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U.S. Department of Health and Human Services

Class 2 Device Recall Steris VERIFY Dual Species Self Contained Biological Indicator

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  Class 2 Device Recall Steris VERIFY Dual Species Self Contained Biological Indicator see related information
Date Initiated by Firm December 12, 2022
Date Posted January 03, 2023
Recall Status1 Open3, Classified
Recall Number Z-0779-2023
Recall Event ID 91315
510(K)Number K083665  
Product Classification Indicator, biological sterilization process - Product Code FRC
Product VERIFY Dual Species Self-Contained Biological Indicators, 100 per box
Item Number: S3061

Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
Code Information UDI: 10724995023833, 50724995023824 lot #230613
Recalling Firm/
Manufacturer		 Steris Corporation
5960 Heisley Rd
Mentor OH 44060-1834
For Additional Information Contact SAME
440-392-7601
Manufacturer Reason
for Recall		 Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to monitor steam and ethylene oxide sterilization cycles, the potential hazard is that the BI will show no growth indicating that the cycle was effective, even if it may not have been.
FDA Determined
Cause 2		 Employee error
Action Steris issued Urgent Medical Device Recall letters to Customers and Distributors on 12/12/2022 via FedEX. Letter states reason for recall, health risk and action to take: 1. Please immediately inspect your on-hand inventory for product affected by this recall. 2. Please complete the Medical Device Recall Response Form included with this letter and destroy any remaining product in your inventory. STERIS will coordinate shipment of replacement product upon receipt of the completed Recall Response Form. 3. Return the completed Recall Response Form via email to: Regulatory_Compliance@STERIS.com or via fax to (440) 392-8963. If you have questions regarding this recall, please contact Melissa Gonsalves, Senior Product Manager at (440) 392-7043, or STERIS Customer Service at 1-800-548-4873.
Quantity in Commerce 857 boxes
Distribution Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
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 The manufacturer has initiated the recall and not all products have been corrected or removed. This record will be updated as the status changes.
510(K) Database 510(K)s with Product Code = FRC and Original Applicant = STERIS Corporation
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