FDA Device recall Z-0616-2014
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilan…
- FDA Device
- Class II
- terminated
- Published 2014-01-08
On 2014-01-08 the FDA classified a Class II recall of SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH The SYSTEM 1E Liquid Chemical Sterilan… by Steris, citing customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use sol….
Read the official FDA Device notice
| Agency | FDA Device |
|---|---|
| Recall number | Z-0616-2014 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-11-21 |
| Published | 2014-01-08 |
| Last updated | 2026-09-13 11:53 UTC |
| Company | Steris |
| Distribution | US |
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 medical devices, including endoscopes and their accessories.
Reason
Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts.
Identifiers
| code_info | Model #6500 & 7500 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:53 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-0616-2014%22
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