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Field reports on stuff that let you down

FDA device recallMedications· Steris Corporation

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007

Official notice from a government agency or its published feed.

VERIFY Biological/Integrator Challenge Pack Model/Catalog Number: LCB007
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
Class IIA mid-level FDA recall: the product may cause temporary or reversible health problems. · Ongoing · Worldwide - US Nationwide distribution.

Hazard: 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…

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