Home / Recalls / Medical Devices
Galt Medical Corporation recalls B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV
Recalled May 14, 2025 · FDA recall Z-1733-2025 · Galt Medical
Hazard
Due to a potential open seal in the sterile barrier packaging . · FDA Class II
Units
100 systems
Sold at
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.
Description
Due to a potential open seal in the sterile barrier packaging .
Product
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.
Manufacturer(s)
Galt Medical Corporation
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →