Device recall
Z-1328-2012: Control panel for mast roller pump 85 The S5 Perfusion System is used to…
FDA device recall · Class II · Sorin Group Deutschland GmbH
Key facts
| Recall number (Z-number) | Z-1328-2012 |
|---|---|
| Recall event | 61375 |
| Product | Control panel for mast roller pump 85 The S5 Perfusion System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six (6) hours. |
| Product code | DTQ |
| Recalling firm | Sorin Group Deutschland GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 27, 2012 |
| 510(k) numbers | K071318 |
| FEI number | 3002808267 |
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