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AVANOS MEDICAL IS BEING RECALLED DUE TO THE FEEDING TUBE SYSTEM THAT WAS LINKED

Expires in 12 months

15 November 2022

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After seven years' of failure for Avanos Medical’s Enteral Feeding Tube Placing
System Avanos Medical's Enteral Feeding Tube Placement System has failed for FDA
has assigned the most serious classification for a recall.



Avanos Medical feeding tube Cortrak*2 Enteral Access System consists of an
electromagnetic stylet, an external receiver and a display screen. In
combination it provides a live stream of the medical tube as it is placed into
the stomach of the patient.



Avanos was not happy with its mission and launched an immediate recall of all
Cortrak*2 units used between January 2021 and January 2022. Avanos Mediacal
Cortrak 2 The recall covered nearly 630 devices that were distributed between
April 2016 and the start of this year.





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



A feeding tube improperly installed could cause harm to vocal cords, or
tracheas. Cortrak 2 eternal access system Avanos has reported the number of
injuries to patients and deaths to patients in 2015, the FDA declared. All of
them connected to FDA's Cortrak*2 system used to place the feeding tube.





The most common injuries include respiratory failure, collapsed lung, lung
infections, pleural effusion and cracks in the wall of the the esophagus, bowel
and lungs.



According to FDA, in the March 21 Field Correction Notice, the Georgia-based
business advised users to "confirm the use of the nasogastric (and nasal) tubes
according to institutional policy." Avanos is also asking them to attach the
safety statement to the operating manual for the device and verify that they've
received the latest update.



Avanos has announced it will soon release a new labeling system for the device
that will include a direction to map out the location of the tube in line the
policies of their facility prior to making use of the system to assist install
the tube.





The FDA has issued a second warning regarding enteral feeding tubes this year.
Avanos Medical Avanos Mediacal Cortrak 2 The FDA released safety communications
in February, warning parents, healthcare providers, and children about the
dangers of strangulation through tubes feeding food.



Two deaths in 2021 were reported in the announcement. Each of the cases included
a tube that was wrapped around the neck of a baby less than 2 years old, while
the baby was not being watched by staff at the hospital.





"While the FDA believes that strangulation by enteral feeding tube tubing in
children is rare," the agency noted in its notice. It also suggested that
similar incidents may not have been reported yet to the FDA.



Read More:
https://www.justice.gov/opa/pr/avanos-medical-inc-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding-its



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