Notes

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

Avanos Medical has recalled Cortrak*2 EAS in response to reports of injuries and deaths from tube malfunctions.

Avanos Mediacal Cortrak 2 The US Food and Drug Administration has acknowledged Avanos Medical's Cortrak*2 Enal Access System Recall (EAS) in a Class I recall.

The term "Class I Recall" is a reference to the most difficult of three classes.

Avanos Medical recalls Cortrak*2 EAS after reports of injury and even death caused by incorrect placements of nasogastric or nasal tubes.

Avanos Medical feeding tube The device was developed to aid trained health professionals in putting medical feed tubes into patients.

feeding tube placement A wrong placement of the Nasogastric tube and nasoenteric tube could result in serious injuries or death.

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

According to the recall communication the company said that in the year 2015, there have been 60 injuries and 23 deaths as a result of the incorrect placement or use of Nasogastric feeding tubes while making use of the Cortrak* 2 EAS.

Avanos Medical feeding tube Following the recall, Avanos Medical will update the labeling of the device. This will include updating Cortrak*2 EAS's instructions and expected uses.

The revised guidelines require users to confirm the position of tubes according to protocols of their institutions before making use of the tubes.

Avanos Medical has its headquarters in Alpharetta Georgia. Its brands are sold in over 90 countries.

The company signed an agreement to purchase OrthogenRx for $160 million in December. Avanos Medical successfully closed the acquisition of OrthogenRx on the 20th of January.


Read More: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015