Notes

Cortrak EAS 2 of Avanos Medical Causes Concerns About Patient Safety
Cortrak Medsystems Cortrak 2 device.

11 patients were among 51 MDRs that died as a result of the misuse of Cortrak 2.

Only recently, Fox News revealed that Avanos Medical published a field correction notice for its Cortrak 2 EAS, due to possible dangerous consequences.

This incident shows the dangers of the feed tube business as well as the effects it has on the lives of people.

This could lead to an investigation by Food and Drug Administration.

Avanos Medical was also charged with fraud for branding.
Avanos Mediacal Cortrak 2 Due to the direct impact on human lives, the medical devices industry is among the industries with the highest degree of regulation.

In spite of all the rules there are still alarming cases in the industry.

While the title "Avanos Medical" may not be a familiar one but if you're a follower of the medical device industry you've probably read about a controversy that involved this company.

Avanos sold thousands of MicroCool surgical gowns between November 2014 and January 2015.

According to them they claimed that according to them, the MicroCool surgical gowns met the strictest standards set by the FDA and effectively protected against virus and fluid penetration. The company had to change the sealing methods and failed the viral penetration test therefore this claim was not accurate.

All of this was discovered in the course of FDA conducted an investigation into Avanos"surgeon's business.

The FDA was deceived by falsified company documents that were created by an employee of the company.

These poorly-designed devices led to the injuries of hundreds.

Avanos should have known that MicroCool's surgical gowns weren't the best protection against infection by viruses. However, they claimed they were and falsified documents.

Remember that the medical profession is delicate. It is impossible to know how many lives affected by their actions.

Contact Avanos Medical for more information
Avanos Medical, in July 2021, agreed to pay $22,000,000 as part of an Data Processing Agreement. (DPA). https://www.hcplive.com/view/fda-issues-letter-to-health-care-providers-about-pneumothorax-events The agreement was made to end this felony conviction.

Avanos signed an agreement to defer prosecution with the Department of Justice regarding criminal violations of the Federal Food, Drug & Cosmetic Act (FDCA).

Avanos has had numerous problems with its products up to this point.

Many times, they've been cited by the FDA and the DOJ for criminal activity in connection with issues with their goods. Despite the best efforts of authorities however, there are some who still have problems with the company's products.

Patients need to feel comfortable making use of medical equipment. Patients don't need to worry whether the medical device or their disease will cause death.

Avanos Medical If not properly disclosed medical device manufacturers like Avanos could pose a risk to the safety of patients.

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

Avanos Mediacal Cortrak 2 Avnos Medical Issues A field correction notification regarding the Cortrak 2 EAS

As previously stated, Avanos medical is responsible for manufacturing the Cortrak 2 feeding tube device.

As surgical gowns do, feeding tube placing devices like Cortrak 2 Cortrak 2 can save lives.

Avanos Medical's misbranding of the case of MicroCool surgical dresses has caused worry about all medical equipment made by the company.

The concerns were valid.

Avanos Mediacal Cortrak 2 Avanos has issued an official correction request for Cortrak 2 EAS. This could have led to injury or death.

In a way, Avanos Medical claims their system can prevent these problems by using screen-based visualization and location information for the placement of the tube. This allows them to eliminate the need for confirmation by xray.

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 claimed that they "cannot speak" regarding the issue and also stated that the FDA hasn't asked for a recall of products.

It is important to be careful when using medical devices such as the Cortrak 2, which has been a source of concern for a while.

It has been demonstrated that Cortrak2 can cause severe injury and even death to patients.

Avanos Medical claims they have made substantial improvements to their manufacturing and medical device approval procedures, however, patients and health professionals aren't able to determine how safe these devices are.

Avanos Medical feeding tube Avanos Medical offices should be visited by the FDA along with the Department of Justice in order to reassure patients and their families.
Website: https://www.fdanews.com/articles/207866-avanos-medical-gets-class-i-designation-for-its-recalled-cortrak2-enteral-access-system?v=preview