FDA-Device2016-06-15Class II
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Alcon Research, Ltd.
Hazard
Alcon is conducting this Voluntary Medical Device Removal for specific lots of its CENTURION FMS packs due to the possible presence of a molding irregularity found within the aspiration luer which may result in a reduction of vacuum within the aspiration line.
Sold states
US, Argentina, Australia, Austria, Belarus, Belgium, Brazil, Bulgaria, Canada, Chile, China, Colunbia, Croatia, Cyprus, Czech Republic, Denmark, Finland, Germany, Greece, Hong Kong, Hungary, India, Ireland, Italy, Japan, Korea, Malaysia, Mexico, Morocco, Netherlands, New Zealand, Norway, Peru, Philippines, Poland, Portugal, Russia, Slovakia, Spain, Sweden, Switzerland, Taiwan, Thailand, Turkey, United Kingdom, Uruguay
Affected count
156,712 units
Manufactured in
6201 South Fwy, N/A, Fort Worth, TX, United States
Products
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-1940-2016Don't want to check this manually?
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