Advanced Sterilization Products Recalls SteriTite Containers Due to Sterility Assurance Concerns
Advanced Sterilization Products is recalling SteriTite containers because data does not consistently show that the required sterility assurance level is achieved during testing.
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 III, which indicates the product is not likely to cause adverse health consequences. The issue is a lack of consistent data regarding sterility assurance, which is a quality control concern rather than a confirmed contamination event.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling specific SteriTite containers. These sealed container systems are used to package and protect surgical instruments for sterilization, transportation, storage, and aseptic presentation.
The recall was initiated because the company does not have consistent data to show that a sterility assurance level of 10(-6) is achieved during half-cycle test runs on new, unprocessed containers. This lack of consistent data raises concerns about the reliability of the sterilization process for the affected units.
A total of 267 units are involved in this recall, with 252 units distributed in the United States. The products were distributed nationwide in the US as well as in Australia, Vietnam, Thailand, Malaysia, China, South Korea, Mexico, Spain, Singapore, Hong Kong, and Portugal. Users of these containers should stop using the affected units and contact Advanced Sterilization Products for instructions on how to proceed.
The recalled product
- Product
- STERITITE Containers: STERITITE Container Kit, 1/4 size, 3" high, product code: 13902; STERITITE Mini Mid Size, 3" high, product code: 13903; STERITITE Container Kit, 1/2 size, 4" high, product code: 13904; STERITITE Container Kit, 3/4 size, 4" high, product code: 13905; STERITIT
- Manufacturer
- Advanced Sterilization Products
Distribution
Distributed nationwide across the United States.
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