Advanced Sterilization Products Recalls CIDEX OPA Solution for Rinsing Labeling
Advanced Sterilization Products is reminding customers to follow rinsing instructions for CIDEX OPA Solution to ensure proper disinfection of medical devices.
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, but the source text describes it as a reminder to follow existing labeling and rinsing procedures without reporting any illnesses, injuries, or specific defects, fitting the criteria for a moderate, precautionary action.
Plain-English summary
Advanced Sterilization Products (ASP) is issuing a recall notice for CIDEX OPA Solution, a high-level disinfectant used for reprocessing heat-sensitive medical devices. The recall involves 318,632 cases of the product, identified by P/N 20390, which were distributed in the United States.
The action is a reminder for all customers to strictly follow the warnings and rinsing procedures detailed in the current labeling and Instruction For Use (IFU). The company emphasizes the criticality of proper rinsing of medical devices following disinfection with CIDEX OPA to ensure the product functions as intended.
Customers are advised to review the current labeling and IFU for CIDEX OPA Solution to ensure they are adhering to the required rinsing steps. No specific illnesses or injuries have been reported in the source text.
The recalled product
- Product
- CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
- Manufacturer
- Advanced Sterilization Products
- Category
- Medical Device — Disinfectant
- Affected units
- 318,632
Distribution
Distribution scope not specified by the agency.
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