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U.S. Department of Health and Human Services

Enforcement Report - Week of September 19, 2012

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Event Detail

Event ID 62895
Product Type Devices
Status Ongoing
Recalling Firm Steris Corporation
City Mentor
State OH
Country US
Voluntary/Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-08-01
Initial Firm Notification of
Consignee or Public
Distribution Pattern Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong.

Product Detail

Product Description Code Info Classification Reason for Recall Product Quantity Recall Number
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. Model #: P6500, S/N 400000 through 406294 Class II 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. 6,051 units Z-2335-2012