were disclosed in the announcement. Cortrak 2 eternal access system In both cases, a tubing system was inadvertently wrapped around a child's neck when they weren't being closely watched by caregivers or hospital staff.

"The FDA believes that strangulation with enteral feed set tubing in children is uncommon, but healthcare professionals and caregivers have to be aware that such events can and do happen," the agency stated in its notice. Cortrak 2 eternal access system This suggests that similar instances may not have been reported to the FDA.


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