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This issue has been responsible for the deaths of 60 and 23 injuries.
The FDA has declared this to be an Class I recall, which is the most serious type of recall. These devices can lead to severe injuries or even death.
Sam Brusco Associate Editor05.16.22
The FDA has confirmed Avanos Medical's recall of the Cortrak*2 oral access system. Avanos Medical feeding tube The recall of 629 devices distributed between 2016 and 2022 started on the 21st of March.
Avanos Medical Avanos Medical feeding tube Cortrak*2 is a device that allows doctors to insert medical feeding tubes in patients' stomachs or small bowels.
The recall was initiated because of reports of injuries and deaths in patients due to the incorrect placement of gastric or nasocentric tubes. The device is used to position these tubes. If a nasogastric, or nasoenteric tube is incorrectly inserted it can cause damage to the vocal cords, lungs or trachea, resulting in grave injury or even death.
Avanos Medical feeding tube According to Avanos reports, there were a total of 60 injuries and 23 deaths in connection with this issue. Pneumothorax (perforation), pneumothorax (perforation) pneumonia, and pleural effusion have all been listed as adverse events.
Cortrak*2 has utilized the recall process to make revisions to its procedures for its use. Cortrak 2 eternal access system Avanos Medical The new instructions include instruction to users to make sure that tubes are placed according to institution protocols before applying them to provide nutrition.
Clinicians were instructed to add the relevant field correction notice to the operating manual. https://www.justice.gov/usao-ndtx/pr/avanos-medical-pay-22-million-resolve-criminal-charge-related-fraudulent-misbranding They should also return the acknowledgement slip that came with the Avanos notice. Avanos will shortly be able to send out updated labeling for users, which will include confirmation of tube placement as per institutional policies.
My Website: https://medicaldevices.icij.org/events/hkg-cortrak-2-enteral-access-system-eas
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