Recall Z-2276-2012
Advanced Sterilization Products · initiated June 1, 2012
Class II – products that might cause a temporary health problem or pose a slight threat of a serious nature
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.
Codes / lots: Product codes: 20390 (US).
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.
FDA-determined 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.
Details
- Recall number
- Z-2276-2012
- Initiated
- June 1, 2012
- Posted by FDA
- August 27, 2012
- Terminated
- September 11, 2013
- Product code
- MED – Sterilant, Medical Devices
- Quantity
- 1,310,844 units
- Distribution
- Nationwide (USA) and Puerto Rico.
- Recalling firm
- Advanced Sterilization Products, Irvine, CA