Notes

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

The FDA has given its most severe warning in relation to the recall of Avanos Medical's Enteral Feeding Tube Positioning System.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an exterior receiver with an LCD monitor. It can be combined to provide a live feed which shows the process of inserting a medical feeding tube into the stomach of an individual. Cortrak 2 eternal access system This procedure is carried out in the hope of increasing accuracy and reducing complications.

Despite that goal it has been implicated in the occurrence of dozens of patient injuries which led Avanos to announce a recall in January of all Cortrak*2 devices between January 2021 to January 2022. This totals around 630 devices initially distributed between April 2016 and the start of this year.

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The safety issue is not an issue of recall. Avanos doesn't ask healthcare providers to return the devices, but to ensure that they use them properly.

Avanos Medical The incorrect placement of the feeding tube could cause damage to vocal cords or the lungs. In fact, Avanos has received reports of more than 60 injuries since 2015 the FDA stated all of which were linked to the use of the Cortrak*2 system to aid in the placement of the feeding tube.

Avanos Medical There are several injuries that have been reported like respiratory failure, collapsed lung, lung infection.

https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns According to the FDA Georgia-based Avanos issued a March 21 field correction notice reminding patients to verify the location of nasogastric tubes as well as nasoenteric tubs according to institutional policies. Avanos Medical Avanos has asked users to attach a safety notice to their operating manual and confirm they've updated their manuals.

Avanos announced that it will shortly issue a new labeling guidelines for its device. It will also include instructions for locating the position of the tube according to the policies of their facility.

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This marks the second warning the FDA has issued this year with regard to the use of enteral feeding tubes. The FDA released an safety announcement in February, warning healthcare professionals and parents about the risk of strangulation in the event that children are feeding through tubes.

Cortrak 2 eternal access system The notice was issued as a result of two deaths reported in 2021. Cortrak 2 eternal access system In both instances the tubing system was inadvertently placed around the neck of a child when they weren't being closely watched by the hospital staff or caregivers.

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


Homepage: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/