Notes

Avanos has been recalled by FDA Class I after 23 Deaths Related to Device
Avanos Medical Cortrak*2 Access System was designed to allow trained health professionals to place medical feeding tubes inside the stomachs or small bowels of patients that require nutritional assistance. Since 2015, however, 23 patients have died due to complications related to feeding tube.

Avanos Medical Avanos Medical https://bbs.pku.edu.cn/v2/jump-to.php?url=https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its https://dohabb.com/index.php?page=user&action=pub_profile&id=2987460 There have been numerous instances of patient injuries and deaths resulting from misalignment or misplacement of nasogastric, also known as nasal, or nasoenteric tube. These devices are utilized to assist in the placement of their tubes.

This recall is being utilized to create updates to the device's labeling, including the instructions for use as well as the intended use. https://www.pcb.its.dot.gov/PageRedirect.aspx?redirectedurl=https://24x7mag.com/standards/fda-updates/avanos-medicals-enteral-access-system-gets-fda-class-i-recall/ The new instructions advise users to confirm tube placement based on their institution's protocols before using the tube to provide nutrition.

Avanos Mediacal Cortrak 2 Patients can suffer severe injury or even death as a result of incorrectly inserted Nasogastric tubes and nasoenteric ones.

Avanos Medical has issued a recall notification stating that, since 2015, there have been 60 patient deaths and 23 injuries resulting from misplacement nasogastric feeding tube. The adverse events that were reported include respiratory failure and pneumothorax (collapsed lung) and perforation (a hole in the wall of the lung, esophagus or bowel) and pneumonia (a lung infection) and an effusion of the pleura (excess fluid in the space between the lungs and the chest cavity).

Avanos Medical sent a field correction notice on March 21st 2022 to customers who had used the devices between January 2021 and January 2022. The following instructions were contained in the notice:

Verify the location of Nasogastric tubes and the nasoenteric tube in accordance with the institution's policies.
Attach the corrective note in the field to the operator's handbook.
Return the acknowledgement form included along with the email notice to Avanos Medical
Read More: http://sc.sie.gov.hk/TuniS/www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its