Advanced Sterilization Products Recalls STERRAD System Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD System 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 quality control issue without reported injuries or illnesses, fitting the criteria for a moderate severity recall.
Plain-English summary
Advanced Sterilization Products is recalling STERRAD System cassettes, Product Code 10133. The STERRAD Cassettes are used on the STERRAD Sterilization System, a low-temperature general-purpose sterilizer used to sterilize heat and moisture-sensitive reusable medical devices.
The recall is being issued because the leak indicator on the STERRAD System cassettes packaging may not function properly after exposure to hydrogen peroxide. A total of 19,978 units were distributed worldwide, with 9,792 units distributed in the United States.
Healthcare facilities and users of the STERRAD Sterilization System should check their inventory for affected cassettes. The source text does not specify specific consumer actions or contact information for the recall.
The recalled product
- Product
- STERRAD NX, Product Code 10133 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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