Device recall
Z-1733-2025: B Braun Interventional ELITE HV Hemostasis Valve Introducer System REF 612802…
FDA device recall · Class II · Galt Medical Corporation
Key facts
| Recall number (Z-number) | Z-1733-2025 |
|---|---|
| Recall event | 96622 |
| 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. |
| Product code | DYB |
| Recalling firm | Galt Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K043525 |
| FEI number | 3000718472 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database