BEUDAMED
    FDA Recall Terminated

    Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.

    Recall: Z-1190-2008 · Initiated February 19, 2008

    Recall

    Recall Number
    Z-1190-2008
    Event Number
    46753
    Firm
    Steris Corp
    FEI Number
    1527821
    Product Code
    MED
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    February 19, 2008
    Posted
    August 5, 2008
    Terminated
    February 24, 2012
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    Description

    Steris C1160 Universal Flexible Processing Tray, for use with STERIS SYSTEM 1 Processor, used for sterilization of flexible endoscopes.

    Reason

    Failure to effectively sterilize: Under certain conditions, the design/operation of the C1160 Tray may compromise the ability of the SYSTEM 1 processor to correctly assess the state of the high pressure pump during the Sterile Cycle. The L6 sensor fails to alarm when the high pressure pump is not working properly.

    Action

    Steris sent an Urgent Safety Alert/Recall letter dated 2/8/2008, to all customers. The letter stated that any device sterilized in the C1160 Tray should not be used clinically prior to a completion of a successful diagnostic cycle. Until further notice, you must run a diagnostic cycle after each sterile cycle involving a C1160 tray or alternately you must discontinue use of these trays. Steris service technicians will schedule visits to correct the problem.

    Distribution

    Worldwide Distribution, including USA, Puerto Rico, Canada, and Japan.

    Quantity

    28,766 units