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Avanos Recalls Cortrak*2 Over Potential Enteral Tube Misplacement
This has led to the deaths of 23 people and 60 injuries.

The FDA has identified this as an Class I recall, the most severe type of recall. The use of these devices could result in serious injuries or even death.

Sam Brusco is Associate Editor05.16.22

The FDA has identified Avanos Medical’s recall its Cortrak*2 access device for use in the system. 629 devices made between 2016 and 2022 were recalled, the first recall taking place on March 21.

Cortrak*2 aids clinicians to place medical feeding tubes into the stomach or small bowels of patients needing to receive nutrition via the tube.

Cortrak 2 eternal access system https://historyhub.history.gov/external-link.jspa?url=https://www.hpnonline.com/regulatory/article/21267840/fda-class-i-recall-cortrak2-enteral-access-system-by-avanos-medical The recall was initiated in response to reports of injuries and even death among patients after the incorrect placement of gastric or nasocentric tubes. Avanos Medical The device is used to place these tubes. If a nasogastric or nasoenteric tube is incorrectly inserted there could be damage to the vocal cords, lungs, or trachea, resulting in grave injury or even death.

According to Avanos, there have been more than sixty injuries and 23 deaths connected to this problem. http://www.drugoffice.gov.hk/gb/unigb/www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause The adverse events that were identified included respiratory failure, perforation, and pneumonia, as well as the pleural effusion.

feeding tube placement Cortrak*2 will make use of the recall to revise its guidelines for use and intended use. It will also instruct users to verify tube placement with the help of institutional protocols prior to providing nutritional supplements.

Cortrak 2 eternal access system Clinicians were urged to attach the corrective field notice about the issue in their operating manual and to return the acknowledgement form which was included with the notification to Avanos. Users will soon receive updated labeling and confirmation that tubes were placed in accordance with institution guidelines.

Avanos Medical https://www.fcc.gov/fcc-bin/bye?https://www.medicaldevice-network.com/news/fda-avanos-medical-cortrak2-eas-recall/
Homepage: http://www.bsaa.edu.ru/bitrix/rk.php?goto=https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfRES/res.cfm