[pending] B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-10
Pending LLM rewrite. Source: FDA_DEVICE Z-1733-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Due to a potential open seal in the sterile barrier packaging .
The recalled product
- 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
- Galt Medical Corporation
- Category
- Medical Device — Devices
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171
Distribution
Distributed nationwide across the United States.
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