BEUDAMED
    FDA Recall Terminated

    Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250F 30 minute Gravity Cycle).

    Recall: Z-3045-2011 · Initiated March 16, 2011

    Recall

    Recall Number
    Z-3045-2011
    Event Number
    59713
    Firm
    Steris Corporation
    FEI Number
    1527821
    Product Code
    JOJ
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    March 16, 2011
    Posted
    August 22, 2011
    Terminated
    March 19, 2013
    Address
    5960 Heisley Rd, Mentor, OH, 44060

    Description

    Verify SixCess Indicator Strips, Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Indicator Strips are used to confirm that the parameters of sterilization have been reached within packs, pouches and wrapped items processed through a steam sterilization process. Each indicator strip is specific to a sterilization temperature and type (i.e. 250F 30 minute Gravity Cycle).

    Reason

    During an inspection the firm was notified that language contained in labeling and promotional literature directs Customers that the products can be used to replace biological indicators and/or release loads containing implants.

    Action

    STERIS sent a Customer Notification letter dated March 16, 2010, to all affected customers. The letter identified the product, the problem, and the action to be taken by the customer. Customers were instructed to review and follow the Challenge Packs' revised instructions for use enclosed as Attachment A (270-4) and Attachment B (275F 3). For any questions regarding this recall customers were instructed to contact their STERIS Account Manager or call 440-392-7421.

    Distribution

    Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.

    Quantity

    2,500 (one per customer)