Recall Z-2276-2012— Advanced Sterilization Products
Class II · Terminated
Class II FDA medical device recall by Advanced Sterilization Products, initiated 2012-06-01, terminated 2013-09-11. It names one FDA 510(k) clearance: K030004. 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.. 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..
- Recalling firm
- Advanced Sterilization Products
- Classification
- Class II
- Status
- Terminated
- Initiated
- 2012-06-01
- Terminated
- 2013-09-11
- Firm location
- Irvine, CA, United States
510(k) clearances named in this recall
1 on FDA's recordK-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.
Product 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.
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.
Data sourced from openFDA. This site is unofficial and independent of the FDA.