Device recall
Z-1452-2012: Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3…
FDA device recall · Class II · Terumo Cardiovascular Systems Corporation
Key facts
| Recall number (Z-number) | Z-1452-2012 |
|---|---|
| Recall event | 60774 |
| Product | Sarns Modular Perfusion System 8000 Catalog number 148689 or 78-8067-3878-3 Temperature-Pressure Board, Cardioplegia Monitor (service part only) The 8K Arterial Monitor is intended for use with the 8000 Modular Perfusion System to display one average pressure and three average temperatures and also… |
| Product code | DTQ |
| Recalling firm | Terumo Cardiovascular Systems Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 11, 2013 |
| 510(k) numbers | K915183 |
| FEI number | 1828100 |
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