BEUDAMED
    FDA Recall 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 270F using typical healthcare dynamic air removal steam sterilization cycles.

    Recall: Z-1166-2014 · Initiated December 19, 2013

    Recall

    Recall Number
    Z-1166-2014
    Event Number
    67308
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    JOJ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    December 19, 2013
    Posted
    March 10, 2014
    Terminated
    March 26, 2014
    Address
    5960 Heisley Rd, Mentor, OH, 44060-1834

    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 270F 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.

    Action

    The firm, Steris, sent an "URGENT VOLUNTARY RECALL NOTICE" dated December 20, 2013 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to verify if the outer packaging of your on-hand inventory contains lot number 024522A; destroy any remaining inventory of the affected product in your possession and contact STERIS Customer Service at 1-800-548-4873 to obtain no cost replacement product and if you do not have the affected product in your inventory, no further action is required. If you have any questions regarding this matter, please contact your STERIS Account Manager or STERIS Customer Service at 1-800-548-4873.

    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