Notes

Cortrak 2 EAS from Avanos Medical Raises Patients Safety Risks
Cortrak Medsystems Cortrak 2 device.

feeding tube placement One of the 51 MDRs passed away due to the misusing the Cortrak 2 device.

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

This case demonstrates the serious dangers of this business and the impact it has on health.

Avanos Medical feeding tube The Food and Drug Administration might be investigating the revelation.

Not the first time we've had a problem with the FDA - Avanos Medical had a Criminal Indictment against it for Fraudulent Misbranding
Because of its effect on human lives, the medical device industry is among the most tightly monitored industries around the globe.

Despite these regulations yet, there are many worrying cases in this industry.

Although the name "Avanos medical" may not immediately obvious, it's likely that you've been following the news regarding the medical devices industry to read about a story regarding this company.

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

According to them, MicroCool's surgical gowns meet the FDA's most stringent standards of protection against viruses and fluids. However, the assertion was not true since the gowns failed tests for viral penetration. The company was also changing the sealant techniques.

The information was uncovered in the month of July by the FDA when it investigated Avanos’ business selling surgical gowns.

They discovered falsified documents from the company done by an employee at the company to deceive the FDA.

These devices that were poorly designed led to the injuries of hundreds.

Avanos should have known that MicroCool's surgical gowns were not the safest against virus penetration. But they claimed otherwise and forged documents.

Be aware that the medical field is extremely delicate. And who knows how many people were killed due to their conduct?

Avanos Medical feeding tube For more information on Avanos Medical, please call
Avanos Medical, in July 2021, agreed to make a payment of $22,000,000 in the Data Processing Agreement. (DPA). The DPA was signed to close this felony count.

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

At the moment, Avanos has repeatedly had problems with their products.

They were repeatedly cited multiple times by the FDA as well as by the DOJ for criminal conduct connected to their products. Despite all the efforts of the authorities, a lot of people are still experiencing issues with their products.

Patients should feel safe when making use of medical devices. Therefore, they won't have to worry about what might cause them to die first - the medical device or their illness?

If not exposed, medical device companies like Avanos can pose a threat to the safety of patients.

In a number of instances the company has displayed an act of criminality and should be held accountable.

Avnos Medical issues a correction notice about Cortrak 2 EAS

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

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

The case regarding the confusion of the MicroCool surgical gowns manufactured by Avanos Medical has raised cause to be concerned about the medical devices made by the company.

Cortrak 2 eternal access system In fact, these concerns were right.

Avanos performed an error in the field that was made by the Cortrak 2 EAS. It could have led to injury or even death.

In a way, Avanos Medical claims it avoids these problems with screens and visualizations of location information when placing the tube. This lets them avoid the need for confirmation by xray.

Avanos confirmed with Fox News they are in an "ongoing dialogue" with the FDA on the matter.

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

You should exercise great precautions when using medical equipment such like Cortrak 2, that have already raised questions.

Avanos Medical It has been proved that Cortrak2 could severely injure, and even endanger, the lives of patients.

Avanos Medical may have made some changes to the product's production and approval of medical devices however it's still not enough to guarantee safety for patients or other health professionals.

The FDA and the Department of Justice should pay another visit to Avanos Medical's offices to provide comfort to patients and their families.
Homepage: https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/