Device recall
Z-1735-2025: Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34…
FDA device recall · Class II · Galt Medical Corporation
Key facts
| Recall number (Z-number) | Z-1735-2025 |
|---|---|
| Recall event | 96622 |
| Product | Introducer Kit- Coaxial Dilator REF: KIT-002-28, 00841268104730 KIT-002-34, 00841268104792 KIT-002-35, 00841268104808 KIT-011-40, 00841268105553 KIT-011-62, 00841268105614 KIT-038-04, 00841268104556 KIT-039-03, 00841268104587 KIT-039-13, 00841268106055 KIT-081-02 / PS2-38, 00841268108394 These… |
| Product code | OFL |
| Recalling firm | Galt Medical Corporation |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 3000718472 |
At a glance
- None Linked 510(k)s
- 1–9 Products in the same recall event
- 1–9 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