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U.S. Department of Health and Human Services

Class 2 Device Recall VERIFY Dual Species SelfContained Biological Indicator

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 Class 2 Recall
VERIFY Dual Species SelfContained Biological Indicator
see related information
Date Posted December 28, 2013
Recall Status1 Terminated on February 14, 2014
Recall Number Z-0605-2014
Recall Event ID 67036
Premarket Notification
510(K) Numbers
K083665  K854631  K854902 
Product Classification Indicator, Biological Sterilization Process - Product Code FRC
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.
Code Information Lot #131004 Model #'s: S3060, S3061, S3065, S3069, LCB006 & LCB007.
Recalling Firm/
Manufacturer
Steris Corporation
5960 Heisley Rd
Mentor, Ohio 44060-1834
Manufacturer 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 2
TRAINING: Use Error
Action On September 10, 2013, the firm sent Urgent Voluntary Recall Notices to their customers.
Quantity in Commerce 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.
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = STERIS Corporation
510(K)s with Product Code = FRC and Original Applicant = SURGICOT, INC.
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