FDA Device recall Z-1733-2025
B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is i…
- FDA Device
- Class II
- ongoing
- Published 2025-05-14
On 2025-05-14 the FDA classified a Class II recall of B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802 Model Number: BCL-100-04 The Elite HV¿ Introducer System is i… by Galt Medical, citing due to a potential open seal in the sterile barrier packaging .
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-1733-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-03-27 |
| Published | 2025-05-14 |
| Last updated | 2026-09-13 11:57 UTC |
| Company | Galt Medical |
| Distribution | US |
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
Due to a potential open seal in the sterile barrier packaging .
Identifiers
| code_info | Catalog Number: 612802 Model Number: BCL-100-04 Lot Number: S25128171 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:57 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-1733-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.