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Terminated

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 Recall Z-3124-2011 · Posted 2011-09-01

Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeMLR
Date Initiated2011-08-11
Date Terminated2013-03-19
Product Quantity2,235 units

Reason for Recall

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

Firm Action

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.

Root Cause

Other

Distribution Pattern

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

Related FDA 510(k) Records

Devices referenced by this recall via K-numbers.

K102462SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEMSTERIS Corporation · 2010-09-21K101409SYSTEM IE LIQUID CHEMICAL CTERILANT PROCESSING SYSTEMSTERIS Corporation · 2010-08-02K090036SYSTEM 1.5 STERILE PROCESSING SYSTEMSTERIS Corporation · 2010-04-05

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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