Notes

Cortrak 2 EAS from Avanos Medical Increases Patient Safety
Cortrak Medsystems Cortrak 2 device.

11 MDRs out of 51 were killed due to misusing the Cortrak 2 unit.

Only recently, Fox News revealed that Avanos Medical published a field correction notice for its Cortrak 2 EAS, due to possible fatal outcomes.

This highlights the serious risks of feeding tubes as well as their impact on human life.

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

Cortrak 2 eternal access system Not the first time we've had a problem with the FDA - Avanos Medical had a Criminal Charge against it for Fraudulent Misbranding
The industry of medical devices is one of the most regulated sectors globally due to its effect on the lives of humans.

In spite of all the rules in place, there's still a lot of concern in the business.

Although the name 'Avanos' might not sound appealing, if your interest is in the medical device industry you may have come across an article about the company.

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

They claimed that the MicroCool surgical gowns would be protected from fluid and virus penetration, and that they met FDA's most stringent standards. However, this was false as the gowns for surgery failed viral penetration tests and the firm was altering the method used to seal these gowns.

These were all discovered when FDA investigators investigated Avanos's business using surgical gowns.

They found falsified company documents done by an employee at the company in order to deceive the FDA.

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

feeding tube placement Avanos probably knew they were not the best MicroCool gowns they designed for use in surgery did not offer maximum protection against infection by viruses and fluid penetration. What is the reason they say this?

Avanos Mediacal Cortrak 2 Remember, the medical profession is delicate and it is hard to know how many people died because of their actions.

Avanos Medical is available for consultation
Avanos Medical arranged to pay $22 million under a Data Processing Agreement.

Avanos signed an agreement for deferred prosecution (DPA) with the Department of Justice for criminal violations of Federal Food, Drug & Cosmetic Act.

Avanos is currently experiencing problems with its products.

The FDA and DOJ have issued citations to them numerous times for crimes related to their goods. Cortrak 2 eternal access system Avanos Mediacal Cortrak 2 Even with the best efforts of agencies however, there are some who still aren't happy with the company's products.

Patients must feel secure using medical devices. Patients don't need to worry whether the medical device they use or their illness could kill them.

Avanos, and other medical device manufacturers could pose a threat to patients' safety.

This company has displayed the worst of behavior in a variety of instances. It must be held accountable for its actions.

Avnos Medical issue a corrections notice regarding Cortrak 2 EAS

Avanos medical produces the Cortrak2 feeding tube.

Like surgical gowns and feeding tube placement devices, such as the Cortrak 2, are vital in saving lives.

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

The concerns were valid.

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

It's ironic that Avanos Medical claims that its system eliminates such issues through the visualization of screens and data on location when placing the tube. So, they'll have less need for the confirmation of x-rays.

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

They told us they could not speak about the matter, and the FDA had not demanded recall of any of their products.

You must exercise caution when using medical equipment such like Cortrak 2, that have already raised questions.

It has been demonstrated that Cortrak2 could cause severe injuries to and even kill patients.

Healthcare professionals and patients cannot be sure about how secure these products really are, despite the claims made by Avanos Medical regarding their production and approval process.

Avanos Medical should be visited once more by the FDA and Department of Justice to provide comfort to patients and their families.
My Website: https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding