Advanced Sterilization Products recalls CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
- Recall date
- August 10, 2015
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Recall number
- Z-2774-2015
- FDA classification
- Class II
- Brand / firm
- Advanced Sterilization Products
- Sold / distributed
- US
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).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.
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