FDA-Device2015-09-23Class II

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

Advanced Sterilization Products
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).

Sold states
US
Affected count
318,632 cases
Manufactured in
33 Technology Dr, Irvine, CA, United States
Products
CIDEX OPA Solution, P/N 20390 for use as a high level disinfectant for reprocessing heat sensitive medical devices.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-2774-2015

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