Device recall
Z-1766-2017: The PreludeSYNC Radial Compression Device is a sterile, single use disposable…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1766-2017 |
|---|---|
| Recall event | 76762 |
| Product | The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization procedures. It has a soft wristband with a secure hook and loop fastener. The band delivers adjustable… |
| Product code | DXC |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 21, 2017 |
| 510(k) numbers | K162988 |
| FEI number | 1721504 |
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