Device recall
Z-1828-2015: Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only…
FDA device recall · Class II · Terumo Cardiovascular Systems Corp
Key facts
| Recall number (Z-number) | Z-1828-2015 |
|---|---|
| Recall event | 71196 |
| Product | Custom Cardiovascular Procedure Kits; Over-Pressure Safety Valves. For use only in the extracorporeal circuit for the cardiopulmonary bypass procedures for which the user designed it. |
| Product code | DTL |
| Recalling firm | Terumo Cardiovascular Systems Corp |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 27, 2015 |
| 510(k) numbers | K820297 |
| FEI number | 1000149028 |
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