Advanced Sterilization Products Recalls STERRAD CYCLESURE 24 Biological Indicators
Advanced Sterilization Products is recalling STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the entire labeled shelf-life.
The agency’s classification
FDA (Devices): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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 data deficiency regarding shelf-life, which fits the criteria for a moderate, precautionary recall.
Plain-English summary
Advanced Sterilization Products is recalling certain lots of STERRAD CYCLESURE 24 Biological Indicators. The recall is being conducted because the company may not have adequate data to support the entire duration of the labeled shelf-life for the product.
The STERRAD CYCLESURE 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. The recall involves 69,994 cases distributed worldwide, including nationwide distribution across the United States and in various international countries.
Consumers and healthcare facilities should check their inventory for the specific lot codes listed in the recall notice. If the product is found, it should be stopped from use and returned to the manufacturer or distributor for further instructions.
The recalled product
- Product
- STERRAD CYCLESURE 24 Biological Indicator (BI) The STERRAD CYCLESURE 24 Biological Indicator (BI), is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 69,994
Distribution
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