BEUDAMED
    FDA Enforcement Class II Terminated

    VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.

    Recall: Z-1166-2014 · Reported March 19, 2014

    Enforcement

    Recall Number
    Z-1166-2014
    Event ID
    67308
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Steris Corporation
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 19, 2014
    Initiation Date
    December 19, 2013
    Classification Date
    March 10, 2014
    Termination Date
    March 26, 2014
    Address
    5960 Heisley Rd, N/A, Mentor, OH, 44060-1834, United States

    Description

    VERIFY¿ SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY¿ SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270¿F using typical healthcare dynamic air removal steam sterilization cycles.

    Reason

    STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY¿ SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A.

    Code Info

    Model LCC019, Lot #: 024552A

    Distribution

    Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada. Product was also shipped to Canada.

    Quantity

    94 boxes/20 units