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This has resulted in 60 injuries, and 23 deaths.
The FDA has declared this a Class I Recall, the most serious type. The use of these devices could cause serious injury or death.
Avanos Medical Sam Brusco Associates Editor05.16.22
The FDA has confirmed the recall by Avanos Medical of their Cortrak*2 entry access system. Cortrak 2 eternal access system The recall of 629 devices distributed between 2016-2022 began on the 21st of March.
Cortrak*2 helps clinicians place medical feeding tubes inside the stomach or small bowel of patients who require nutrition via tube.
This recall was prompted in response to reports of injuries and deaths in patients due to the incorrect placement of gastric or nasocentric tubes. Cortrak 2 eternal access system https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The device is used to insert these tubes. If a nasogastric, or nasoenteric tube is not correctly inserted it can cause damage to the vocal cords, lungs or the trachea, leading to grave injury or even death.
According to Avanosthe safety announcement, there were 60 deaths and 23 injuries that were related to this issue. Avanos Medical feeding tube The adverse events reported included pneumonia, respiratory failure, perforation and pneumonia, as well as the pleural effusion.
The recall is being used to modify Cortrak*2's directions regarding use and intended usage, instructing users to confirm the placement of the tube based on guidelines for institutions prior to using the tube to deliver nutrition.
Clinicians were advised to attach the corrective field note regarding the issue to their operating manual and to return the acknowledgement form which was enclosed with the notification to Avanos. Avanos is hoping to offer users updated labels. https://www.afslaw.com/perspectives/investigations-blog/medical-device-company-pays-38-million-resolve-criminal-charges This will include confirmation that the placement of the tube was carried out in accordance with institutional policies.
https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical
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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