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Recall Observatory FDA recall evidence

Device product

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

Z-0778-2023

December 12, 2022

Class II

Product summary

Firm
Steris Corporation
Event
Event 91315
Status
Ongoing
Classification
Class II
Quantity
338 boxes
Official record key
device-enforcement:Z-0778-2023

Official wording

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.

Code information: UDI: 10724995023833 lot #230613

Distribution pattern: Nationwide Foreign: AE AT CA CO ES FI GU IN IT JP MX SG TH TW ZA

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    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.