Advanced Sterilization Products Recalls STERRAD Biological Indicators Due to Shelf-Life Data Gaps
Advanced Sterilization Products is recalling specific lots of STERRAD CYCLESURE 24 Biological Indicators because the company lacks adequate data to support the product's 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 hospitalizations, injuries, or illnesses. The hazard is related to data support for shelf-life rather than an active contamination or structural defect, fitting the criteria for a moderate severity precautionary recall.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling certain lots of the STERRAD CYCLESURE 24 Biological Indicator (BI) product. The recall is being conducted because the company does not have adequate data to support the entire duration of the product's labeled shelf-life.
The affected product is intended to be used as a standard method for frequent monitoring of the STERRAD Sterilization System cycles. The recall covers 38,693 units distributed nationwide in the United States. Specific lot numbers are listed in the agency's recall record.
The source text does not provide specific instructions for consumers or healthcare facilities on how to handle the recalled units, nor does it report any illnesses or injuries associated with the product.
The recalled product
- 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 monitorin
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 38,693
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- Lot# 002127
- 003127
- 005127
- 006127
- 007127
- 008127
- 009127
- 010127
- 011128
- 012127
- 013127
- 014127
- 015127
- 016127
- 018127
- 019127
- 020127
- 021127
- 023127
- 024127
Distribution
Distributed nationwide across the United States.
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