Recall Z-0823-2011 ยท MLR Sterilizer, Chemical
Steris Corporation
Steris Reliance EPS Endoscope Processing System , manufactured by Corporation STERIS Canada, Quebec, Canada. Washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical endoscope devices.
| Date | Dec 28, 2010 (initiated Jul 2, 2010) |
| Status | Terminated |
| Reason | Reliance EPS had internal water leaks and interrupted cycles when air leaks triggered false Fault 38 alarm that DG/HLD cup has not been replaced. |
| Root cause | Other |
| Action | Steris issued an "Urgent Field Correction Notice" dated July 2, 2010 to each affected US consignee, notifying them of the issue and affected device. Steris Field Service Representatives and Dealers will contact each affected customer to schedule a service visit to install system upgrades. In the event of an interrupted cycle prior to the upgrade, consignees were instructed that the load should be handled in accordance with the Reliance EPS Operators Manual. Steris can be contacted at 440-392-7043. |
| Quantity | 936 |
| Distribution | Worldwide distribution: USA, including states of AK, AL, AZ, CA, CO, DE, FL, ID, IL, KS, KY, MD, MI, MN, MO, NC, NV, NY, OH, PA, SC, VA, WA, WI, and WY, and countries of Algeria, Australia, Belarus, Canada, France, Germany, Greece, India, Italy, Japan, Kuwait, Lebanon, New Zealand, Russian Federati |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K040049 | THE RELIANCE ENDOSCOPE PROCESSING SYSTEM STERIS Corporation, Dec 17, 2004 |