VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Inten...
FDA Recall #Z-0778-2023 — Class II — December 12, 2022
Product Description
VERIFY Dual Species Self-Contained Biological Indicators, 50 per box Item Number: S3060 Intended for use in installation testing and routine monitoring of steam and ethylene oxide sterilization processes
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.
Recalling Firm
Steris Corporation — Mentor, OH
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Devices
Product Quantity
338 boxes
Distribution
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Code Information
UDI: 10724995023833 lot #230613
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated
What Should You Do?
Stop using this medical device immediately and consult your healthcare provider. Contact the recalling firm for instructions on return or replacement. If you experienced an adverse event, inform your doctor.