Device recall
Z-2238-2021: Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard…
FDA device recall · Class II · Merit Medical Systems, Inc.
Key facts
| Recall number (Z-number) | Z-2238-2021 |
|---|---|
| Recall event | 88315 |
| Product | Prelude SNAP Splittable Sheath Introducer, REF: PLSX -1010, size 10F, Standard Length: 13 cm, CE0344, STERILE EO, Rx Only, (01) 00884450489611. For the introduction of various types of pacing leads and catheters to the heart and coronary venous system. |
| Product code | DYB |
| Recalling firm | Merit Medical Systems, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Feb 24, 2023 |
| 510(k) numbers | K143255 |
| 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