Notes

Cortrak 2 EAS from Avanos Medical Raizes Security Concerns
Cortrak Medsystems Cortrak 2 device.

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

Fox News just recently reported that Avanos Health had published an update to the Field Correction Notice for its Cortrak2EAS due to the possibility of deadly consequences.

Cortrak 2 eternal access system This case demonstrates the serious risks of this industry as well as its effect on people's health.

This information could trigger an investigation by the Food and Drug Administration (FDA).

It's not the first time that they've had to mess with the FDA - Avanos Medical had a Criminal charge brought against it for fraud. Misbranding
The effect of medical devices human lives makes it among the most regulated industries worldwide.

However, there are worrying cases in the industry despite the regulations.

While the name "Avanos medical" may not immediately apparent, it's possible that you have been following the news regarding medical devices to read about a story regarding this company.

Avanos sold hundreds of thousands of MicroCool surgical clothing that were misbranded between November 2014 and January 2015.

They said that MicroCool surgical gowns meet the FDA's strictest standards and could prevent fluid and virus penetration. This assertion was not true, as the surgical gowns failed to pass the viral penetration tests and the firm was altering how they seal the gowns.

This information was discovered in the month of July by the FDA as it was conducting an investigation into Avanoscompany that sells surgical gowns.

To deceive FDA they discovered false company documents which an employee had prepared.

Avanos Medical Avanos Medical The devices' design flaws caused injuries to hundreds.

So if Avanos was aware they were not able to prove that their MicroCool surgical gowns did not offer the highest safety against the penetration of viruses and fluids Why did they make such a claim and even fake documents?

Remember that medical fields is not without risk and many have suffered fatal injuries as a result of their actions.

Contact Avanos Medical for more information
In July 2021 Avanos Medical agreed to pay $22 million as part of an Data Processing Agreement (DPA) to end this felony.

Avanos has entered into a voluntary agreement with the Department of Justice to defer the prosecution of criminal offenses under the Federal Food, Drug & Cosmetic Act.

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

They were repeatedly penalized several times by FDA and the DOJ for criminal conduct related to the products. Despite the best efforts made by agencies however, there are some who still have issues with the company’s products.

Patients need to feel safe while using medical devices. https://www.rheingoldlaw.com/blog/2022/may/avanos-faces-fda-class-i-recall-after-23-deaths-/ Therefore, they won't have to be concerned about what could end their life first whether it's the medical device, or their sickness?

https://www.dmagazine.com/healthcare-business/2021/07/medical-device-company-to-pay-22-million-for-mislabeling-gowns/ Avanos and other medical device companies can pose danger to the health of patients if they aren't exposed.

The company has been accused of pattern of criminal conduct in several cases and needs to be held accountable for its conduct.

Avnos Health Issues is a correction to the field notification regarding the Cortrak 2 EAS

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

As with dressing gowns for surgery and devices to place feeding tubes, like Cortrak 2, Cortrak 2, are vital in saving lives.

Avanos Medical misbranded the MicroCool surgical dressings, causing concern about all medical devices manufactured by the company's management.

And indeed the concerns were valid.

Avanos offered a free field correction to Cortrak 2 EAS. Unfortunately this could have led in injury, or death.

The irony is that Avanos Medical claims that their method eliminates these issues through the use of location information and the screen's visualization during tube placement. They are able to verify their tube placement with the use of x-rays less frequently.

Fox News confirmed that Avanos and the FDA are engaged in "ongoing dialogue" regarding the matter.

They claimed that they "cannot make any comments" on the subject and also stated that the FDA hasn't requested to recall the products.

It is important to take extreme care in the use of medical devices, like the Cortrak 2 which have raised concern.

It has been demonstrated that Cortrak2 could cause serious injury and even death to patients.

Despite the improvements that Avanos Medical claims to make changes to their manufacturing and approval processes for medical devices, patients and health professionals cannot be certain of that these products are safe.

The FDA and the Department of Justice should pay another visit to the Avanos Medical offices to reassure the patients and their families. Avanos Medical feeding tube
My Website: https://www.medtechdive.com/news/avanos-medical-recall-class-i/623892/