Class 2 Device Recall Verify SixCess Challenge Pack

• Date Initiated by Firm: March 16, 2011
• Date Posted: August 22, 2011
• Recall Status: Terminated on March 19, 2013
• Recall Number: Z-3046-2011
• Recall Event ID: 59713
• Product Classification: Indicator, physical/chemical sterilization process - Product Code JOJ
• Product: Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By: Albert Browne, LTD, Chancery House 190 Waterside Rd. Hamilton Industrial Park, Leicester, Leicester, LE5QZ, United Kingdom. Verify SixCess Challenge Packs are used to confirm that that critical parameters of steam sterilization have been reached within a challenging test pack design. Each challenge pack is also specific to a sterilization temperature and type (i.e. 275F 3 minute Prevacuum Cycle).
• Code Information: Model #'s: LCC003, LCC005, LCC014 & LCC310.
• Recalling Firm/ Manufacturer: Steris Corporation; 5960 Heisley Rd; Mentor OH 44060
• For Additional Information Contact: Heide Ames; 440-392-7421
• Manufacturer 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.
• FDA Determined Cause: Labeling False and Misleading
• 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.
• Quantity in Commerce: 2,500
• Distribution: Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
• Total Product Life Cycle: TPLC Device Report

¹ A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
² Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
³ For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.