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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There have been 60 injuries and 23 deaths as a result of this issue.

The FDA has classified this as a Class I recall, the most serious type of recall. The devices could result in grave injuries, and possibly death.

Avanos Medical feeding tube Sam Brusco Associates Editor05.16.22

The FDA has identified Avanos Medical’s recall of its Cortrak*2 intramuscular accessibility system. Beginning on March 21 the 21st of March, 2016, 629 devices were recalled across the U.S.

Cortrak*2 aids clinicians to place medical feed tubes into patients who require nutrition via the tube.

Avanos Medical feeding tube This recall was initiated in response to reports of injuries and death in patients following mistakes in the placement of gastric or nasocentric tubes. The device is used to place these tubes. If a nasogastric tube is incorrectly inserted, damage can occur to the vocal cords, lungs or the trachea, leading to serious injury or death.

According to Avanos' safety communications, there were 60 injuries and 23 fatalities related to this incident. Numerous adverse events were identified which included pneumonia, respiratory failure and pneumothorax.

Cortrak 2 eternal access system Cortrak*2 will make use of the recall process to modify its directions for usage and intended use. It will also instruct users to verify tube placement with the help of institutional protocols prior to providing nutrition.

Clinicians were instructed to add the appropriate field correction notice in the operating manual. They must also return the acknowledgement form included with the Avanos notification. The company hopes to soon give users with an updated labeling. Avanos Medical This will include confirmation that tube placement was done according to institutional guidelines.

https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
Here's my website: https://www.nsmedicaldevices.com/news/avanos-medical-cortrak-2-eas-class-i-recall/
     
 
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