Notes

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

11 MDRs of the 51 who died because of misuse of the Cortrak 2 unit.

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

This is a stark warning of the risks of feeding tubes and their impact on human life.

This could lead to an investigation by Food and Drug Administration.

Cortrak 2 eternal access system Avanos Medical was not the only company to tamper with the FDA. A criminal case was brought against the company for fraud in branding.
Because of its effect on human life The medical device industry is one of the most rigorously regulated industries in the world.

In spite of these rules however, there are many worrying cases in this sector.

Cortrak 2 eternal access system Although it might not sound like a huge deal but the title Avanos Med might. However, if the news is related to the medical device industry it is possible that you have read about an intriguing case.

From November 2014 until January 2015, Avanos sold hundreds of thousands of counterfeit MicroCool surgical gowns.

According to them according to them, the MicroCool surgical gowns met the standards that was set by the FDA and could effectively protect against the penetration of viruses and fluids. But, this claim was not true since the gowns failed tests for viral penetration. The company was also changing the sealant techniques.

All this was revealed in July 2016 when the FDA investigated Avanos"surgeon's gown business.

The FDA was deceived by false company documents , which were drafted by an employee of the company.

These devices were poorly designed and poorly constructed and resulted in accidents to hundreds of people.

Cortrak 2 eternal access system If Avanos were aware that their MicroCool surgical gowns weren't protected from virus and fluid penetration, then why did they claim such safety and falsify documentation?

Remember that the medical profession is delicate. It is impossible to know how many lives were affected by their actions.

Call for further scrutiny into Avanos Medical
Avanos Medical made a $22 million payment as part of a Data Processing Agreement.

Avanos has signed a voluntary agreement with the Department of Justice to defer prosecution for criminal violations of Federal Food, Drug & Cosmetic Act.

Avanos' products have caused problems for many years.

They have been penalized repeatedly by the FDA as well as the DOJ for criminal acts associated with issues with their goods. Despite all these agency efforts, there are some who still experience problems with the products of the company.

Patients must feel comfortable when using medical devices. Patients don't have to be concerned about which medical device will kill them first.

Avanos and other medical devices companies pose a threat to the safety of patients if they are not exposed.

Cortrak 2 eternal access system The company is accused of committing crimes in numerous cases. They are required to be held accountable.

Avnos Medical issue a correction notice about Cortrak 2 EAS

Avanos Medical is the manufacturer of Cortrak 2's feeding tube.

The Cortrak 2 feeding tube placement device, which is like surgical gowns in saving lives, is also vital.

Avanos Medical feeding tube Avanos Medical misbranded the MicroCool surgical dressings, which has raised concerns about all medical devices manufactured under the control of the company.

These concerns were indeed correct.

Avanos made a voluntary field correction to the Cortrak 2 EAS. It could have led to an injury or even the death of.

It's ironic that Avanos Medical claims its system can avoid such problems by using screens that display location information and screen images when placing the tube. They can do this without having to have x-ray verification.

Fox News' Avanos confirmed to Fox News that they are in an "ongoing dialogue" with FDA regarding the matter.

They claimed that they had no comment to make and added that the FDA has not requested to recall any products.

It is important to exercise extreme precautions when using medical equipment , such like Cortrak 2, that have already raised concerns.

It has been demonstrated that Cortrak 2 can severely injure and cause the end of the lives of patients.

Despite the changes that Avanos Medical claims to make to their production and approval processes for medical devices medical professionals and patients can never be sure the safety of these products.

The FDA and the Department of Justice should pay another visit to the Avanos Medical offices to assure the patients and their families.
Homepage: https://www.fdanews.com/articles/203704-avanos-medical-to-pay-22-million-settlement-over-misbranded-surgical-gowns