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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
There were 60 injuries as well as 23 deaths related to this issue.

The recall has been classed by FDA as a class I recall. This is the most serious form of recall. The devices could cause serious injuries and even death.

feeding tube placement Avanos Medical feeding tube Sam Brusco, Associate Editor05.16.22

The FDA has confirmed Avanos Medical's recall of its Cortrak*2 intramuscular access device. 629 devices, distributed between 2016 and 2022, were recalls by the U.S. starting on March 21.

feeding tube placement Cortrak*2 is a device that lets doctors introduce medical feeding tubes into patients' stomachs or small bowels.

This recall was initiated in response to reports of injuries and even death among patients after misplacement of nasocentric or gastric tubes. Avanos Mediacal Cortrak 2 The device is used to position these tubes. If a nasogastric, or nasoenteric tube is inserted incorrectly, damage can occur to the vocal cords, lungs or trachea, which can result in grave injury or even death.

According to Avanos' safety communications, there were 60 injuries and 23 fatalities related to this incident. Numerous adverse events have been reported, including pneumonia, respiratory failure and pneumothorax.

Cortrak*2 has utilized the recall to make updates to its guidelines for its use. The new instructions contain instructions for users to verify that tubes are set up according to institutional protocols prior to using them to deliver nutrition.

Clinicians were also advised to attach the amended field notice on the issue to Avanos operating manual and to return the acknowledgement forms included in Avanos' announcement. The company is expected to be able to provide updated labeling for users, which will include confirmation of the tube's placement according to the policies of the institution.

https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/
Here's my website: https://www.cyberera.com.ng/2022/05/17/avanos-medical-faces-class-i-recall-for-feeding-tube-system-linked-to-23-deaths-since-2015/
     
 
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