Recall Z-0616-2014 ยท MLR Sterilizer, Chemical
Steris Corporation
SYSTEM 1E Liquid Chemical Sterilant Processing System, Distributed by STERIS Corporation, Mentor, OH 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 their accessories.
| Date | Dec 31, 2013 (initiated Nov 21, 2013) |
| Status | Terminated |
| Reason | Customers indicated fluctuations in environmental conditions sites and gradual degradation/deformation of check valve o-rings following frequent contact with S40 sterilant use solution result in nuisance aborts. |
| Root cause | Device Design |
| Action | STERIS sent an Urgent Voluntary Field Correction Notice dated November 21, 2013, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed that a STERIS Field Service Representative would contact their facility to schedule installation of the new hardware and updated software on their SYSTEM IE Liquid Chemical Sterilant Processing System(s). Customers were instructed that they may continue to operate the SYSTEM IE processor prior to the completion of the update. Customers with questions were instructed to |
| Quantity | 6,028 units |
| Distribution | Nationwide Distribution - USA (nationwide) and the District of Columbia and Puerto Rico. Product was also shipped to the following countries: Afghanistan, Bahrain, Hong Kong, Italy, Saudi Arabia, Turkey & United Kingdom. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K090036 | SYSTEM 1.5 STERILE PROCESSING SYSTEM STERIS Corporation, Apr 5, 2010 |
| K101409 | SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEM STERIS Corporation, Aug 2, 2010 |
| K102462 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation, Sep 21, 2010 |
| K113520 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation, Feb 21, 2012 |
| K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM STERIS Corporation, Jul 5, 2013 |