Steris Corporation — Class II: VERIFY Biological Steam Test Pack Model/Catalog Number: S3065
Steris Corporation has initiated a Class II recall for the VERIFY Biological Steam Test Pack (Model S3065) because the Geobacillus stearothermophilus spore population may fall below the minimum shelf life specification. This defect could cause the indicator to show no growth despite an ineffective steam cycle, potentially leading to false-negative results.
This recall affects Steris Corporation, healthcare facilities utilizing steam sterilization monitoring systems, and personnel responsible for sterile processing and quality assurance.
The primary regulatory concern is the risk of false-negative results in sterilization monitoring, which could lead to the distribution and use of inadequately sterilized medical devices. For quality departments, this suggests a potential failure in stability testing or shelf-life validation protocols. Operations may face challenges in confirming the efficacy of past sterilization cycles where these specific test packs were used.
Verify current inventory for Model S3065 and quarantine affected lots according to manufacturer instructions. QA teams should evaluate if past sterilization records relied on these indicators and determine if a risk assessment for processed clinical items is necessary. Ensure that alternative validated biological indicators are available to prevent sterilization workflow interruptions.
Class II. Reason: Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no growth, indicating that the steam cycle was effective, even if the steam cycle did not achieve the intended spore reduction. Product: VERIFY Biological Steam Test Pack Model/Catalog Number: S3065. Firm: Steris Corporation (Mentor OH United States). Status: Ongoing.
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