FDA-Device2014-01-08Class II
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Advanced Sterilization Products
Hazard
Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI) because ASP has identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator.
Sold states
Worldwide Distribution.
Affected count
4048 units total (4014 units in US)
Manufactured in
33 Technology Dr, Irvine, CA, United States
Products
STERRAD Cyclesure Biological Indicator (BI, Part No. 14324. Intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0604-2014Don't want to check this manually?
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