Medical device recalls Moderate risk

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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