SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corpor
FDA device recall Z-3124-2011 · posted 2011-09-01 · Terminated
Recall details
- Recalling firm
- Steris Corporation
- Reason for recall
- STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.
- Action taken
- 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.
- Root cause
- Other
- Status
- Terminated
- Product code
- MLR
- Quantity affected
- 2,235 units
- Distribution
- Worldwide Distribution - USA (nationwide) and the country of Bahrain.
- Date initiated
- 2011-08-11
- Date posted
- 2011-09-01
- Date terminated
- 2013-03-19
- Location
- Mentor, OH
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM (K102462) | STERIS Corporation | 2010-09-21 |
| SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM (K101409) | STERIS Corporation | 2010-08-02 |
| SYSTEM 1.5 STERILE PROCESSING SYSTEM (K090036) | STERIS Corporation | 2010-04-05 |