Recall Z-1166-2014 ยท JOJ Indicator, Physical/Chemical Sterilization Process
Steris Corporation
VERIFY SixCess 270FP Challenge Pack, STERIS Corporation, 5960 Heisley Road, Mentor, OH 44060, 440-354-2600. The VERIFY SixCess 270FP Challenge Pack is used to monitor steam sterilization loads processed at 270F using typical healthcare dynamic air removal steam sterilization cycles.
| Date | Mar 10, 2014 (initiated Dec 19, 2013) |
| Status | Terminated |
| Reason | STERIS has identified that the outer shipping package for one lot (Lot #024552A) of VERIFY SixCess Challenge Packs incorrectly identifies the lot as Lot #024522A. |
| Root cause | Labeling False and Misleading |
| Action | The firm, Steris, sent an "URGENT VOLUNTARY RECALL NOTICE" dated December 20, 2013 to their customers. The letter describes the product, problem and actions to be taken. The customers were instructed to verify if the outer packaging of your on-hand inventory contains lot number 024522A; destroy any remaining inventory of the affected product in your possession and contact STERIS Customer Service at 1-800-548-4873 to obtain no cost replacement product and if you do not have the affected product in your inventory, no further action is required. If you have any questions regarding this matter, |
| Quantity | 94 boxes/20 units |
| Distribution | Worldwide Distribution: US (nationwide) including states of: IL, LA, ME, MI, NC, OH, OK, VA, WI & WV; and to the country of: Canada. Product was also shipped to Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K103053 | VERIFY 270FP CHALLENGE PACK STERIS Corporation, Mar 10, 2011 |