FDA licenses first US freeze-dried plasma product

Overview

Updated Sep 1

For decades, US plasma transfusions required a freezer and time to thaw. Ezplaz, the first US-licensed freeze-dried plasma, reconstitutes in about 2.5 minutes and sits on a shelf for a year.

The shift moves plasma out of the hospital blood bank and into ambulances, combat zones, and disaster sites. The FDA granted the biologics license to Vascular Solutions, a Teleflex subsidiary, after a 12-year research partnership with the Defense Health Agency. The approval covers adults only, and only when frozen plasma is unavailable.

Why it matters

Bleeding patients in combat zones and rural areas can now receive plasma before reaching a hospital blood bank, buying minutes that can decide survival.

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Key Indicators

2.5 min

Reconstitution time

Ezplaz powder mixes with sterile water in about 2.5 minutes, skipping the thaw step frozen plasma requires.

12 months

Room-temperature shelf life

Stored at 2-25°C (36-77°F) and stable through temperature fluctuations, unlike plasma that must stay frozen.

FDA-licensed freeze-dried plasma products in the US

Ezplaz is the first, and Teleflex's first biologics license for a blood component.

1 unit

Plasma per kit

Each kit holds one unit of freeze-dried plasma, a 250 mL bag of sterile water, a transfer set, and a transfusion set.

15 years

Years US special operators used French freeze-dried plasma

Before Ezplaz, the only field option was imported French product brought in case by case under special access.

Voices

Curated perspectives — historical figures and your fellow readers.

Ever wondered what historical figures would say about today's headlines?

People Involved

Karim Mikhail

Acting director, FDA Center for Biologics Evaluation and Research (CBER)

Oversaw the Ezplaz licensure

Anne Eder

Director, FDA Office of Blood Research and Review

Led the blood-product review team for Ezplaz

Jake Newman

President and general manager, Teleflex Global Vascular and Emergency Medicine

Leads commercial rollout of Ezplaz

Pampee Young

Chief medical officer, American Red Cross

Warned the approval won't ease most blood shortages

Kendra Lawrence

Project manager, Warfighter Protection and Acute Care (WPAC), Defense Health Agency

Managed the military side of the Ezplaz partnership

Organizations Involved

U.S. Food and Drug Administration

Federal regulatory agency

Licensed Ezplaz, the first US freeze-dried plasma

The FDA's Center for Biologics Evaluation and Research regulates blood products and issued the Ezplaz license.

Teleflex

Medical technology company

Holds the Ezplaz biologics license through subsidiary Vascular Solutions

Teleflex, based in Wayne, Pennsylvania, owns Vascular Solutions, the subsidiary that holds the Ezplaz license.

Defense Health Agency

Department of Defense health agency

Co-developed Ezplaz through its WPAC program

The Defense Health Agency manages medical care for US service members and ran the military side of the Ezplaz partnership.

American Red Cross

Nonprofit blood supplier

Facing a national blood supply crisis as Ezplaz launches

One of the largest US blood suppliers, the Red Cross declared a national supply crisis weeks before the Ezplaz approval.

Timeline

April 2014 July 2026

4 events Latest: July 29th, 2026 · 1 month ago

Tap a bar to jump to that date

July 2026
FDA licenses Ezplaz, first US freeze-dried plasma
Latest Regulatory

FDA licenses Ezplaz, the first US freeze-dried plasma, for adults when other plasma is unavailable.
July 29th, 2026
Red Cross warns of national blood supply crisis
Context

Red Cross warns donations hit a four-year low; O-positive supply under one day.
July 27th, 2026
December 2017
Congress authorizes military-FDA medical product collaboration
Policy

Congress authorizes military-FDA collaboration to speed products for service members.
December 12th, 2017
April 2014
Vascular Solutions and military sign plasma research pact
Partnership

Vascular Solutions and the Defense Health Agency sign a freeze-dried plasma research pact.
April 1st, 2014

Scenarios

Ezplaz becomes standard plasma for battlefield and prehospital care

Likely Resolves by End of 2027

Discussed by: Teleflex executives, Defense Health Agency officials, and Hemostasis Today

The Defense Health Agency made FDA-approved freeze-dried plasma a top priority, and the 2014 research pact with Vascular Solutions was built for this outcome. With a US license, procurement no longer depends on case-by-case import authorizations, which Hemostasis Today analyst Reza Shojaei says changes the conversation. Teleflex says the kit is designed for air and road ambulances, hospitals, and battlefields.

Ezplaz rollout stalls, frozen plasma keeps its role

Possible Resolves by End of 2027

Discussed by: MedicalDaily and American Red Cross chief medical officer Pampee Young

Licensure is not availability. MedicalDaily notes Ezplaz still needs manufacturing scale-up, distribution, stocking, and protocol changes before patients see it. The indication is narrow, and the FDA did not establish that Ezplaz improves survival compared with frozen plasma. Young says most US shortages involve red blood cells and platelets, not plasma.

FDA expands Ezplaz to children or routine use

Uncertain Resolves by End of 2028

Discussed by: FDA officials and MedPage Today

The current license covers adults only when other plasma is unavailable, and pediatric use is excluded. Broadening the indication would require new studies; the FDA explicitly did not find Ezplaz superior to frozen plasma. If field experience is positive and Teleflex runs additional trials, the label could widen.

Historical Context

3 moments from history that rhyme with this story — and how they unfolded.

1940-1945

World War II dried plasma (1940s)

The US pioneered dried plasma in World War II, shipping large quantities to field hospitals to treat shock and hemorrhage. The process pooled plasma from many donors.

Then

Hepatitis outbreaks traced to pooled plasma led the US military to abandon dried plasma after the war.

Now

The US shifted to frozen single-donor plasma with viral screening, while some foreign militaries kept freeze-dried plasma in use.

Why this matters now

Ezplaz brings back a technology the US invented and abandoned, this time with single-donor sourcing and modern testing.

December 2017

Public Law 115-92 (2017)

Congress directed the Department of Defense and the FDA to collaborate on speeding up development and review of products for serious conditions facing service members. Freeze-dried plasma was among the first products identified under the law.

Then

The FDA issued guidance in 2019 for manufacturers developing dried plasma products.

Now

The law created a formal review track that carried Ezplaz from a 2014 research pact to a 2026 license.

Why this matters now

It is the institutional mechanism behind this approval.

2000s-2026

French military freeze-dried plasma (2000s-2026)

France's armed forces have used freeze-dried plasma for decades. US special operations forces carried French-made FDP for 15 years, importing it case by case under special access because no US-licensed product existed.

Then

The imported product proved freeze-dried plasma works in the field but lacked a US regulatory license.

Now

US reliance on imports left a supply gap the Defense Health Agency pushed to close with a domestic product.

Why this matters now

Ezplaz replaces an import-dependent workaround with a US-licensed product, changing procurement and supply reliability.