Recall Z-3045-2011 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Steris Corporation
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 pro
| Date | Aug 22, 2011 (initiated Mar 16, 2011) |
| Status | Terminated |
| 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. |
| Root 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 | 2,500 (one per customer) |
| Distribution | Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.