Red blood cell-recovery autotransfusion system

A red blood cell-recovery autotransfusion system is a medical device assembly that collects blood lost during surgery or trauma, processes it to isolate and wash red blood cells, and prepares them for reinfusion into the same patient. This allows the patient’s own blood to be returned, reducing the need for donor blood transfusions.

These systems are typically supplied as integrated assemblies with disposable components for single-patient use and are regulated based on their function in blood processing and reinfusion. They are not classified as drugs or biologics, and their regulatory status depends on the jurisdiction’s rules for devices that handle and return autologous blood.