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AVANOS MEDICAL FACES CLASS I RECALLS FOR ITS THE FEEDING TUBE SYSTEM THAT HAS
BEEN CONNECTED TO 23 DEATHS IN 2015

Author: Avanos
Posted On: December 4, 2022, 1:10 pm

After seven years of failure for Avanos Medical’s Enteral Feeding Tube Placement
Systems The FDA has given the most severe category for recalls.

Cortrak*2 Enteral Access System features an electromagnetic stylet with an
external receiver, a display monitor and an electronic receiver. The system
provides a live feed of medical feeding tubes that are inserted into patients'
stomachs or small bowels. This permits an improvement in tip placement accuracy
as well as the elimination of any complications.

Despite this mission, the system has been linked to a number of patient
injuries, leading Avanos to issue a recall earlier this year of all Cortrak*2
devices used between January 2021 and January 2022--totaling around 630 devices
initially released between April 2016 and the beginning of the year.

Avanos Medical The safety event doesn't constitute an recall in the strictest
sense. Avanos isn't asking healthcare providers to have the device returned to
the manufacturer. It's simply to make sure that they're using the device in a
safe manner.

A feeding tube installed incorrectly could cause injuries to vocal cords or the
tracheas. According to FDA, Avanos received reports of 23 deaths and 60
injuries, since 2015, all linked to FDA's use of the Cortrak*2 system to guide
the placement of the feeding tube.

These injuries could include respiratory insufficiency, collapsed lungs, lung
infection, as well as holes within the walls of the lungs and esophagus.



Avanos Medical feeding tube Avanos Medical feeding tube Avanos Medical feeding
tube According to FDA, in the March 21 Field Correction Notice the Georgia-based
company asked users to "confirm the placement of Nasogastric (and nasoenteric)
tubes in accordance with institutional policy." Avanos Medical feeding tube
Avanos has requested that users add a safety warning to their operating manuals
and verify they have received the updated.

Avanos announced that they will soon issue an updated labeling for the device.
It will include the directions to put tubes according to their guidelines.



This is the FDA’s second caution in relation to enteral-feeding tubes. In
February, the FDA put out a safety announcement informing healthcare
professionals and parents of the risk of strangulation when children are using
feeding tubes.

https://recalls-rappels.canada.ca/en/alert-recall/cortrak2-enteral-access-system-eas https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
Following two deaths in 2021 a notice was issued. In both instances, a tubing
device was found to have been inadvertently wrapped around neck of patient under
2 years old, while they were not being watched by caregivers or hospital
workers.

"While the FDA believes that strangulation by enteral feeding tube tubing in
children is not common," the agency noted in the notice. It suggested that other
similar cases might not have been reported yet to the FDA.


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Tags: Avanos Medical


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