Recall Z-0605-2014
Steris Corporation · initiated September 10, 2013
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
Product
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.
Codes / lots: Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.
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.
FDA-determined cause: Use error
Action taken
On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.
Details
- Recall number
- Z-0605-2014
- Initiated
- September 10, 2013
- Posted by FDA
- December 28, 2013
- Terminated
- February 14, 2014
- Product code
- FRC – Indicator, Biological Sterilization Process
- 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, COLUMBIA, GERMANY, ITALY, MALAYSIA, PHILIPPINES, ROMANIA, SPAIN, and THE NETHERLANDS.
- Recalling firm
- Steris Corporation, Mentor, OH