CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA sol
FDA device recall Z-2276-2012 · posted 2012-08-27 · Terminated
Recall details
- Recalling firm
- Advanced Sterilization Products
- 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.
- 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.
- Root cause
- Process control
- Status
- Terminated
- Product code
- MED
- Quantity affected
- 1,310,844 units
- Distribution
- Nationwide (USA) and Puerto Rico.
- Date initiated
- 2012-06-01
- Date posted
- 2012-08-27
- Date terminated
- 2013-09-11
- Location
- Irvine, CA
Monitor recalls programmatically
Recalls and clearances share one API, with change alerts when new recalls post.
Related 510(k) clearances
| Record | Firm | Date |
|---|---|---|
| 0.55% ORTH-PHTHALALDEHYDE SOLUTION (K030004) | Advanced Sterilization Products | 2003-02-27 |