[pending] Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380
Pending LLM rewrite. Source: FDA_DEVICE Z-1737-2025.
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 Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of
- 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 (3)
- Catalog Number: KIT-051-01
- UDI-DI code: 00841268106130 Lot Numbers: 24298473 24190504 INT-101-15
- UDI-DI code: 00841268107380 Lot Number: 24284447
Distribution
Distributed nationwide across the United States.
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