Device recall
Z-2335-2012: The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-2335-2012 |
|---|---|
| Recall event | 62895 |
| Product | The SYSTEM 1E Liquid Sterilant Processing System. The SYSTEM 1E Liquid Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive medical devices, including endoscopes and their accessories. |
| Product code | MED |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 6, 2014 |
| 510(k) numbers | K090036, K101409, K102462 |
| FEI number | 1527821 |
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