FDA: Class I recall of Getinge Flow-c, Flow-e Anesthesia Systems

Editor's Note

The Food and Drug Administration (FDA) on July 6 identified the recall by Getinge USA Sales Inc of its Flow-c and Flow-e Anesthesia Systems as Class I, the most serious.

The recall was initiated after reports of cracked or broken on/off switchs on the systems’ suction units. If the switches break, the suction units will not remove fluids, such as phlegm, blood, or gastric content from the patient’s mouth and/or airways, which could block a patient’s breathing and delay a surgical procedure.

To date, there have been 21 complaints, no injuries, and no deaths. Distribution dates were June 2, 2020, to February 15, 2022.