Device recall
Z-1737-2025: Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15…
FDA device recall · Class II · Galt Medical Corporation
Key facts
| Recall number (Z-number) | Z-1737-2025 |
|---|---|
| Recall event | 96622 |
| Product | Introducer Kit- Tearaway MicroSlide REF KIT-051-01, 00841268106130 INT-101-15, 00841268107380 These introducers are used for the procedures to introduce catheters and other intravascular devices into the coronary and peripheral vasculature of adult and pediatric patients of all ages. |
| 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