Notes

Avanos Medical faces Class I recall for feeding tube system implicated in 23 deaths since 2015

Seven years after bad luck for Avanos Medical's enteral feeding tube system The FDA has issued the most serious of designations for a recall of the device.

Cortrak*2 Enteral Access System contains an electromagnetic stylet as well as an external receiver. Avanos Medical feeding tube It provides a continuous stream of medical tube feeding being placed in patients' stomachs or small bowels. This allows for improvement of tip placement accuracy and the reduction of complications.

Avanos issued an earlier this month a recall of all Cortrak*2 devices that were used between January 20,21 between January 20,22 and January 20,21. It involved nearly 630 devices.

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The safety incident is not an issue of recall. Avanos doesn't ask healthcare providers send the devices back, but to ensure that they are using them in a safe manner.

Incorrectly inserting a feeding tube can cause damage to the vocal cords, lungs or trachea. This can lead to serious injury, or even death. Avanos has reported 60 injuries and 23 deaths in the last year, FDA stated. All of them were connected to FDA's Cortrak*2 device used to insert the feeding tube.

Many different injuries have been described, such as respiratory failure (collapsed lung) lung infection, holes in the walls and esophagus.

The FDA has reminded patients that they must confirm the placement of a nasogastric or nasoente tube according to their institution guidelines in its March 21 field correction notice. Avanos Medical feeding tube Avanos is requesting that users attach a safety notice to their operating manual and to confirm that they've been updated.

Avanos announced that it will soon release a revised labeling for its product. Avanos Medical feeding tube This will include directions to indicate the location of the tube in line to their facility's policies.

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This is the second FDA warning this year regarding enteral feeding tubes. Avanos Medical In February, the agency issued an safety message informing healthcare professionals and parents of the possibility of strangulation when children use feeding tubes.

In the wake of two deaths in 2021, the notice was sent. The notice came in the wake of two reports of death in 2021. Cortrak 2 eternal access system In each instance the tubing system was discovered to have been wrapped around the necks of patients younger than age of 2.

"The FDA believes that strangulation via enteral feed set tubing children is uncommon, but healthcare providers and caregivers need be aware that such instances can occur and can happen," the agency stated in the announcement. This suggests that similar instances might not have been reported to FDA.


Website: https://aacnjournals.org/ajcconline/article/26/2/149/3230/Cortrak-Assisted-Feeding-Tube-Insertion-A