Device recall
Z-1157-2012: SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR…
FDA device recall · Class II · Sorin Group USA, Inc.
Key facts
| Recall number (Z-number) | Z-1157-2012 |
|---|---|
| Recall event | 61208 |
| Product | SORIN GROUP, Distributed by: Sorin Group USA, Inc., Arvada, CO 80004, USA, SDR S5 MAST ROLLER PUMP 85, Made in Germany, 1 UNITS PER CASE, CATALOG/PART No.: 50-80-70 The S5 System is used to perform, control and monitor extracorporeal blood circulation during an operation for up to six hours. |
| Product code | DTQ |
| Recalling firm | Sorin Group USA, Inc. |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Nov 9, 2012 |
| 510(k) numbers | K060053 |
| FEI number | 1718850 |
At a glance
- 1–9 Linked 510(k)s
- 10–99 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