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There have been 60 injuries and 23 deaths due to this issue.
The FDA has classified this as an Class I recall, the most serious kind of recall. These devices can lead to severe injuries or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical's recall of their Cortrak*2 intramuscular access device. 629 devices manufactured between 2016 and 2022 were recalled in the U.S., beginning on March 21.
Cortrak*2 helps clinicians place medical feeding tubes inside the stomachs or small bowels of patients who require to be fed by the tube.
This recall was prompted because of reports of injuries and death in patients following the incorrect placement of gastric or nasocentric tubes. The device is used to position these tubes. A nasogastric, or nasoenteric, tube that is not correctly inserted could result in damage to the vocal chords and the trachea. Avanos Mediacal Cortrak 2 It could result in serious injuries, or death.
Avanos Medical feeding tube https://www.fda.gov/medical-devices/medical-device-recalls/avanos-medical-recalls-cortrak2-enteral-access-system-risk-misplaced-enteral-tubes-could-cause According to Avanos the safety announcement There have been 60 injuries and 23 deaths related to this issue. Adverse events reported included pneumothorax, respiratory failure perforation, pneumonia and the development of pleural effusion.
feeding tube placement The recall is used to revise Cortrak*2's guidelines on use and intended use, instructing users to confirm the placement of the tube according to protocol guidelines before using the tube to distribute nutrients.
Avanos Mediacal Cortrak 2 Clinicians were also encouraged to add the updated note in the field on the issue to Avanos' operating manual, and to return the acknowledgment forms that came with Avanos' announcement. Avanos Medical feeding tube Avanos Medical The company plans to give users an updated labeling, including confirmation of the placement of tubes in accordance with the institution's policies prior to usage.
Avanos Mediacal Cortrak 2
Website: 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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