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Recall Observatory FDA recall evidence

Device 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.

Z-0616-2014

November 21, 2013

Class II

Product summary

Firm
Steris Corporation
Event
Event 67002
Status
Terminated
Classification
Class II
Quantity
6,028 units
Official record key
device-enforcement:Z-0616-2014

Official wording

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.

Code information: Model #6500 & 7500

Distribution pattern: 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.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.