—#124585

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.

FDA product code: FRC — Indicator, Biological Sterilization Process
Device class: Class 2
Medical specialty: General Hospital
510(k) numbers: K083665, K854631, K854902
Affected lot / code info: Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.

Why it was recalled

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 (FDA determination)

Use error

Action the firm took

On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.

Recalling firm

Firm: Steris Corporation
Address: 5960 Heisley Rd, Mentor, Ohio 44060-1834

Distribution

Distribution pattern: 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.

Timeline

Recall initiated: 2013-09-10
Posted by FDA: 2013-12-28
Terminated: 2014-02-14
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #124585. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.