FDA Class I Recall: Eight Medical International recalls Recirculator 8.0 Disposable Lavage Kits
Eight Medical is recalling the Recirculator 8.0 Disposable Lavage Kit because the disposable heating element within the kit may release aluminum into the fluid during warming therapy. When the fluid circulates through the patient’s body, the patient can be exposed to high levels of aluminum, which can be toxic and cause serious adverse events including death. The FDA has identified a Class I recall. Use of these devices may cause serious injuries or death.
The Recirculator 8.0 Disposable Lavage Kit is used with the company’s Hyperthermic Perfusion System. The disposable lavage kit allows the perfusion system to circulate warm, sterile solution inside a patient’s chest (thoracic) or abdominal (peritoneal) cavity to reach a target temperature during surgery.
Lot Numbers: 20021361, 20202106, 20202106, 20018480, 19854186, 20019438, 20018480, 19854186, 19854185, 20202106, 20019438, 19854184, 20202106, 20018480, 20202106, 20018480, 18687686
Distribution Dates: June 7, 2019 to June 7, 2021
