Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ In…

Recall date

March 27, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-1733-2025

FDA classification

Class II

Brand / firm

Galt Medical Corporation

Sold / distributed

Worldwide - U.S. Nationwide distribution in the states of AL, FL, GA, IL, MA, OH, PA, and UT. The countries of Canada, Ireland, Israel, Korea, Qatar, and United Kingdom.

Why it was recalled

Due to a potential open seal in the sterile barrier packaging .

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.