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This problem has caused 60 injuries and 23 deaths.
Cortrak 2 eternal access system Cortrak 2 eternal access system The FDA has designated this as an Class I Recall, which is the most serious type. These devices can cause serious injuries or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has discovered the recall by Avanos Medical of their Cortrak*2 access system for enteral use. 629 devices, distributed between 2016 - 2022, were recalled by U.S. starting on March 21.
Cortrak 2 eternal access system Cortrak 2 eternal access system Cortrak*2 is an instrument that permits doctors to introduce medical feeding tubes into patients' stomachs or small bowels.
This recall was prompted because of reports of injuries and even death among patients after the incorrect placement of gastric or nasocentric tubes. The device is used to place the tubes. If a nasogastric tube is incorrectly inserted there could be damage to the vocal cords, lungs or the trachea, leading to grave injury or even death.
According to Avanos' safety communications, there were 60 injuries and 23 deaths related to this incident. There have been several adverse events that occurred, including pneumothorax, respiratory failure, perforation, pneumonia and pleural effusion.
Cortrak*2 will use this recall to update its instructions for the use and intended usage. Users will need to confirm the proper placement of tubes in accordance with the protocols of institutions before they are able to deliver nutritional supplements.
https://content.govdelivery.com/accounts/USFDA/bulletins/317bc54 Clinicians were also encouraged to attach the amended field notice on the problem to Avanos operating manual and to return the acknowledgement forms that came in Avanos announcement. https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause Avanos is hoping to offer users with updated labeling. This will include confirmation that the placement of the tube was done according to institutional policy.
Homepage: https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause
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