—#103574

Product

SYSTEM 1E Liquid Chemical Sterilant Processing System, Model # P6500, S/N: 400001 through 405005; Mfr. By: STERIS Corporation, Mentor, OH 44060. Product Usage: 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
Affected lot / code info: Model # P6500, S/N: 400001 through 405005

Why it was recalled

STERIS learned that SYSTEM 1E users may experience aborted cycles due to a failure within the UV light system.

Root cause (FDA determination)

Other

Action the firm took

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.

Recalling firm

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

Distribution

Distribution pattern: Worldwide Distribution - USA (nationwide) and the country of Bahrain.

Timeline

Recall initiated: 2011-08-11
Posted by FDA: 2011-09-01
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103574. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.