[pending] B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 T
Pending LLM rewrite. Source: FDA_DEVICE Z-1732-2025.
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 Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick.
- Manufacturer
- Galt Medical Corporation
- Category
- Medical Device — Devices
Distribution
Distributed nationwide across the United States.
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