Device recall
Z-1408-2009: 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-1408-2009 |
|---|---|
| Recall event | 51877 |
| Product | 6F Prelude Short Sheath Introducer, 4CM in Length with Marker Tip and 0.038" X 50CM Guide Wire, REF No.: PSS-6F-4-038MT, Sterile EO, Merit Medical Systems, Inc., South Jordan, Utah 84095. To provide access and facilitate the percutaneous introduction of various devices into veins and/or arteries… |
| Product code | DYB |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 9, 2010 |
| 510(k) numbers | K082063 |
| FEI number | 1721504 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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