Notes

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

Avanos Medical called off Cortrak* 2 EAS in response to the patient injury and deaths caused by tube misplacements.

The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak*2 Enteral Access System (EAS) as a Class I recall.

Avanos Medical The most serious of the three types is a Class I can remember.

Avanos Medical Avanos Medical recalled Cortrak* 2 EAS after reports of injuries and patient deaths due to nasoenteric or Nasogastric tube malfunctions.

https://aacnjournals.org/ajcconline/article/29/1/22/30624/Pneumothoraces-Prevented-With-Use-of The device allows skilled healthcare professionals to insert medically-approved feeding tubes into patients.

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

The company has recall 629 units, which were distributed across the US between 1 April 2016 to 1 January 2022.

The recall notification from the company said that 60 patients were injured and 23 died due to incorrect placement in nasogastric tube while using Cortrak* 2 EAS.

Avanos Medical, following the recall, will update the device’s labelling. Cortrak 2 eternal access system This will include updating Cortrak*2 EAS's instructions and intended uses.

These updated guidelines require users to verify tube placement as per the guidelines of the institution's prior use.

Based in Alpharetta, Georgia, US, Avanos Medical focuses on manufacturing clinical medical devices. The brand's name is sold in over 90 countries.

Cortrak 2 eternal access system Last December, the business entered into an agreement to buy OrthogenRx in the amount of $160 million. Avanos Mediacal Cortrak 2 Avanos Medical concluded the acquisition on January 20th.


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