Eight Medical Recirculator Lavage Kit Recall is Class 1: FDA

FDA says an Eight Medical 2/5/21 recall of specific lots of its Recirculator 8.0 disposable lavage kit was Class 1. The company recalled 288 devices in the U.S. An FDA recall notice says the kit is used with the company’s hyperthermic perfusion system. It allows the system to circulate warm, sterile solution inside a patient’s chest or abdominal cavity to reach a target temperature during surgery.

The device was recalled because the disposable heating element in the kit may release aluminum into the fluid during warming therapy. “When the fluid circulates through the patient’s body,” the notice says, “the patient can be exposed to high levels of aluminum, which can be toxic and cause serious adverse events including death.”

The agency reports there have been no complaints, injuries, or deaths reported for this incident.