Recall Z-0616-2014— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2013-11-21, terminated 2014-06-16. It names 5 FDA 510(k) clearances: K131078, K113520, K102462 and 2 more. 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..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2013-11-21
- Terminated
- 2014-06-16
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
5 on FDA's record- K131078 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K113520 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K102462 — SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM
- K101409 — SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM
- K090036 — SYSTEM 1.5 STERILE PROCESSING SYSTEM
K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product description
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 for recall
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.