Advanced Sterilization Products Recalls STERRAD 200 Cassettes Due to Leak Indicator Defect
Advanced Sterilization Products is recalling STERRAD 200 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. The hazard involves a packaging indicator that may not function properly, which is a moderate risk of improper sterilization verification without reported injuries or fatalities.
Plain-English summary
Advanced Sterilization Products is recalling STERRAD 200 cassettes (Product Code 10118) because the leak indicator on the packaging may not function properly after exposure to hydrogen peroxide. 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.
A total of 19,978 units were distributed worldwide, with 9,792 units distributed in the United States. The recall is classified as Class II by the U.S. Food and Drug Administration.
Healthcare facilities and consumers should stop using the affected cassettes and contact Advanced Sterilization Products for further instructions or a replacement.
The recalled product
- Product
- STERRAD 200, Product Code 10118 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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