Device recall
Z-0142-2014: S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The…
FDA device recall · Class II · Sorin Group Deutschland GmbH
Key facts
| Recall number (Z-number) | Z-0142-2014 |
|---|---|
| Recall event | 66464 |
| Product | S5 Heart-lung machine, Stockert S5 System. Catalogue No: 48-30/40/50-00. The Stockert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six(6) hours or less. |
| Product code | DTQ |
| Recalling firm | Sorin Group Deutschland GmbH |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 10, 2014 |
| 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