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.
This recall has been terminated (originally issued December 28, 2013).
- Company
- Steris Corporation
- Recall Initiated
- September 10, 2013
- Posted
- December 28, 2013
- Terminated
- February 14, 2014
- Recall Number
- Z-0605-2014
- Quantity
- 1,238 boxes
- Firm Location
- Mentor, OH
- Official Source
- View on FDA website ↗
Reason for Recall
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.
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, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and THE NETHERLANDS.
Lot / Code Info
Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.
Root Cause
Use error
Action Taken
On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.