Introducer Kit- Coaxial Dilator REF: KIT-002-28 — Class II medical device recall Z-1735-2025
Ongoing recall by Galt Medical Corporation, reported 2025-05-14, distributed nationwide. Due to a potential open seal in the sterile barrier packaging.
| Recall number | Z-1735-2025 |
|---|---|
| Product type | Medical device |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Galt Medical Corporation, Garland, TX, United States |
| Recall initiated | 2025-03-27 |
| Classified | 2025-05-07 |
| Reported by FDA | 2025-05-14 |
| Distributed | Nationwide (US) |
| Countries outside the US | CA, GB, IE, IL, KR, QA |
| Quantity | 4,280 kits |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00841268104556, 00841268104587, 00841268104730, 00841268104792, 00841268104808, 00841268105553, 00841268105614, 00841268106055, 00841268108394 |
| Lot numbers | G25029077, G25038156, G25050190, G25050202, G25052163, G25056231, G25064259, G25078192, G25080165, G25092186, KIT-002-34, KIT-002-35, KIT-011-40, KIT-011-62, KIT-038-04, KIT-039-03, KIT-039-13, KIT-081-02, PS2-38, S25031227 |
| Model numbers | 00841268104556, 00841268104587, 00841268104730, 00841268104792, 00841268104808, 00841268105553, 00841268105614, 00841268106055, 00841268108394, KIT-002-28, KIT-002-34, KIT-002-35, KIT-011-40, KIT-011-62, KIT-038-04, KIT-039-03, KIT-039-13, KIT-081-02, PS2-38 |
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 / PS2-38, 00841268108394 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the peripheral vascular system following a small gauge needle stick.
Reason for recall
Due to a potential open seal in the sterile barrier packaging.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/Z-1735-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.