Notes

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

Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and deaths due to tube missing.

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

The most severe of the three kinds is a Class I can remember.

Avanos Medical recalls Cortrak*2 EAS after reports of injuries and even death caused by misplacements of nasogastric or nasoenteric tubes.

The device was designed to aid medical professionals who are trained to place medical tubes for feeding in patients and offer real-time location information on tube placement.

Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 feeding tube placement Incorrect placement of Nasogastric tube and nasoenteric tube could cause serious injury or even the death of a patient.

The company recalls 629 devices sold in the US between January 2016 to January 2022.

Avanos Mediacal Cortrak 2 According to the company's recall communication it was reported that there were 53 deaths and 60 injuries during 2015 because of the incorrect placement of nasogastric feeding tubes during use of the Cortrak* 2 EAS.

Avanos Medical will revise the labelling after the recall. This will include an update of the instructions and the planned uses for Cortrak* 2 EAS.

The revised guidelines require that users confirm the location of tubes based on protocols issued by their institutions before making use of the tubes.

Avanos Medical, based in Alpharetta Georgia in the United States is a producer of clinical medical devices. Avanos Medical sells its products in more than 90 different countries.

The company signed an agreement to purchase OrthogenRx at $160 million during December. Avanos Medical closed on the acquisition in January.

Avanos Medical
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