Device recall
Z-1960-2011: STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E…
FDA device recall · Class II · Steris Corporation Hopkins Facility
Key facts
| Recall number (Z-number) | Z-1960-2011 |
|---|---|
| Recall event | 58290 |
| Product | STERIS SYSTEM 1E Liquid Chemical Sterilant Processing System The SYSTEM 1 E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned impressible, reusable, critical and semi-critical heat sensitive medical devices, including endoscopes and… |
| Product code | MED |
| Recalling firm | Steris Corporation Hopkins Facility |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Mar 13, 2013 |
| 510(k) numbers | K090036, K101409, K102462 |
| FEI number | 3000251274 |
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