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There are 60 reported injuries and 23 deaths related to this problem.
Avanos Mediacal Cortrak 2 The FDA has identified this as an Class I recall, which is the most serious kind of recall. These devices could cause serious injury or even death.
Sam Brusco, Associate Editor05.16.22
The FDA has identified Avanos Medical as the one responsible for recalling its Cortrak*2 system of access to the enteral. 629 devices distributed between 2016 and 2022 were recalled within the U.S., beginning on March 21.
Cortrak*2 allows clinicians to place medical feeding tubes into the small bowel or stomach of patients that require nutrition.
Avanos Medical feeding tube The recall was caused by reports of death and injuries from patients after nasocentric/nasogastric tube misplacement. This device is utilized for helping to place the tubes. If a nasogastric tube is not correctly inserted, damage can occur to the vocal cords, lungs or the trachea, leading to serious injury or death.
According to Avanos Safety Communication the company has reported 53 deaths and 60 injuries in connection with this incident. Many adverse events were identified such as respiratory failure, pneumonia and pneumothorax.
Cortrak*2 is using the recall to make updates to its guidelines for use. The new instructions include instruction to users to make sure that tubes are set up according to institution protocols before using them to deliver nutrition.
Clinicians were also encouraged to attach the amended field notice on the issue to Avanos operating manual and to return the acknowledgment forms included in Avanos' notice. Avanos Medical https://www.mpo-mag.com/contents/view_breaking-news/2022-05-16/avanos-recalls-cortrak2-over-potential-enteral-tube-misplacement Avanos plans to offer users the most current labels, as well as confirmation of the placement of the tube according to the policies of the institution.
Avanos Medical feeding tube
Read More: https://www.fiercebiotech.com/medtech/avanos-medical-faces-class-i-recall-feeding-tube-system-linked-23-deaths-2015
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