Advanced Sterilization Products Recalls Sterrad Cyclesure 24 Biological Indicators
Advanced Sterilization Products is recalling Sterrad Cyclesure 24 Biological Indicators because the manufacturer lacks adequate data to support the full labeled shelf-life.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a lack of data supporting shelf-life, which fits the criteria for a moderate severity recall involving potential quality issues without confirmed harm.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling all lots of Sterrad Cyclesure 24 Biological Indicator (BI) products manufactured between February 2008 and December 2011. The recall is being conducted because the manufacturer may not have adequate data to support the entire duration of the labeled shelf-life for these items.
The affected products include the Sterrad Cyclesure 24 Biological Indicator (P/N 14324) and various validation kits containing these indicators. The recall covers 38,532 units distributed nationwide in the United States and in numerous countries worldwide, including Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Colombia, Ecuador, Guatemala, Hong Kong, Indonesia, India, Japan, South Korea, Mexico, Malaysia, Panama, Peru, Philippines, Singapore, Thailand, Venezuela, and Russia.
The U.S. Food and Drug Administration has classified this as a Class II recall. Consumers and healthcare facilities should stop using the affected biological indicators and contact Advanced Sterilization Products for further instructions or replacement.
The recalled product
- Product
- STERRAD CYCLESURE 24 Biological Indicator (BI) product, P/N 14324. Validation kits with Sterrad Cyclesure 24 BI products: Codes/Serial Numbers, Product Description: 14324 Sterrad Cyclesure 24 Biological Indicator. 14324-02 Sterrad Cyclesure 24 Biological Indicator. 10
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 38,532
Distribution
Distributed nationwide across the United States.
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