[pending] Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-0
Pending LLM rewrite. Source: FDA_DEVICE Z-1735-2025.
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- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-
- 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 (8)
- UDI-DI code: 00841268104792 Lot Number: G25064259 KIT-002-35
- UDI-DI code: 00841268104808 Lot Number: G25029077 KIT-011-40
- UDI-DI code: 00841268105553 Lot Number: S25031227 KIT-011-62
- UDI-DI code: 00841268105614 Lot Numbers: G25052163 G25080165 KIT-038-04
- UDI-DI code: 00841268104556 Lot Number: G25092186 KIT-039-03
- UDI-DI code: 00841268104587 Lot Numbers: G25050190 G25078192 KIT-039-13
- UDI-DI code: 00841268106055 Lot Number: G25050202 KIT-081-02 / PS2-38
- UDI-DI code: 00841268108394 Lot Number: G25056231
Distribution
Distributed nationwide across the United States.
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