B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL...
FDA Recall #Z-1733-2025 — Class II — March 27, 2025
Product Description
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.
Reason for Recall
Due to a potential open seal in the sterile barrier packaging .
Recalling Firm
Galt Medical Corporation — Garland, TX
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
100 systems
Distribution
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.
Code Information
Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated