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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This issue has led to 60 injuries and 23 deaths.

The FDA has declared this to be a Class I recall, the most severe type of recall. Avanos Medical Use of these devices may cause serious injury or death.

Sam Brusco Associates Editor05.16.22

The FDA has identified Avanos Medical as the person responsible for recalling their Cortrak*2 system of access to the enteral. 629 of the devices produced between 2016 to 2022 were recalled with the first recall happening on March 21.

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

Avanos Medical The system was recalled because of injuries and death reports following nasocentric or Nasogastric tube misplacement while the device is used to help place these tubes. Nasogastric, also known as nasal, tube which is not properly placed could result in damage to the vocal chords and the trachea. This can lead to serious injury, or even death.

According to Avanos safety announcement, this issue has caused 60 injuries and 23 deaths. A variety of adverse events were reported which included respiratory failure, pneumonia, and pneumothorax.

Avanos Medical feeding tube This recall will be utilized to modify Cortrak*2's guidelines for use, intended uses, and instruct users to confirm tube placement as per institutional guidelines prior to making use of the tube to deliver nutrition.

Clinicians were advised to attach the corrective notice for field use concerning the issue to their operating manuals and return the acknowledgment form that was enclosed with the notification to Avanos. feeding tube placement The company plans to give users an current labeling, which will include confirmation of tube placement in accordance with the institution's policies prior to usage.


Read More: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
     
 
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