Notes

Cortrak EAS 2 from Avanos Medical Causes Questions About Patient Safety
Cortrak Medsystems Cortrak 2 device.

One of the 51 MDRs passed away from misusing the Cortrak 2 device.

Fox News recently revealed that Avanos medical issued an error correction field note for its Cortrak2 EAS. feeding tube placement This was due to the possibility of fatal results.

This case illustrates the serious dangers of this business and its impact on the health of people.

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

It's not the first time that they've had to mess with the FDA - Avanos Medical had a Criminal Indictment against it for Fraudulent Misbranding
Due to its effects on human life medical devices are among of the most closely controlled industries in the world.

There are, however, troubling cases in the industry despite these rules.

Avanos Medical feeding tube While the title "Avanos medical" may not immediately obvious, it's likely that you've been following the news regarding the medical device industry to find out about a particular case regarding this company.

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 FDA's highest standards for protection against the penetration of viruses and fluids. However, the claim was a lie since the gowns failed the tests to determine if they penetrated virally. The company was also changing the sealing methods.

All this was revealed in July 2016 when the FDA was investigating Avanos"surgeon's business.

To to deceive FDA to deceive FDA, they discovered falsified documents issued by the company.

The defective devices could have caused injury to hundreds.

So if Avanos knew that their MicroCool surgical gowns didn't offer the greatest protection against virus and fluid penetration Why did they make the claim? And did they lie on documents?

Be aware that the medical field is extremely delicate. Who can tell how many patients died due to their conduct?

Avanos Medical can be reached for more information
Avanos Medical paid $22 million in July 2021 under an Data Processing Agreement. This was done to settle the charge of 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.

feeding tube placement Avanos continues to have problems with their products.

Multiple times, they were identified by FDA and DOJ for criminal acts connected to issues with their goods. https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical Despite all the efforts of the agencies, there are people still having problems with their products.

Patients should feel comfortable using medical devices. They don't need to worry about what might end their life first - the medical device or their sickness?

Avanos as well as other medical device makers, pose a threat for patients' safety.

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

Avnos Medical Issues is a field correction notice regarding the Cortrak 2 EAS

Avanos medical manufactures the Cortrak2 feeding tube.

Similar to surgical gowns, but with feeding tubes, devices such as the Cortrak 2 that place feeding tubes are vital to saving lives.

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

The concerns were valid.

Avanos provided a voluntary field correction to Cortrak 2 EAS. Unfortunately it could have led to injury, or even death.

The irony is that Avanos Medical claims that their method eliminates these issues by using location information as well as screen visualization during a tube positioning. This allows them to avoid the need for xray confirmation.

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

They stated that they "cannot speak" on the matter and further stated that the FDA hasn't yet requested recalls of the products.

If you are using medical devices, such as Cortrak 2, Cortrak 2, which have already raised cause for concern, there is a need for extreme caution.

It's been proven that Cortrak2 could severely injure and even risk patients' lives.

Despite the improvements that Avanos Medical claims to make to their production and medical device approval systems medical professionals and patients aren't able to know for sure the safety of these products.

The offices of Avanos Medical should be visited again by both the FDA and Department of Justice. This will assist in reassuring patients and their families. feeding tube placement
Homepage: https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement