Device recall
Z-2532-2025: Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer…
FDA device recall · Class II · Contract Medical International GmbH
Key facts
| Recall number (Z-number) | Z-2532-2025 |
|---|---|
| Recall event | 97423 |
| Product | Brand Name: Fortress Introducer Sheath System Product Name: Fortress Introducer Sheath System Model/Catalog Number: 386594 Product Description: Fortress Introducer Sheath System, 6F Straight 45cm: |
| Product code | DYB |
| Recalling firm | Contract Medical International GmbH |
| Recall class | Class II |
| Status | Open, Classified |
| 510(k) numbers | K153197 |
| FEI number | 3003637635 |
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