Recall Z-3045-2011
Steris Corporation · initiated March 16, 2011
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).
Codes / lots: Model #: PCC005, PCC006, PCC007, PCC008, PCC031, PCC033, PCC034, PCC037 & PCC038,
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 taken
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.
Details
- Recall number
- Z-3045-2011
- Initiated
- March 16, 2011
- Posted by FDA
- August 22, 2011
- Terminated
- March 19, 2013
- Product code
- JOJ – Indicator, Physical/Chemical Sterilization Process
- Quantity
- 2,500 (one per customer)
- Distribution
- Worldwide Distribution - USA (nationwide) and the countries of Lebanon and Qatar.
- Recalling firm
- Steris Corporation, Mentor, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-3046-2011 | Verify SixCess Challenge Pack, Model #'s: LCC003, LCC005, LCC014 & LCC310, Mfr. By:…During an inspection the firm was notified that language contained in labeling and promotional literature… | 03/16/2011Terminated |