FDA-Device2023-01-11Class II
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
Steris Corporation
Hazard
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.
Sold states
Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA
Affected count
338 boxes
Manufactured in
5960 Heisley Rd, N/A, Mentor, OH, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0778-2023Don't want to check this manually?
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