Device recall
Z-1497-2017: 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170…
FDA device recall · Class I · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1497-2017 |
|---|---|
| Recall event | 76596 |
| Product | 7F Prelude Short Sheath Introducer. Catalog Numbers: K15-00070, K15-00170, PSS-7F-4-035MT, PSS-7F-4MT. Produc Usage: The Merit Prelude Short Sheath Introducer is intended to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries while maintaining… |
| Product code | DYB |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class I |
| Status | Terminated |
| Termination date | Aug 8, 2017 |
| 510(k) numbers | K082063 |
| FEI number | 1721504 |
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