Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF Recalled by Galt Medical Corporation Due to Due to a potential open seal in the...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Galt Medical Corporation directly.
Affected Products
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.
Quantity: 100 systems
Why Was This Recalled?
Due to a potential open seal in the sterile barrier packaging .
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Galt Medical Corporation
Galt Medical Corporation has 20 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Device). Last updated March 26, 2026. View original report