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).
FDA Recall Z-3045-2011 · Posted 2011-08-22
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Recalling FirmSteris Corporation
Recall StatusTerminated
Product CodeJOJ
Date Initiated2011-03-16
Date Terminated2013-03-19
Product Quantity2,500 (one per customer)
Reason for Recall
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.
Firm 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.
Root Cause
Labeling False and Misleading
Distribution Pattern
Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
Official Source
View FDA Recall →Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.
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