Device recall
Z-0519-2010: Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-0519-2010 |
|---|---|
| Recall event | 53557 |
| Product | Merit Medical Systems, Inc. Prelude Pro Sheath Introducer REF/CAT No.: PRO-6F-11-035 Prelude PRO SHEATH INTRODUCER 6F 11 cm to provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries. |
| Product code | DRE |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Dec 15, 2009 |
| 510(k) numbers | K050962 |
| FEI number | 1721504 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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