Recall Z-0780-2023
Steris Corporation · initiated December 12, 2022
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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
Codes / lots: UDI: 10724995023840 lot #230613
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 taken
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.
Details
- Recall number
- Z-0780-2023
- Initiated
- December 12, 2022
- Posted by FDA
- January 3, 2023
- Product code
- FRC – Indicator, Biological Sterilization Process
- Quantity
- 60 boxes
- Distribution
- Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
- Recalling firm
- Steris Corporation, Mentor, OH
Other products in the same recall event
| Recall | Product | Initiated |
|---|---|---|
| Z-0778-2023 Class II | VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060…Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was… | 12/12/2022Open, Classified |
| Z-0779-2023 Class II | VERIFY Dual Species Self-Contained Biological Indicators, 100 per box Item Number: S3061…Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was… | 12/12/2022Open, Classified |
| Z-0781-2023 Class II | VERIFY Steam Test Pack (20 Tests and 20 controls) Item Number: S3069 Intended for use in…Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was… | 12/12/2022Open, Classified |