B Braun Interventional ELITE HV Hemostasis Valve Introducer System… — Class II medical device recall Z-1733-2025
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-1733-2025 |
|---|---|
| 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 | 100 systems |
| Reason classes | sterility, packaging |
| Lot numbers | S25128171 |
| Model numbers | 612802, BCL-100-04 |
Product
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is indicated for use in percutaneous procedures to introduce catheters and other intravascular devices into the vasculature.
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-1733-2025. 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.