Device recall
Z-1732-2025: B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41…
FDA device recall · Class II · Galt Medical Corporation
Key facts
| Recall number (Z-number) | Z-1732-2025 |
|---|---|
| Recall event | 96622 |
| Product | B Braun Interventional Coaxial Dilator REF: KIT-018-47, KIT-019-67, KIT-018-41, KIT-019-37 These Micro-Introducer Kits are intended to introduce up to a .038 inch guidewire or catheter into the vascular system following a small gauge needle stick. |
| Product code | DRE |
| Recalling firm | Galt Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K000737 |
| FEI number | 3000718472 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 10–99 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