Recall Z-2335-2012— Steris Corporation
Class II · Terminated
Class II FDA medical device recall by Steris Corporation, initiated 2012-08-01, terminated 2014-06-06. It names 3 FDA 510(k) clearances: K102462, K101409, K090036. 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.. Reason: The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property..
- Recalling firm
- Steris Corporation
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-08-01
- Terminated
- 2014-06-06
- Firm location
- Mentor, OH, United States
510(k) clearances named in this recall
3 on FDA's record- 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
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.
Reason for recall
The firm initiated a recall after complaint investigations revealed that when the units are left on and not in use at night and/or on weekends the hose disconnects/separates resulting in water leakage that can cause damage to property.
Data sourced from openFDA. This site is unofficial and independent of the FDA.