Device recall
Z-0616-2014: SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS…
FDA device recall · Class II · Steris Corporation
Key facts
| Recall number (Z-number) | Z-0616-2014 |
|---|---|
| Recall event | 67002 |
| Product | SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilant Processing System is intended for the liquid chemical sterilization of manually cleaned immersible and reusable critical and semi-critical heat sensitive… |
| Product code | MLR |
| Recalling firm | Steris Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jun 16, 2014 |
| 510(k) numbers | K090036, K101409, K102462, K113520, K131078 |
| 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