FDA-Device2022-05-18Class II
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Hazard
Bronchofiberscope Updated instructions on the use of certain chemicals to be used for reprocessing, conditions for ETO gas sterilization, rinsing steps after high-level disinfection, and a recommendation on using sterilization
Sold states
US Nationwide distribution.
Affected count
292 units
Manufactured in
3500 Corporate Pkwy, N/A, Center Valley, PA, United States
Products
BF-MP160F: EVIS EXERA Bronchofibervideoscope
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1048-2022Don't want to check this manually?
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