Device recall
Z-2426-2018: Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter…
FDA device recall · Class II · Stryker Sustainability Solutions
Key facts
| Recall number (Z-number) | Z-2426-2018 |
|---|---|
| Recall event | 80324 |
| Product | Coronary Sinus (CS) Uni-Directional Diagnostic Electrophysiology (EP) Catheter, catalog numbers D135303 and D135304. Product Usage: The Reprocessed CS Diagnostic EP Catheter is indicated for electrophysiological mapping of cardiac structures; i.e., stimulation and recording only. The catheter is… |
| Product code | NLH |
| Recalling firm | Stryker Sustainability Solutions |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 28, 2020 |
| 510(k) numbers | K100254 |
| FEI number | 3009350690 |
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