Advanced Sterilization Products Recalls STERRAD NX Cassettes Due to Shelf-Life Data
Advanced Sterilization Products is recalling 12,280 STERRAD NX Cassettes because it lacks adequate data to support the product's labeled 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, but the source text does not report any illnesses, injuries, or hospitalizations. The hazard is related to insufficient data supporting the labeled shelf-life, which fits the criteria for a moderate severity score.
Plain-English summary
Advanced Sterilization Products is recalling 12,280 units of STERRAD NX System Cassettes, P/N 10133. The affected lots are 11J037, 11L038, and 11J033. These cassettes are used in conjunction with the STERRAD NX Sterilization system, a low-temperature general-purpose sterilizer for heat and moisture-sensitive reusable medical devices.
The recall was initiated because the manufacturer does not have adequate data to support the entire duration of the product's labeled shelf-life. The agency classifies this as a Class II recall.
The affected products were distributed nationwide in the United States and internationally to Argentina, Colombia, Taiwan, Slovenia, Australia, Mexico, Malaysia, Hungary, the Philippines, Belgium, France, Germany, Ireland, Italy, Spain, Norway, Switzerland, and the United Kingdom. Users should stop using the affected cassettes and contact Advanced Sterilization Products for further instructions.
The recalled product
- Product
- STERRAD NX Cassettes, P/N 10133. The STERRAD NX sterilizations systems are low-temperature general purpose sterilizers used to sterilize heat and moisture sensitive reusable medical devices. The sterilant used is hydrogen peroxide supplied in cassette form as a separate access
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 12,280
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Lot # 11J037
- 11L038
- 11J033
Distribution
Distributed nationwide across the United States.
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