Notes

Avanos Medical faces a Class I recall of its the feeding tube system that was linked to 23 deaths in 2015.

After seven years of poor results with the Avanos Medical's feeding tube placement system for children The FDA has issued the most severe warning about the recall of this device.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver as well as an LCD monitor. Cortrak 2 eternal access system It can be combined to provide a live feed that shows the process of inserting a medical feeding tube into the stomach of an individual. The procedure is performed with the aim of improving the accuracy of the procedure and decreasing complications.

Avanos launched a recall earlier in the year, affecting all Cortrak*2 units that were used between January 2021 to January 2022. Avanos Mediacal Cortrak 2 This totaled nearly 630 devices. They were distributed for the first time in April 2016 until the beginning of 2016.

RELATED
A tiny device, which promises greater safety, creates chaos for tube feeders
The safety incident is not a recall in its literal sense: Avanos does not ask healthcare providers to return the devices to the manufacturer. Instead, it would like to ensure they are making use of the devices in a safe manner.

Incorrectly inserting the feeding tube can result in damage to vocal cords or lungs. According to FDA, Avanos received reports of 23 deaths and 60 injuries, as of 2015, all related to the FDA's use of the Cortrak*2 system to aid in the installation of a feeding tube.

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

According to FDA the Georgia-based firm reminded users in its March 21 Field Correction Notice to "confirm the use of nasogastric tubes and Nasoenteric tubes in accordance with institution policies". Avanos asked users to include the safety notice in the system's operation manual and confirm with Avanos that the change was received.

Avanos said it will soon release a new labeling system for the device, which will contain the directions to plot a tube's placement in accordance the policies of their facility prior to using the system to help install the tube.

Avanos Mediacal Cortrak 2 Cortrak 2 eternal access system RELATED
FDA is requesting Philips to repair, replace or pay for all recalls of ventilators
This is the second FDA warning this year regarding the use of enteral feeding tubes. In February, the FDA published a safety communication warning parents as well as healthcare professionals about the risk of strangulation as a result of the use of feeding tubes by children.

Following two death reports in 2021, this notice was published. Avanos Mediacal Cortrak 2 The notice was issued following two reports of death in 2021. Avanos Medical In each instance, the tubing system was found to be tied around necks of patients who were under the age of 2.

"The FDA believes that strangulation via tubing for feeding through the enteral system in children is rare, however, healthcare providers and caregivers need to be aware that such instances can occur and can happen," the agency stated in its notice. This indicates that similar incidents could not have been reported to FDA.


Homepage: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/