Advanced Sterilization Products Recalls STERRAD Cyclesure Biological Indicators
Advanced Sterilization Products is recalling STERRAD Cyclesure Biological Indicators due to a microscopic flaw in the outer vial.
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 describes the defect as 'microscopic intermittent and low frequency' with no reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling the STERRAD Cyclesure Biological Indicator (BI, Part No. 14324). This product is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles.
The recall was initiated because ASP identified a microscopic intermittent and low frequency flaw in the outer vial of the STERRAD Cyclesure 24 Biological Indicator. The recall involves 4,048 units total, with 4,014 units distributed in the US and the remainder distributed worldwide. The affected units are identified by specific batch/lot numbers listed in the agency's structured data.
Consumers and healthcare facilities should stop using the affected biological indicators and contact Advanced Sterilization Products for further instructions on the recall.
The recalled product
- Product
- 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.
- Manufacturer
- Advanced Sterilization Products
- Hazard
Distribution
Distribution scope not specified by the agency.
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