Notes

Cortrak 2 EAS from Avanos Medical Raises Patient Safety Issues
Cortrak Medsystems Cortrak 2 device.

11 patients of the MDRs 51 were killed in the mishandling of Cortrak 2 devices.

Fox News just recently reported that Avanos Health had released a Field Correction Notice for Cortrak2EAS due to potential deadly consequences.

This case illustrates the serious dangers of this industry and the impact it has on health.

This revelation could lead to an investigation by the Food and Drug Administration (FDA).

Avanos Medical was not the first to make a mistake with the FDA.
Because of the impact they have on human health, medical devices are one of the most closely controlled sectors around the globe.

Avanos Medical feeding tube In spite of all the rules, there are still some troubling cases within the business.

feeding tube placement While the name "Avanos" may not sound appealing, if you're interested is in the medical device industry you may have come across an instance of this company.

Avanos sold hundreds and thousands of MicroCool surgical dresses from November 2014 to January 2015.

According to the company, MicroCool surgical garments were able to protect against virus and fluid penetration , as they met the highest standards of the FDA. However, the assertion was not true since the gowns failed tests for viral penetration. The company was also changing the sealing methods.

All of these were discovered in July 2016 when the FDA investigated Avanos' surgical gown business.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 The company's documents were falsified made by an employee of the company to deceive the FDA.

The devices were poorly constructed and manufactured in a way that was defective and resulted in accidents to hundreds of people.

Avanos should have been aware they were not the best MicroCool gowns they designed for use in surgery did not offer maximum protection against virus and fluid penetration. What is the reason they say this?

Rememberthat the medical profession is delicate and no one knows how many people died due to their actions.

For more information about Avanos Medical, please call
In July 2021, Avanos Medical agreed to pay $22 million as a part of an Data Processing Agreement (DPA) to resolve this felony count.

Avanos signed a Deferred Prosecution agreement with the Department of Justice in relation to criminal violations of the Federal Food, Drug & Cosmetic Act.

Avanos continues to face issues with their products.

They were repeatedly cited multiple times by FDA and the DOJ for criminal acts in connection with the products. Despite all these efforts, people continue to be unhappy with the products of the company.

Patients should feel safe when making use of medical devices. They needn't worry whether the medical device or their disease will cause death.

If they are not exposed medical device manufacturers like Avanos pose a threat to the safety of patients.

Avanos Medical In multiple cases the company has displayed criminal behavior and should be held accountable.

Avnos Medical Issues: A field correction notice regarding the Cortrak 2 EAS

Avanos Medical is responsible for the production of Cortrak 2's feeding tube.

Similar to surgical gowns and feeding tube placement devices such as the Cortrak 2 can save lives.

Avanos Medical is suing to make a mistake with the MicroCool surgical dressing. This has led to concerns about all medical products manufactured by Avanos Medical.

The fears were valid.

Avanos offered a free field correction to Cortrak 2 EAS. Unfortunately, this may have resulted in injury, or death.

Incredibly, Avanos Medical claims that its system eliminates such issues through visualizing the screen and storing location information when placing the tube. It doesn't require confirmation by x-ray.

Avanos confirmed with Fox News they are in an "ongoing dialogue" with the FDA about the issue.

Avanos Medical They claimed that they were "unable to make a statement" and stated that the FDA did not ask for recall.

It is important to exercise extreme caution in the use of medical devices, like Cortrak 2. Cortrak 2 which have raised concern.

It's been demonstrated that Cortrak2 could severely injure and even risk the lives of patients.

Avanos Medical claims they have improved their manufacturing and medical device approval processes, but the public and health professionals do not know the level of safety these products are.

Avanos Medical offices should be visited by the FDA and the Department of Justice in order to reassure patients and their families.
Homepage: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015