Notes

Avanos Medical faces Class I recall for feeding tube system linked to 23 deaths in 2015

After seven years during which Avanos Medical's enteral tube placement system was plagued with unlucky luck and mishaps, the FDA has given its most severe instruction for a recall.

Cortrak*2 Enteral Access System consists of an electromagnetic stylet, an external receiver with an LCD monitor. The system can be utilized in conjunction with the system to stream a live video that shows the procedure of inserting a medical feeding tube in the stomach of a patient. This is done with the aim of improving accuracy and reducing complications.

Avanos was not happy with the mission and launched an recall of all Cortrak*2 units between January 2021 and January 2022. The recall included nearly 630 devices which were distributed between April 2016 & the start of this year.

RELATED
Promising greater safety, a tiny gadget can create chaos for tube feeders
The safety event isn't a recall in the strict sense of the word: Avanos is not asking health professionals to return the devices back to the manufacturer, but to ensure that they're using them correctly.

A feeding tube that isn't properly inserted could result in serious injury or even death. Avanos reported 60 injuries and 23 deaths since 2015, FDA said. All of these were directly related to the FDA's Cortrak*2 system that is used to insert the feeding tube.

A variety of injuries have been documented, which include respiratory failure (collapsed lung) lung infection, holes inside the esophagus and walls.

feeding tube placement According to FDA Avanos, a Georgia-based business issued a field correction note reminding users to confirm the placement of nasogastric and nasoenteric tubs according to institutional guidelines. Avanos Medical They've also been asked to attach the safety warning to the operating manual of the system and to confirm with Avanos that they have received the update.

Avanos indicated that it will shortly issue new labels for the device. Avanos Mediacal Cortrak 2 These will include the instructions for where to put the tube, in accordance with the company's policies.

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 RELATED
FDA orders Philips to repair, replace or refund all ventilators recalled by FDA
This is the FDA's second warning of the year for enteral feeding tubes. feeding tube placement feeding tube placement In February, the FDA put out a safety message warning healthcare providers and parents of the possibility of strangulation in children who use feeding tubes.

After two deaths in 2021, the notification was issued. A tubing system wasn't being closely monitored by the staff or caregivers placed around the necks and necks of children under two years old.

"The FDA believes that death or serious injury resulting caused by strangulation with tubing used for enteral feeding for children is extremely rare. But, healthcare providers, and caregivers, should be aware of the possibility that these incidents could and do occur," the FDA said in the notice. The FDA said that similar cases could not yet be reported to FDA.


Website: https://www.weitzlux.com/firm-news/cortrak2-enteral-access-system/