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

This recall has been identified by the FDA as an Class I recall. Avanos Medical Avanos Medical It is the most serious type of recall. The devices could result in severe injuries or even death.

Sam Brusco is Associate Editor05.16.22

The FDA has identified Avanos Medical's recall for the Cortrak*2 oral access system. 629 devices made between 2016 until 2022 were recalls, with the first recall occurring on March 21.

Cortrak*2 is an instrument that permits doctors to introduce medical feeding tubes into patients stomachs or small bowels.

This recall was prompted in response to reports of injuries and deaths in patients due to the incorrect placement of gastric or nasocentric tubes. https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 The device is used to place the tubes. An error in inserting the Nasogastric or Nasoenteric tube could cause severe injury or even death.

As per Avanos safety information, this issue has caused 60 injuries and 23 deaths. Pneumothorax and pneumothorax (perforation) pneumonia, and pleural effusion have all been listed as adverse events.

https://medicaldevices.icij.org/devices/hkg-cortrak-2-enteral-access-system-eas Cortrak*2 has used this recall to improve the guidelines for usage and intended use. The users will have to confirm the placement of the tubes according to institutional protocols, before they can be used to provide nutrition.

Clinicians were advised to attach the corrective field note concerning the issue to their operating manuals and return the acknowledgment form that was enclosed with the notification to Avanos. Users will soon receive updated labeling and confirmation that the tubes were placed according to institution policies.

Cortrak 2 eternal access system
Here's my website: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015