BEUDAMED
    FDA Recall Terminated

    Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.

    Recall: Z-2263-2013 · Initiated August 29, 2013

    Recall

    Recall Number
    Z-2263-2013
    Event Number
    66247
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    NZA
    Status
    Terminated
    Root Cause
    Use error
    Initiated
    August 29, 2013
    Posted
    September 20, 2013
    Terminated
    July 3, 2014
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Reliance Endoscope Processing System (REPS), STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060-1834 USA www.steris.com. The intended use of the REPS is washing and high level disinfection of up to two manually pre-cleaned, immersible, reusable, heat-resistant, semi-critical devices.

    Reason

    The air pipe that delivers unfiltered ambient air from the procedure room into the water bottle on the listed FUJINON G5 & G8 type flexible GI endoscopes does not connect to the main air/water channel within the light guide (LG) connection head and, as a result, the air pipe does not receive forced flow during the Reliance EPS processing cycle.

    Action

    Steris sent an "URGENT PRODUCT SAFETY NOTICE" dated September 5, 2013 to all affected customers. The letter identified the product, problem, and actions to be taken by the customers.

    Distribution

    Worldwide Distribution-USA (nationwide) including the states of AK, CO, FL, GA, HI, ID, IL, KS, LA, MD, MN, MO, MT, NE, NM, OH, PA, SC, UT, & WY and the countries of Australia, Canada & Spain.

    Quantity

    266 units