—#124471

Product

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.

FDA product code: MLR — Sterilizer, Chemical
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K090036, K101409, K102462, K113520, K131078
Affected lot / code info: Model #6500 & 7500

Why it was recalled

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 (FDA determination)

Device Design

Action the firm took

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 contact STERIS Field Service Dispatch at 1-800-333-8828. For questions regarding this recall call 440-392-7519.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-11-21
Posted by FDA: 2013-12-31
Terminated: 2014-06-16
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124471. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.