FDA identifies Avanos Medical's Cortrak*2 EAS recall as Class I

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26 May 2022

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Avanos Medical pulled Cortrak*2 EAS from service after receiving reports about injuries and deaths related to tube missing.

The US Food and Drug Administration has classified Avanos Medical's Cortrak*2 enteral Access System (EAS), as a Class 1 recall.

A Class I recall is a reference to the most severe of three classes.

https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ Avanos Mediacal Cortrak 2 https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 Avanos Medical recalls Cortrak*2 EAS after reports of injuries and even death caused by misplacements of nasogastric or nasoenteric tubes.

The device is able to aid trained health care professionals in placing medical feeding tubes into patients. feeding tube placement https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement It also provides in real-time information regarding tube placement.

But, incorrect placement of nasogastric/nasoenteric tubs can cause severe injuries, or even death.

Avanos Mediacal Cortrak 2 The recall covers 629 devices sold in the US between 1 February 2016 until 1 January 2022.

The recall notification from the company said that 60 patients suffered injuries and 23 died due to the wrong placement of nasogastric tubes when making use of Cortrak* 2 EAS.

Avanos Medical will make the necessary changes to the labelling of the device following the recall. This includes updating the directions for use , as well as intended uses of Cortrak*2 EAS.

These updated guidelines require users to check the placement of tubes as per the guidelines of the institution's prior to using the tube.

Based in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. The company's products are distributed in more than 90 countries.

The company entered into a $160m agreement last December to acquire OrthogenRx. Avanos Medical closed on the acquisition in January.

My Website: https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical

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