Reported Sep 23, 2015 · Terminated
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
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 Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
- Lot codes and dates
1,128 of 1,128 codes
010713325010713325010713324010713326010713324020713327010713327010713327020713327090713339020713331090713339090713343090713343090713345100713347110713352120713353120713352100713347110713352120713353150713355150713356150713354160713360150713356150713354150713354170713361170713363170713362170713363170713361170713364180713368190713368190713369180713368190713369290713370290713370050813376050813377050813377050813378070813384060813379050813378070813384070813383070813383070813385120813391120813393070813385120813392120813393140813399140813400
- Amount recalled
- 318,632 cases
Why it was recalled
Advanced Sterilization Products (ASP) is reminding all CIDEX OPA Solution customers to follow the warnings and rinsing procedure in their current labelling around the criticality of proper rinsing of medical device following disinfection with CIDEX OPA according to the CIDEX OPA Solution IFU (Instruction For Use).
This product could cause temporary or reversible health problems — stop using it.
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