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U.S. Department of Health and Human Services

Class 2 Device Recall Verify SixCess Challenge Pack

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  Class 2 Device Recall Verify SixCess Challenge Pack see related information
Date Initiated by Firm March 16, 2011
Date Posted August 22, 2011
Recall Status1 Terminated 3 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. 275¿F 3 minute Prevacuum Cycle).
Code Information Model #'s: LCC003, LCC005, LCC014 & LCC310.
Recalling Firm/
Steris Corporation
5960 Heisley Rd
Mentor OH 44060
For Additional Information Contact Heide Ames
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 2
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.