Notes

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

11 MDRs out of 51 were killed because of misuse of the Cortrak 2 unit.

Fox News just recently reported that Avanos Health had published a Field Correction Notice for Cortrak2EAS due to the possibility of deadly results.

This is an unmistakable reminder of the risks of the business that fuels the tube and its effect on the lives of the people.

This could lead to an investigation being conducted by the Food and Drug Administration (FDA).

Not the first time messing with the FDA - Avanos Medical had a Criminal Charge against it for Fraudulent Misbranding
The medical device industry is among the industries that are most controlled globally due to its effect on the lives of humans.

Despite these regulations, there are still several cases that are alarming in this industry.

While the name "Avanos medical" might not seem immediately obvious, it's possible that you've been watching the news about medical devices to find out about a particular case about this company.

Avanos sold hundreds upon thousands of MicroCool surgical clothing , misbranded between November 2014 & January 2015.

According to them according to them, they claimed that the MicroCool surgical gowns met the highest standard that was set by the FDA and were able to effectively guard against virus and fluid penetration. But, this assertion was not true as the gowns for surgery failed tests of penetration by viruses and the company was modifying the methods used to seal these gowns.

They were all discovered after FDA investigators looked into Avanos's business using surgical gowns.

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

These devices that were defective caused injuries to hundreds.

In other words, if Avanos realized they were not able to prove that their MicroCool surgical gowns didn't offer the highest safety against fluid and virus penetration, why did they make this claim, and then fake documents?

Be aware that medical professionals are delicate and many lives have been lost because of their actions.

Avanos Medical is available for consultation
Avanos Medical made a $22 million payment as part of a Data Processing Agreement.

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

Avanos is currently experiencing problems in its products.

The FDA and DOJ have issued citations to them numerous times for criminal activities related to their products. Despite all the efforts, many people still have problems with the products of the company.

Patients need to feel safe when using medical devices. In order to not worry about what might kill them, their medical device, or even their illness.

Avanos and other medical device companies could pose a risk to the safety of patients if they are not made aware.

The criminal conduct of the company has been proven in numerous instances. The company should be held accountable.

Avnos Medical issue a correction notice about Cortrak 2 EAS

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

Avanos Mediacal Cortrak 2 As with dressing gowns for surgery and devices to place feeding tubes, such as the Cortrak 2, are vital in saving lives.

There is concern over all medical devices produced by Avanos Medical because of the confusion of the brand name for MicroCool surgical gowns.

Avanos Mediacal Cortrak 2 The concerns raised were valid.

Cortrak 2 eternal access system Avanos released an uninvoluntary correction to Cortrak 2 EAS. This could have resulted in injuries or even death.

It's ironic that Avanos Medical claims it avoids this issue by using screen visualizations and location information during tube placement. They can confirm the tube's placement using x-rays less often.

Fox News interviewed Avanos to confirm that they are engaged in an ongoing dialog with FDA regarding this matter.

They claimed they "cannot speak" and said that the FDA hasn't asked the FDA to initiate a recall on a particular product.

It is crucial to exercise extreme caution in the use of medical devices such as the Cortrak 2 which have raised concern.

It has been proven that Cortrak 2 can seriously cause injury or even risk the lives of patients.

Avanos Medical feeding tube Avanos Medical claims that they have made improvements to the production of medical devices approval systems. However, it is difficult for health professionals to be sure about how safe these products actually are.

The FDA and the Department of Justice should pay another visit to the Avanos Medical offices to reassure the patients and their families.
Read More: https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/