Introducer Kit- Tearaway MicroSlide REF KIT-051-01 — Class II medical device recall Z-1737-2025
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-1737-2025 |
|---|---|
| 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 | 490 units |
| Reason classes | sterility, packaging |
| UPC / GTIN / UDI-DI | 00841268106130, 00841268107380 |
| Lot numbers | 24190504, 24284447, 24298473, INT-101-15 |
| Model numbers | 00841268106130, 00841268107380, INT-101-15, KIT-051-01 |
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 all ages.
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-1737-2025. 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.