FDA-Device2012-09-19Class II
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.
Steris Corporation
Hazard
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.
Sold states
Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.
Affected count
6,051 units
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2335-2012Don't want to check this manually?
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