Recall Z-0779-2023 ยท FRC Indicator, Biological Sterilization Process
Steris Corporation
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
| Date | Jan 3, 2023 (initiated Dec 12, 2022) |
| Status | Open, Classified |
| Reason | 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. |
| Root 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 o |
| Quantity | 857 boxes |
| Distribution | Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K083665 | VERIFY SCBI 275F 3-10 STERIS Corporation, Sep 1, 2009 |