Advanced Sterilization Products Recalls STERRAD 100NX Wall Charts for Incorrect Instructions
Advanced Sterilization Products is recalling 1,465 STERRAD 100NX wall charts because they contain incorrect instructions regarding instrument tray wrapping.
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: This is a Class II recall involving a labeling error that could lead to improper sterilization practices, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Advanced Sterilization Products (ASP) is recalling 1,465 units of the Wall Chart for the STERRAD 100NX System, product number 10104. The STERRAD 100NX Sterilizer is designed for the sterilization of both metal and nonmetal medical devices at low temperatures.
The recall was initiated because the wall charts incorrectly state that "APTIMAX Instrument Trays can be enclosed in either polypropylene wrap or in Tyvek Pouches with STERRAD Chemical Indicators." This mislabeling could lead to improper use of the sterilization system.
The affected wall charts were distributed nationwide. Users should check their wall charts for the specific product number and lot codes listed in the official recall notice. If a chart is affected, it should be removed from use and replaced according to the manufacturer's instructions.
The recalled product
- Product
- Wall Chart for STERRAD 100NX System, P/N 10104. The STERRAD 100NX Sterilizer is designed for sterilization of both metal and nonmetal medical devices at low temperatures.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 1,465
Distribution
Distributed nationwide across the United States.
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