The FDA slapped Accutron’s recall of 206 flowmeters with Class I status, the agency’s designation for the most serious type of recall.
The agency warned that the flowmeters, which the company recalled earlier this month over leaking nitrous oxide, could lead to temporary or permanent brain damage or death.
Neither the FDA nor Accutron have received any reports of patient injuries to date, according to the FDA notice.
Accutron recalled its Ultra PC% cabinet mount flowmeters after receiving reports that 2 reports that the devices leaked nitrous oxide after the oxygen flow was switched off.
When not accompanied by oxygen, the stream of nitrous oxide gas could cause brain damage in patients, the company noted.
The recall includes 8 product models and customers can return these flowmeters for free replacement, according to an FDA notice.