Advanced Sterilization Products Recalls STERRAD 100NX Cassettes Due to Packaging Data Gaps
Advanced Sterilization Products is recalling 1,923 STERRAD 100NX Cassettes because it lacks adequate data to support the packaging's leak indicator effectiveness for the full 15-month 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, and the source text does not report any illnesses, injuries, or hospitalizations. The hazard is a lack of data supporting packaging integrity, which fits the criteria for a moderate severity score involving low-risk contamination or voluntary precautionary measures without reported harm.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling 1,923 units of STERRAD 100NX Cassettes, Product Code 10144. The STERRAD Sterilization System is a low-temperature general-purpose sterilizer used to sterilize heat and moisture-sensitive reusable medical devices.
The recall was initiated because ASP does not have adequate data to support the effectiveness of the packaging's leak indicator for the entire duration of the STERRAD 100 NX System cassette's 15-month shelf life. The affected cassettes were distributed nationwide in the United States and internationally to numerous countries, including Russia, Venezuela, Kuwait, Saudi Arabia, Hungary, the United Kingdom, Italy, and others.
Healthcare facilities and users of the STERRAD system should check their inventory for the specific lot numbers listed in the recall notice. If the cassettes are found, they should be removed from service and returned to Advanced Sterilization Products or their authorized distributor for replacement or refund, per the company's instructions.
The recalled product
- Product
- STERRAD 100NX Cassettes, Product Code: 10144 The STERRAD Sterilization System is a low temperature general purpose sterilizer used to sterilize heat and moisture sensitive reusable medical devices.
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 1,923
Distribution
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