[pending] GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to int
Pending LLM rewrite. Source: FDA_DEVICE Z-1734-2025.
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
- GALT Guidewire REF SGW-051-07 Guidewires are intended for use in percutaneous procedures, to introduce and position catheters and other interventional devices within the Coronary and peripheral 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: SGW-051-07 UDI-DI code: 0084126810132 Lot Number: 25050797
Distribution
Distributed nationwide across the United States.
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