Overview
- The FDA granted a biologics license to Vascular Solutions, a Teleflex subsidiary, on Wednesday, July 29, 2026, authorizing Ezplaz for transfusion in adults when other plasma products are unavailable.
- Ezplaz is freeze-dried so it can be stored at room temperature and quickly reconstituted at the bedside, and it is packaged in a plastic bag with sterile water and transfer and transfusion sets for rapid use.
- The product is made from a single unit of fresh frozen plasma collected at FDA-licensed blood centers and is supplied in Group AB and Group A low‑titer anti‑B types to reduce risk when used before a patient’s blood type is known.
- The FDA determined Ezplaz is as safe and effective as conventional plasma and said its benefits outweigh its risks, highlighting potential use for life‑threatening bleeding in combat, disaster response, and rural settings with limited hospital infrastructure.
- The approval follows regulatory changes that encouraged emergency-focused products and arrives as the American Red Cross reports a national blood‑supply shortfall, positioning Ezplaz as a contingency option rather than a replacement for standard plasma systems.