Enforcement Report - Week of September 19, 2012
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Product Detail
| Product Description | 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. |
|---|---|
| Recall Number | Z-2335-2012 |
| Classification | Class II |
| Code Info | Model #: P6500, S/N 400000 through 406294 |
| Product Distributed Qty | 6,051 units |
| Reason For Recall | 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. |
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 | Letter |
| Distribution Pattern | Worldwide Distribution -- USA (nationwide) and the countries of Bahrain and Hong Kong. |
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