| Class 2 Device Recall VERIFY Dual Species SelfContained Biological Indicator | |
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 K854631 K854902 |
Product Classification |
Indicator, biological sterilization process - Product Code FRC
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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
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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 |
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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.
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510(K) Database | 510(K)s with Product Code = FRC 510(K)s with Product Code = FRC
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