Advanced Sterilization Products Recalls CIDEX OPA Solution Due to Missing Labels
Advanced Sterilization Products is recalling CIDEX OPA Solution bottles manufactured between May 2011 and April 2012 because some are missing labels.
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 1/5 (Low).
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: The recall is due to missing labels, which is a documentation and packaging issue. No injuries, illnesses, or functional defects are reported in the source text.
Plain-English summary
Advanced Sterilization Products is recalling 1,310,844 units of CIDEX OPA, High Level Disinfectant Solution, Part # 20390. The affected units were manufactured between May 2011 and April 2012 and were distributed nationwide in the United States and Puerto Rico.
The recall was initiated because the company discovered instances of missing labels on the bottles. The product is intended for automated and manual cleaning and disinfection.
Consumers and healthcare facilities should stop using the affected product and contact Advanced Sterilization Products for further instructions.
The recalled product
- Product
- CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA solution is intended for automated and manual cleaning and disinfection.
- Manufacturer
- Advanced Sterilization Products
- Hazard
- Affected units
- 1,310,844
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)
- Product codes: 20390 (US).
Distribution
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