Notes

Cortrak 2 EAS of Avanos Medical Raises Safety Issues
Cortrak Medsystems Cortrak 2 device.

One of the 51 MDRs died from misusing the Cortrak 2 device.

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

This is an unmistakable reminder of the dangers of the industry that fuels the tube and its effect on the lives of individuals.

This could result in an investigation by Food and Drug Administration.

Avanos Medical was not the first to misbrand the FDA.
Due to the direct impact on human lives due to its direct impact on human lives, the medical device industry is one of the industries that is most tightly controlled.

Despite all the regulations however, there's a lot of concern in the industry.

While it may not seem like an issue, the title Avanos Med could be a big deal. If it is related to the medical device industry, you may have read about an intriguing incident.

Avanos sold thousands of MicroCool surgical clothes and misbranded them between November 2014 & January 2015.

According to them according to them, according to them, the MicroCool surgical gowns met the standards set by the FDA and effectively protected against fluid and virus penetration. However, the assertion was false since the gowns failed tests for viral penetration. The company also changed its sealant techniques.

All of these were discovered by FDA inspectors in July of 2016, as they conducted an investigation of Avanossurgical gowns' business.

They found falsified company documents made by an employee of the company in order to deceive FDA.

Hundreds of people were injured by these dangerous and poorly created devices.

In other words, if Avanos realized they were not able to prove that their MicroCool surgical gowns do not provide the best protection against the penetration of viruses and fluids So why did they put forward this claim, and then falsify documents?

Keep in mind that the medical profession is extremely delicate, and who knows how many lives were lost as a result of their actions.

Request for more scrutiny into Avanos Medical
Avanos Medical arranged to pay $22 Million under a Data Processing Agreement.

Avanos signed a deferred prosecution agreement with the Department of Justice regarding criminal violations of the Federal Food, Drug & Cosmetic Act (FDCA).

At this point, Avanos has repeatedly had problems with its products.

Many times, they were identified by FDA and DOJ for criminal acts connected to issues with their products. Despite all these efforts, consumers continue to have problems with the products manufactured by the company.

Patients should feel comfortable using medical devices. feeding tube placement Therefore, they do not have to worry about who is going to cause their death, whether it's medical device or sickness.

Avanos as well as other medical device makers, pose a threat for the safety of patients.

The company's criminal actions have been exposed in a variety of cases. The company has to be held responsible.

Avanos Medical feeding tube Avnos Health Issues is a field correction notification regarding the Cortrak 2 EAS

Avanos medical manufactures the Cortrak2 feeding tube.

Like surgical gowns, feeding tube placing devices such as the Cortrak 2 can save lives.

Avanos Medical misbranded the MicroCool surgical dressings, which has raised concerns about the quality of all medical devices produced by the company's management.

https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ In fact the concerns were valid.

As we mentioned earlier, Avanos released a voluntary field correction for the vital Cortrak 2 EAS, that could have resulted in injury or even death.

It's ironic that Avanos Medical claims that its solution eliminates these problems through screen visualization and location data when placing the tube. Avanos Medical Avanos Medical feeding tube This allows them to eliminate the need for xray confirmation.

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

They claimed that they were "unable to comment" and claimed that the FDA didn't request a recall.

There is need to be cautious when using medical devices like the Cortrak 2, which has been a source of concern for a while.

https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement It has been proven that Cortrak2 could cause severe injuries and even death to patients.

Avanos Medical claims they have made substantial improvements to their manufacturing and approval processes, but patients and health professionals do not know how safe these devices are.

Avanos Medical offices should be visited by the FDA along with the Department of Justice in order to provide comfort for patients and their families.
Homepage: https://www.techtimes.com/articles/275216/20220509/cortrak-2-eas-from-avanos-medical-raises-patient-safety-concerns.htm