FDA Provides Update on Getinge’s Recall of Its Anesthesia Devices

The FDA has issued an update on Getinge’s May 2 recall of its Flow-c and Flow-e anesthesia systems, deeming it a Class 1 recall because of the risk of serious injury or death.

The systems, which provide inhalation anesthesia and control the ventilation of patients who have no ability or limited ability to breathe, are used in hospitals for patients ranging in age from newborns to adults.

The recall was prompted by reports of cracked or broken on/off switches on the system’s suction unit. If a switch breaks, the suction unit will not work to remove fluids such as phlegm, blood or stomach content from the patient’s mouth or airways. And if the suction device is not working for a long period, the fluids could block a patient’s breathing, the agency said.

There have been 21 complaints, but no injuries or deaths linked with the switch failures, the agency said.