FDA Issues Update on Getinge’s Sevoflurane Vaporizer Recall
The FDA has issued on update on Getinge’s Dec. 7 recall of its sevoflurane vaporizers for its Maquet anesthesia machines, deeming it a Class 1 recall because of the risk of serious injury or death.
The Swedish device company issued the recall because of the potential chemical breakdown of sevoflurane, a general surgical anesthetic, that may result in inhalation and/or skin exposure to harmful chemicals. There have been eight reports of a yellow substance in the vaporizer, but no reports of injuries or deaths.
If the chemical breakdown occurs, it may cause serious harm to patients, including irritation of the respiratory tract and lung swelling caused by excess fluid, the FDA said.
The affected devices were manufactured between Dec. 15, 2020, and July 21, 2021, and distributed from Feb. 16 to Oct. 30, 2021.