Recall Z-3124-2011 ยท MLR Sterilizer, Chemical
Steris Corporation
SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: 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 th
| Date | Sep 1, 2011 (initiated Aug 11, 2011) |
| Status | Terminated |
| Reason | STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system. |
| Root cause | Other |
| Action | STERIS sent an "Urgent Field Correction Notice" letter dated July 2011 to all affected customers. The letter describes the product, problem and actions to be taken. The letter states that STERIS Service Representative will contact customers to schedule the repair of the recalled product. For further information or questions contact STERIS Field Service Dispact at 1-800-333-8828. |
| Quantity | 2,235 units |
| Distribution | Worldwide Distribution - USA (nationwide) and the country of Bahrain. |
| FDA record | Open on fda.gov |