Recall Z-0605-2014 ยท FRC Indicator, Biological Sterilization Process
Steris Corporation
VERIFY Dual Species Self-Contained Biological Indicator, Distributed by STERIS Corporation, Mentor, OH. Intended for use in installation testing and routine monitoring of steam sterilization and ethylene oxide sterilization processes.
| Date | Dec 28, 2013 (initiated Sep 10, 2013) |
| Status | Terminated |
| Reason | STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a result the spore count on the affected product is lower than the labeled minimum and the product may incorrectly indicate that a 5-log spore kill was achieved. |
| Root cause | Use error |
| Action | On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers. |
| Quantity | 1,238 boxes |
| Distribution | Worldwide Distribution-USA (nationwide) including the states of AK, Al, AR, AZ, CA, CO, DE, FL, GA, HI, IA, ID, IL, IN, KS, KY, LA, MA, MD, ME, MI, MN, MO, MS, MT, NC, ND, NE, NH, NJ, NM, NV, NY, OH, OK, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV and WY, and the countries of BAHRAIN, CANADA, COLUMBI |
| FDA record | Open on fda.gov |