Device recall
Z-0068-2019: Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde…
FDA device recall · Class II · Surge Medical Sales, LLC (DBA Surge Cardiovascular)
Key facts
| Recall number (Z-number) | Z-0068-2019 |
|---|---|
| Recall event | 81042 |
| Product | Retrograde Cardioplegia Cannula, Model Number RMG-0015S The Retrograde Cardioplegia Cannula is intended for use in perfusing cardioplegia solutions retrograde through the coronary sinus by means of transatrial introduction. |
| Product code | DWF |
| Recalling firm | Surge Medical Sales, LLC (DBA Surge Cardiovascular) |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Apr 4, 2019 |
| 510(k) numbers | K964199 |
| FEI number | 3004986960 |
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