—#93052

Product

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.

FDA product code: MLR — Sterilizer, Chemical
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K040049
Affected lot / code info: Model #'s: MB30001, MB30002, MB30003, MB000077, MB000078, MB000079, MB000080 & MB000081

Why it was recalled

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 (FDA determination)

Other

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060

Distribution

Distribution pattern: 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 Federation, Saudia Arabia, Spain, Turkey, United Arab Emirates and United Kingdom.

Timeline

Recall initiated: 2010-07-02
Posted by FDA: 2010-12-28
Terminated: 2012-09-27
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #93052. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.