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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
The issue has caused at least 60 injuries and 23 fatalities.

This recall is classified by FDA as a class I recall. Cortrak 2 eternal access system Cortrak 2 eternal access system https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/ This is the most serious form of recall. These devices can cause serious injuries, or even death.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Sam Brusco Associates Editor05.16.22

The FDA has discovered the recall by Avanos Medical of its Cortrak*2 enteral access system. 629 devices manufactured between 2016 to 2022 were recalled within the U.S., beginning on the 21st of March.

Cortrak 2 eternal access system Cortrak*2 is a tool that allows doctors to insert medical feeding tubes in patients stomachs or small bowels.

Due to injuries and deaths caused by the system, it was removed. An error in inserting the Nasogastric or Nasoenteric tube could result in severe injury or death.

According to Avanos the number of incidents has been a total of sixty injuries and 23 deaths connected to this problem. The adverse events that were reported included pneumonia, perforation, respiratory failure, pneumonia, in addition to the pleural effusion.

Cortrak*2 will utilize the recall to update its directions for usage and intended usage. It will also instruct users to verify tube placement with the help of institutional protocols prior to providing nutrition.

Clinicians were advised to attach the corrective field notice regarding the issue to their operating manual and return the acknowledgement form which was included with the notification to Avanos. The company is planning to provide users with current labeling as well as confirmation of placement of tubes according to the policies of the institution.

Cortrak 2 eternal access system
Homepage: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/