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 | Letter |
| 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 |
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