—#103395

Product

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 product code: JOJ — Indicator, Physical/Chemical Sterilization Process
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038,

Why it was recalled

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.

Root cause (FDA determination)

Labeling False and Misleading

Action the firm took

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.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060

Distribution

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

Timeline

Recall initiated: 2011-03-16
Posted by FDA: 2011-08-22
Terminated: 2013-03-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #103395. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.