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FDAAugust 10, 2015device

CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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).

What to do

FDA enforcement status: Terminated

Brands named

advanced sterilization productsadvancedadvanced sterilization

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices. — Recall Details · AllClear