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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 Device Recall VERIFY Dual Species SelfContained Biological Indicator see related information
Date Initiated by Firm September 10, 2013
Date Posted December 28, 2013
Recall Status1 Terminated 3 on February 14, 2014
Recall Number Z-0605-2014
Recall Event ID 67036
510(K)Number K083665  K854902  K854631  
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 OH 44060-1834
For Additional Information Contact
440-392-7601
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		 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 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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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