Advanced Sterilization Products Recalls Expired Tyvek Rolls with STERRAD Indicators
Advanced Sterilization Products is recalling Tyvek Rolls with STERRAD Chemical Indicators because they were shipped after their expiration date.
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 and involves a documentation/shipping error (expired product) without reported injuries or illnesses, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling Tyvek Rolls with STERRAD Chemical Indicators, Product Number 12425. The recall involves 2 units of Lot No. 68965-1241.
The product is being recalled because it was shipped to customers after its expiration date of May 18, 2013. The affected units were distributed to customers in Saudi Arabia and Portugal.
Consumers and healthcare facilities should stop using the recalled product and contact Advanced Sterilization Products for further instructions.
The recalled product
- Product
- Tyvek Pouch/Roll with STERRAD Chemical Indicator, P/N 12425
- Manufacturer
- Advanced Sterilization Products
- Affected units
- 2
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 (1)
- Lot No. 68965-1241
Distribution
Distribution scope not specified by the agency.
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