FDA has declared Avanos Medical's Cortrak*2 EAS Recall Class I
Họ tên: Mohr Mcdaniel , Địa chỉ:652 New Brunswick, Email:firstname.lastname@example.org
HỎI: Avanos Medical recalled Cortrak* 2 EAS in the wake of reports of injuries and deaths due to tube misplacements.
The US Food and Drug Administration (FDA) has identified the recall of Avanos Medical's Cortrak* 2 Enteral Access System (EAS) as Class I recall.
A Class I recall refers to the most severe of three classes.
Avanos Medical recalled Cortrak* 2 EAS in the wake of incidents of injury and patient deaths due to nasoenteric or Nasogastric tube misplacements.
The device is able to assist trained healthcare professionals to insert medical feeding tubes in patients. It also provides real-time details about the placement of tubes.
However, the wrong placement of the nasogastric or nasoenteric tubes could cause serious injury or even death.
Avanos Medical feeding tube Avanos Medical The company has recalled 629 devices throughout the US between January 2016 and January 2022.
The recall notice from the company stated that 60 patients suffered injuries and 23 died due to misplacement in nasogastric tubes while using Cortrak* 2 EAS.
Avanos Medical is updating the marking on the device following the recall. This will include updating the instruction on how to use the device as well as the intended use of Cortrak*2 EAS.
feeding tube placement These updated guidelines require users to verify tube placement according to the institution's protocols prior to use.
https://static.foxnews.com/foxnews.com/content/uploads/2022/04/Avanos_CORTRAK2_Field_Correction_Letter.pdf Avanos Medical is based in Alpharetta (Georgia) in the United States. Its focus is on the production of medical devices. Avanos Medical Avanos Medical markets its well-known brands in over 90 countries.
The company came to an agreement with OrthogenRx to acquire the company in a $160 million transaction. https://americanews.news/avanos-medical-recalls-cortrak-2-enteral-access-system-for-risk-of-misplaced-enteral-tubes-could-cau-14041.html Avanos Medical successfully closed the acquisition of OrthogenRx in January.