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Avanos Medical has recalled Cortrak*2 EAS due to reports of deaths and injuries caused by tube misplacements.
Avanos Medical feeding tube The US Food and Drug Administration (FDA), has designated the recall by Avanos Medical of Cortrak*2 Ental Access System, (EAS) as an I class recall.
A Class I remember is the most serious kind out of the three classes.
Avanos Medical Avanos Medical pulled Cortrak* 2 EAS from service after death and injuries of patients due to misplacements of nasogastric tubes.
The device is intended to aid trained health care personnel place medical tubes for feeding inside patients. It also provides live information about the tube's location in real-time. placement.
But, the incorrect positioning of the nasogastric or nasoenteric, tubes can cause serious injury or even death.
https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its In total, the company has recalls 629 devices distributed across the US between 1 April 2016 to 1 January 2022.
The notice of recall issued by the company added that there have been sixty injuries and 23 patient deaths since 2015 due to misplacement of nasogastric feeding tubes while using the Cortrak* 2 EAS.
Avanos Medical Avanos Medical Avanos Medical, following the recall, will update the device’s labelling. This includes updating the instructions and intended applications of Cortrak* 2 EAS.
The updated guidelines require that users confirm the position of tubes in accordance with protocols from their respective institutions prior to making use of the tubes.
Avanos Medical Based in Alpharetta, Georgia, US, Avanos Medical focuses on making medical devices for clinical use. The brand's name is accessible in over 90 countries.
The company agreed to buy OrthogenRx for $160 million in December. Avanos Medical completed the acquisition on January 20.
My Website: https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/press-releases/avanos-medical-inc-pay-22-million-resolve-criminal-charges-related-fraudulent-misbranding-its
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