Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 100NX cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
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, and the hazard involves a packaging indicator defect without reported injuries or illnesses, fitting the criteria for a moderate severity rating.
Plain-English summary
Advanced Sterilization Products is recalling STERRAD 100NX cassettes, identified by Product Code 10144. These cassettes are used in the STERRAD Sterilization System, a low-temperature general-purpose sterilizer designed for heat- and moisture-sensitive reusable medical devices.
The recall was initiated because the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. This defect could compromise the integrity of the packaging's ability to indicate a leak.
A total of 19,978 units were distributed worldwide, with 9,792 units distributed in the United States. The source text does not specify specific actions for consumers or healthcare facilities beyond the recall notice itself.
The recalled product
- Product
- STERRAD 100NX, Product Code 10144 The STERRAD Cassettes are used on STERRAD Sterilization System which is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Manufacturer
- Advanced Sterilization Products
- Hazard
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 5 recalled by Advanced Sterilization Products under a single FDA (Devices) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 5 products in this recall →Related recalls
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Similar recalls
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