Recall Z-2276-2012 ยท MED Sterilant, Medical Devices
Advanced Sterilization Products
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.
| Date | Aug 27, 2012 (initiated Jun 1, 2012) |
| Status | Terminated |
| 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. |
| Root cause | Process control |
| Action | 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. |
| Quantity | 1,310,844 units |
| Distribution | Nationwide (USA) and Puerto Rico. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
| K030004 | 0.55% ORTH-PHTHALALDEHYDE SOLUTION Advanced Sterilization Products, Feb 27, 2003 |