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Avanos is facing an FDA Class I recall after 23 deaths linked to the device
Avanos Medical Cortrak*2 enteral access system is created to permit trained health care professionals to insert medical feed tubes into the stomach or small intestine of patients who require nutrition. There have been 23 deaths related to the feeding tube in the year 2015.

Many reports have revealed that patients suffered trauma or even died when their nasogastric and nasoenteric tubes were misplaced. Cortrak 2 eternal access system It's despite the fact the device was designed to aid in their placement.

This recall is being used to update the device's labeling that include the directions to use. https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges The updated instructions instruct users to confirm tube placement according to the protocols of their institution prior to using the tube to provide nutrients.

Incorrectly inserting a Nasogastric or Nasoenteric tube may result in damage to the vocal chords, lungs or trachea. This could lead to serious injury and even death.

Avanos Medical recalls that there was a total of sixty injuries and 23 deaths from the incorrect placement of nasogastric tubes from 2015. Avanos Medical feeding tube Pneumothorax, respiratory failure, perforation (a hole, or hole in the stomach wall) and pneumonia were all mentioned.

Avanos Medical, on March 21, 2022, sent a field correct notification to its customers who had used the products between January 2021 and January 2022. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding Avanos Medical feeding tube These instructions were included in the notice:

Verify the placement of the nasogastric, nasal and other tubes in line with institutional guidelines.
Attach the correction note from the field explaining the issue to the operator's manual.
Avanos Health Medical asks to return the acknowledgement form with the email notification Avanos Mediacal Cortrak 2
Here's my website: https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges
     
 
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