[pending] Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of gui
Pending LLM rewrite. Source: FDA_DEVICE Z-1736-2025.
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
- Introducer Needle REF NDL-107-04 These needles are used for the percutaneous introduction of guidewires
- 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: NDL-107-04 UDI-DI code: 00841268102729 Lot Number: 24108670
Distribution
Distributed nationwide across the United States.
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