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.
Recall
- Recall Number
- Z-2276-2012
- Event Number
- 62919
- Firm
- Advanced Sterilization Products
- FEI Number
- 3003662624
- Product Code
- MED
- Status
- Terminated
- Root Cause
- Process control
- Initiated
- June 1, 2012
- Posted
- August 27, 2012
- Terminated
- September 11, 2013
- Address
- 33 Technology Dr, Irvine, CA, 92618-2346
Description
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.
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.
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.
Nationwide (USA) and Puerto Rico.
1,310,844 units