PlainRecalls
FDA Devices Moderate Class II Terminated

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.

Reported: January 8, 2014 Initiated: November 21, 2013 #Z-0616-2014

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.

Details

Recalling Firm
Steris Corporation
Units Affected
6,028 units
Distribution
Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom.
Location
Mentor, OH

Frequently Asked Questions

What product was recalled? ▼
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.. Recalled by Steris Corporation. Units affected: 6,028 units.
Why was this product recalled? ▼
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.
Which agency issued this recall? ▼
This recall was issued by the FDA Devices on January 8, 2014. Severity: Moderate. Recall number: Z-0616-2014.

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