Device recall
Z-2553-2025: 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2553-2025 |
|---|---|
| Recall event | 97420 |
| Product | 10Fore Hemostasis Valve Catalog Number / UDI-DI code: MAPTEN4 / 00884450821305 MAPTEN42 / 00884450832509 MAPTEN452 / 00884450821329 The 10Fore Hemostasis Valve is intended to maintain hemostasis during the introduction/withdrawal and use of diagnostic and interventional devices. |
| Product code | DTL |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Open, Classified |
| FEI number | 1721504 |
At a glance
- None 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