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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This has led to the deaths of 23 people and 60 injuries.

Avanos Medical Cortrak 2 eternal access system Avanos Medical Avanos Medical feeding tube The FDA has declared this a Class I Recall, which is the most serious type. These devices could cause serious injuries and even death.

Sam Brusco, Associate Editor05.16.22

The FDA has identified Avanos Medical's recall of its Cortrak*2 access device for use in the system. 629 devices manufactured between 2016 until 2022 were recalls within the U.S., beginning on the 21st of March.

Cortrak*2 is a tool that permits doctors to place medical feeding tubes inside patients stomachs or small bowels.

The recall of the system was due to patient deaths and injury following misplacement of nasocentric/nasogastric tubes. These tubes are used to aid in placing them. feeding tube placement A nasogastric, or nasoenteric, tube which is not properly placed could cause injury to the vocal cords or trachea. This could lead to severe injury or death.

According to Avanos' safety communication, there have been 60 injuries and 23 deaths related to this issue. Adverse events reported included pneumothorax, respiratory failure, perforation, pneumonia and the pleural effusion.

Avanos Mediacal Cortrak 2 The recall is being leveraged to update Cortrak*2's instructions on use and intended use, instructing users to confirm tube placement based on guidelines for institutions prior to making use of the tube to provide nutrition.

Avanos Medical Clinicians were also asked to attach the correction notice concerning the issue in the operating book and then return the acknowledgement form with the notification to Avanos. Avanos plans to give users an updated labeling, including confirmation of the placement of tubes as per the policies of the institution prior to use.


Here's my website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015