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This has led to more than 23 deaths and 60 injuries.
This recall was identified by the FDA as a Class I recall. It is the most serious type of recall. Avanos Medical feeding tube https://avanos.medicalgzct087.bravejournal.net/post/2023/05/07/Avanos-Medical-Announces-Recalls-of-the-Cortrak*2-Entry-Access-System Utilizing these devices can cause serious injury or death.
Avanos Medical Cortrak 2 eternal access system Sam Brusco Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of its Cortrak*2 enteral access system. The recall of 629 devices that were distributed between 2016-2022 began on the 21st of March.
Cortrak*2 permits clinicians to insert medical feeding tubes in the stomach or small bowel of patients that require nutritional assistance.
Avanos Medical The device was temporarily recalled because of injuries and death reports resulting from nasocentric and Nasogastric tube misplacement while the device is used to help place these tubes. Incorrectly inserting a nasogastric tube or nasoenteric tube can result in severe injury, or even death.
feeding tube placement As per Avanos safety information the issue has resulted in sixty injuries and 23 deaths. Avanos Medical Many adverse events have been reported which included pneumonia, respiratory failure and pneumothorax.
The recall is used to revise Cortrak*2's guidelines on use and intended use and instructing users to confirm tube placement based on protocol guidelines before making use of the tube to provide nutrients.
Clinicians were required to attach the correction notice about the problem to the operating book and then return acknowledgment forms along with the note to Avanos. The company aims to soon provide users with current labeling, which will include confirmation of tube placement in accordance with the institution's policies prior to usage.
Cortrak 2 eternal access system
Read More: http://controlc.com/5083d4e5
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