Reported Sep 5, 2012 · Terminated

CIDEX OPA, High Level Disinfectant Solution, Glutaraldehyde-free (0.55% ortho-phthaladehyde) solution. The CIDEX OPA…

Advanced Sterilization Products

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Advanced Sterilization Products · 33 Technology Dr · Irvine, CA · 92618-2346

Is this the product you have?

  • 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.
Lot codes and dates
  • Product codes20390 (US)
Amount recalled
1,310,844 units

Where it was sold

  • Nationwide
  • PR

Why it was recalled

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.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA device enforcement) notice

Notice updated Sep 11, 2013 · Data as of Sep 19, 5:24 PM UTC

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