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.
This recall has been terminated (originally issued August 27, 2012).
- Company
- Advanced Sterilization Products
- Recall Initiated
- June 1, 2012
- Posted
- August 27, 2012
- Terminated
- September 11, 2013
- Recall Number
- Z-2276-2012
- Quantity
- 1,310,844 units
- Firm Location
- Irvine, CA
- Official Source
- View on FDA website ↗
Reason for Recall
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.
Distribution
Nationwide (USA) and Puerto Rico.
Lot / Code Info
Product codes: 20390 (US).
Root Cause
Process control
Action Taken
An "Urgent Medical Device Recall" letter dated August 10, 2012 was sent to all customers who purchased the CIDEX OPA solution, part #20390 (manufactured between May 2011 and April 2012). The letter informed the customers of the problem identified and the actions to be taken. Customers were instructed to notify their customers if they have distributed bottles of CIDEX OPA Solution to other locations. Customers were instructed to call Stericycle at (866) 629-6182 to arrange for return of the product.