Device 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.
Z-2276-2012
Product summary
- Event
- Event 62919
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,310,844 units
- Official record key
device-enforcement:Z-2276-2012
Official wording
Reason: The recall was initiated because Advanced Sterilization Products has discovered instances of missing labels on bottles of CIDEX OPA Solution, Part # 20390 manufactured between May 2011 and April 2012.
Code information: Product codes: 20390 (US).
Distribution pattern: Nationwide (USA) and Puerto Rico.
Derived failure modes
-
Labeling or packaging
missing labels