Notes

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

Among the 51 MDRs 11, 11 patients died as a result of misuses of the Cortrak 2 device.

Just recently, Fox News revealed that Avanos Medical has issued an advisory for field corrections regarding its Cortrak 2 EAS due to the possibility of fatal results.

feeding tube placement This case highlights the grave dangers of this industry and its impact on the health of people.

Cortrak 2 eternal access system The news could trigger the Food and Drug Administration (FDA) investigation.

Avanos Medical was not the only one to play with the FDA. A criminal case was filed against the company for fraudulent misbranding.
feeding tube placement The impact of medical devices human lives makes it one of the most highly monitored industries around the world.

Despite the stringent regulations there are still a few troubling cases.

Although it might not sound like a huge deal, the name Avanos Med could be a big deal. If the story is connected to the medical device industry it is possible that you have read about an interesting incident.

Avanos has sold thousands of MicroCool sacrificial gowns between November 2014-January 2015.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause They stated that MicroCool surgical gowns met FDA's standards for the highest quality and could block the spread of viruses and fluids. But, this claim was not true because the surgical gowns failed the tests to determine if they penetrated virally. The company was also changing the sealing methods.

https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/ All of them were discovered by FDA inspectors in July 2016 when they conducted an investigation into Avanossurgical gowns' business.

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

The devices were poorly constructed and defectively created, resulting in the deaths of hundreds of people.

Avanos should have been aware they were not the best MicroCool gowns they designed for surgical purposes did not offer maximum protection against fluid and virus penetration. So why did they say this?

Medical professionals are delicate and numerous lives were lost as a result of their actions.

For more information on Avanos Medical, please call
Avanos Medical made a $22 million payment as a part of a Data Processing Agreement.

Avanos and the Department of Justice reached a deferred prosecution arrangement regarding violations that are criminally committing Federal Food, Drug & Cosmetic Acts (FDCA).

Avanos's products have been causing problems for many years.

Many times, they've been penalized by the FDA and the DOJ for criminal activity in connection with issues with their products. Despite all the efforts of the agencies, many people are still having problems with the products of the company.

Patients should be comfortable when using medical equipment. So they don’t have to worry about who is going to kill their first, the medical device or their illness.

Avanos as well as other manufacturers of medical devices, pose a threat for the safety of patients.

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

Avnos Medical issue a corrections notice regarding Cortrak 2 EAS

Avanos medical manufactures the Cortrak2 feeding tube.

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

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

The concerns were valid.

As we mentioned earlier, Avanos released a voluntary field correction for the crucial Cortrak 2 EAS, that could have caused injuries or even death.

It's ironic that Avanos Medical claims its system will prevent such issues through screen visualization and location information when placing the tube. This way, they require less confirmation by x-ray.

Fox News reported that Avanos confirmed in a conversation with Fox News that they are currently in an "ongoing discussion" with FDA concerning the matter.

They claimed that they were "unable to make a statement" and stated that the FDA did not request recall.

In the case of medical devices such as the Cortrak 2, which have already raised concerns it is imperative for extreme caution.

It has been shown that Cortrak2 can cause serious injuries and even death to patients.

Avanos Medical may have made some improvements in the production process and approval of medical devices, but it's not possible to guarantee the safety of patients and other health professionals.

The FDA and the Department of Justice should pay another visit to the offices of Avanos Medical to provide comfort to patients and their families.
Here's my website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015