Notes

Cortrak 2 EAS by Avanos Medical Boosts Patient Safety
Cortrak Medsystems Cortrak 2 device.

Avanos Medical feeding tube One of the 51 MDRs died due to misuse of the Cortrak 2 device.

Fox News recently revealed that Avanos medical issued an error correction field note regarding its Cortrak2 EAS. This was due to potentially deadly outcomes.

This is a stark reminder of the dangers of the industry that feeds the tube and its impact on the lives of individuals.

The Food and Drug Administration might be conducting an investigation into the incident.

Not the first time messing with the FDA - Avanos Medical had a Criminal charge brought against it for fraud. Misbranding
Because of the impact they have on human lives medical devices are among of the most tightly controlled sectors around the globe.

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

Cortrak 2 eternal access system While the title "Avanos Medical" might not sound familiar but if you're an avid follower of medical device industry news you might have read about a controversy that involved the company.

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

According to the company's claims, MicroCool surgical garments were able to protect against virus and fluid penetration by meeting the highest standards of the FDA. However, this is not true since the gowns passed the tests for virus penetration. Furthermore the company was altering the method of sealing the gowns.

All of this was discovered in the course of FDA examined Avanos"surgeon's business.

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

These devices that were defective caused injuries to hundreds.

Avanos Medical So if Avanos was aware that their MicroCool surgical gowns didn't offer the highest safety against virus and fluid penetration, why did they make the claim? And did they falsify documents?

Keep in mind that the medical field is a delicate field. Who knows how many lives were affected by their work.

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

Avanos as well as the Department of Justice reached a agreement on deferred prosecution in relation to violations that are criminally committing Federal Food, Drug & Cosmetic Acts (FDCA).

Avanos has had numerous problems with its products up to the present.

Numerous times, they've been cited by the FDA and the DOJ for criminal activities in connection with issues with their goods. Despite the efforts of the agencies, many people are still having problems with the company’s products.

Patients must feel secure using medical devices. Patients needn't worry about the medical device that will cause death first.

If not exposed medical device manufacturers like Avanos can pose a threat to the health of patients.

This company has shown criminal behavior in multiple instances. It has to be accountable for its actions.

Avnos Health Issues is a field correction notice concerning the Cortrak 2 EAS

Avanos medical, as stated, is responsible for the production of the Cortrak 2 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 dressing. Cortrak 2 eternal access system This has raised concerns regarding all medical products made by Avanos Medical.

In fact, these issues were legitimate.

Avanos has, as previously reported, released a voluntary correction field to the Cortrak 2 EAS. That could have resulted in the death of a person, injury or both.

Ironically, Avanos Medical claims their system helps to prevent this from happening by using screen-based visualization and location information for the placement of the tube. They can do this without the need to obtain x-ray confirmation.

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

They stated that they "cannot make any comments" and added that the FDA hasn't asked the FDA to conduct a product recall.

It is important to exercise caution when using medical devices such as Cortrak 2, as these devices have raised concerns.

It has been demonstrated that Cortrak 2 can seriously injure or even endanger patients' lives.

https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Avanos Medical claims they have made substantial improvements to their manufacturing and approval process, however, patients and health professionals are not able to know how safe these products truly are.

Avanos Medical should be visited time and time again by the FDA and Department of Justice to provide peace to patients and their families.
Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement