Class 2 Device Recall Steris VERIFY Steam Test Pack

• Date Initiated by Firm: December 12, 2022
• Date Posted: January 03, 2023
• Recall Status: Open, Classified
• Recall Number: Z-0780-2023
• Recall Event ID: 91315
• 510(K)Number: K083665
• Product Classification: Indicator, biological sterilization process - Product Code FRC
• Product: VERIFY Steam Test Pack (20 Tests and 5 controls) Item Number: S3065 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
• Code Information: UDI: 10724995023840 lot #230613
• FEI Number: 1527821
• 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: 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: 60 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