Notes

Cortrak 2 EAS of Avanos Medical Raising Patient Safety Issues
Cortrak Medsystems Cortrak 2 device.

One of the MDRs who died due to misusing the Cortrak 2 device.

Recently, Fox News revealed that Avanos Medical published an error-in-field notice regarding its Cortrak 2 EAS, due to possible deadly results.

This shows the grave dangers of feeding tubes as well as their effects on human lives.

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

Avanos Medical was charged with fraudulent misbranding and it is not the first time they have misbehaved with FDA
The medical device industry is one of the most tightly controlled sectors in the world because of its impact on human lives.

In spite of all the rules and regulations, there are some worrying cases within the business.

The name "Avanos medical" might not ring a bell, but if you read the news about the field of medical devices it is possible that you have heard of a case about this company.

Between November 2014 to January 2015, Avanos sold hundreds of thousands of fake MicroCool surgical gowns.

According to the company's claims, MicroCool surgical garments were capable of defending against viruses and fluid penetration by meeting the FDA's highest standards. But, this assertion was a lie since the surgical gowns failed the viral penetration tests, and the firm was altering the sealing methods used to seal these gowns.

All of these were found by FDA inspectors in July 2016 when they conducted an investigation into Avanosthe surgical gown company.

To deceive FDA They found fake documents issued by the company.

These devices that were poorly designed resulted in the injury of hundreds.

Avanos ought to have realized that MicroCool's surgical gowns weren't the best protection against infection by viruses. They claimed that they were and forged documents.

Be aware that medical professionals are delicate and numerous lives have been lost because of their actions.

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

Avanos as well as the Department of Justice reached a agreement to defer prosecution for criminal violations of Federal Food, Drug & Cosmetic Acts (FDCA).

Avanos Medical Avanos is experiencing issues in its products.

Cortrak 2 eternal access system They have been cited multiple times by both the FDA and DOJ for criminal acts associated with issues with their goods. Even with the best efforts of agencies however, there are some who still have issues with the company’s products.

Patients must feel secure when using medical devices. https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ Patients don't have to be concerned about what medical device is going to kill them first.

Avanos, and other medical device makers are a risk to the safety of patients.

The company is accused of criminal behavior in numerous cases. They must be held accountable.

Avnos Medic Issues A field correction note about the Cortrak 2 EAS

As stated earlier, Avanos medical is responsible for the manufacturing of the Cortrak 2 feeding tube.

Like surgical gowns, feeding tube placement devices such as the Cortrak 2 are essential in helping save lives.

Avanos Medical feeding tube The case regarding the false branding of the MicroCool surgical gowns by Avanos Medical has raised cause for concern about the medical devices made by the company.

In fact the concerns were valid.

Avanos Medical Avanos made a voluntary field correction in Cortrak 2 EAS. Unfortunately this could have led in injury, or death.

The irony is the fact that Avanos Medical claims that their solution is able to avoid such problems by using location information as well as visualizing the screen during tube positioning. It doesn't require confirmation by x-ray.

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

Avanos Mediacal Cortrak 2 They said they "cannot make any comments" and added that the FDA has not requested to conduct a product recall.

It is crucial to take extreme care when using medical devices like the Cortrak 2 which have raised alarm.

It has been demonstrated that Cortrak2 may cause serious injury and even death to patients.

https://www.medscape.com/viewarticle/891200 Avanos Medical claims that they have made improvements to the development of medical device approval systems. However, it's impossible for consumers or medical professionals to know of how safe these devices actually are.

Avanos Medical is a safe location for patients and their loved ones.
Read More: https://zephyrnet.com/sv/fda-identifies-avanos-medicals-cortrak-2-eas-recall-as-class-i/