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Avanos Medical recalled Cortrak* 2 EAS after incidents of injury and patient deaths caused by tube missing.
Avanos Mediacal Cortrak 2 The US Food and Drug Administration has identified Avanos Medical's Cortrak*2 entry access system (EAS) to be recalled as an Class II recall.
The most severe of the three kinds is a Class I recall.
Avanos Medical pulled Cortrak* 2 EAS off service following death and injuries of patients due to nasogastric tubes misplacements.
Avanos Medical The device is intended to help medical professionals who are trained to place medical tubes for feeding in patients and offer real-time location information on tube placement.
Avanos Mediacal Cortrak 2 However, incorrectly installed nasogastric/nasoenteric pipe could cause harm to vocal cords, or the trachea. feeding tube placement This can lead to grave injuries or even death.
The recall covers 629 devices that were available in the US between 1 February 2016 until 1 January 2022.
The company also noted in a recall communication that there had been 60 injuries and 23 patients that died in 2015 as a result of the incorrect placement of nasogastric feed tubes when using the Cortrak* 2 EAS.
Avanos Medical feeding tube https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Avanos Medical, following the recall, will revise the device's labelling. This includes changing the instruction for use and intended uses of Cortrak* 2 EAS.
These revised guidelines direct users to verify tube placement in accordance with the protocol of the institution's prior use.
Avanos Medical is based in Alpharetta (Georgia), USA. It is a specialist in the production of medical devices. https://www.hpra.ie/docs/default-source/field-safety-notices/april-2022/v50968_fsn.pdf?sfvrsn=2 The company's recognized brands are accessible in more than 90 countries.
The company signed an agreement with OrthogenRx to purchase the company for $160 million in a transaction. Cortrak 2 eternal access system Avanos Medical successfully closed the acquisition of OrthogenRx in January.
Homepage: https://www.ormanager.com/briefs/fda-updates-safety-alert-for-cortrak-2-enteral-access-system/
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