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Recall Observatory FDA recall evidence

Device 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.

Z-2335-2012

August 01, 2012

Class II

Product summary

Firm
Steris Corporation
Event
Event 62895
Status
Terminated
Classification
Class II
Quantity
6,051 units
Official record key
device-enforcement:Z-2335-2012

Official wording

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.

Code information: Model #: P6500, S/N 400000 through 406294

Distribution pattern: Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.