Advanced Sterilization Products Recalls STERRAD 100S Cassettes for Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 100S cassettes because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide.
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. The hazard involves a packaging indicator that may not function properly, which is a functional defect but does not explicitly report hospitalizations or significant injuries, fitting the Moderate criteria for a Class II recall without severe reported harm.
Plain-English summary
Advanced Sterilization Products is recalling STERRAD 100S cassettes (Product Code 10113) due to a defect in the packaging. The leak indicator on the cassettes may not function properly after exposure to hydrogen peroxide.
The STERRAD Cassettes are used on the STERRAD Sterilization System, which is a low-temperature general-purpose sterilizer used to sterilize heat and moisture-sensitive reusable medical devices. 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, nor does it report any illnesses or injuries associated with this recall.
The recalled product
- Product
- STERRAD 100S, Product Code 10113. 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
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.
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