Notes

Cortrak EAS 2 of Avanos Medical Raises Concerns About Patient Safety
Cortrak 2 is operated by Avanos Medical -- can patients feel safe with Cortrak? https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical New Report could reveal the solution

Avanos Medical was one of the pioneers of the manufacture of Cortrak 2 Enteral Access System.

The Cortrak 2 device is a feeding tube placement device used in the medical field.

Between January 2012 to July 2017, the FDA received 51 Medical Device Reports (MDRs) about pneumothorax events related to the Cortrak Medsystems Cortrak 2 device.

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

Fox News has just revealed that Avanos Med published a field correct notice for Cortrak2 EAS. This was to protect against potentially deadly outcomes.

This shows the grave risks of feeding tubes and their effects on human lives.

The information could lead to the Food and Drug Administration (FDA) investigation.

Avanos Medical was not the only one to mess with the FDA. A criminal case was filed against the firm for fraud in false branding.
Cortrak 2 eternal access system The medical device industry is among the most regulated sectors globally because of the impact it has on human lives.

In spite of these rules yet, there are many worrying cases in this industry.

Although it might not sound like an issue, the title Avanos Med might. However, if the story is connected to the medical device industry it is possible that you have read about an interesting instance.

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

According to MicroCool's website, the surgical gowns meet the FDA's highest standards for protection against viruses and fluids. The company had to change the sealing techniques and failed the viral penetration test This claim is not true.

Avanos Medical All these came to light in July of 2016 when the FDA was investigating Avanos"surgeon's gown business.

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

These poorly-designed devices resulted in the injury of hundreds.

If Avanos knew that their MicroCool surgical gowns weren't protected from virus and fluid penetration, then what is the reason they claimed safety and falsify documentation?

Remember, the medical profession is a delicate one and it is hard to know how many people died because of their actions.

Avanos Medical feeding tube For more information on Avanos Medical, please call
Avanos Medical arranged to pay $22 million under a Data Processing Agreement.

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

Avanos continues to have problems with their products.

They have been cited multiple times by the FDA as well as the DOJ for criminal activities associated with issues with their goods. Despite the best efforts made by agencies there are still some who have problems with the company's products.

Patients should be comfortable when using medical equipment. They needn't worry whether their medical device or their disease will cause death.

Avanos as well as other medical device companies pose a threat to the safety of patients if they are not exposed.

The company's criminal behavior has been proven in numerous instances. Avanos Medical The company has to be held accountable.

Avnos Medical issues a correction notice about Cortrak 2 EAS

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

Similar to surgical gowns, feeding tube placing devices such as Cortrak 2 Cortrak 2 can save lives.

The issue of the misbranding of the MicroCool surgical gowns manufactured by Avanos Medical has raised cause for concern about all medical devices manufactured by the company.

These concerns were indeed correct.

As stated before, Avanos released a voluntary field correction for the vital Cortrak 2 EAS, that could have resulted in injuries or even death.

It's ironic that Avanos Medical claims that their system avoids such issues through the use of location information and the screen's visualization during tube's installation. https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015 They are able to verify their tube placement with x-rays less often.

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

They stated that they "cannot make any comments" on the subject and also stated that the FDA hasn't asked for a recall of products.

Great caution is required when using medical gadgets like Cortrak 2, as these devices have caused concern.

It has been proved that Cortrak2 can seriously injure or even threaten patient's lives.

Avanos Medical may have made some changes to the product's production and medical device approval process However, it's not enough to guarantee the safety of patients and other health professionals.

Avanos Medical offices should be visited by the FDA along with the Department of Justice in order to provide comfort for the families of patients.
Homepage: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015