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Advanced Sterilization Products recalls STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation
Recalled August 8, 2012 · FDA recall Z-2100-2012 · Advanced Sterilization Products
Hazard
Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life. · FDA Class II
Units
38,693 units
Sold at
Worldwide Distribution - USA (nationwide)
Description
Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product because it does not have adequate data to support the entire duration of the product's labeled shelf-life.
Product
STERRAD Cyclesure Biological Indicator (BI), P/N 14324 are sold in cases, packaged as part of STERRAD System Validation kits and STERRAD test packs. The STERRAD CYCLESURE 24 Biological Indicator (BI), P/N 14324 is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
Manufacturer(s)
Advanced Sterilization Products
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →