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Alcon Research, Ltd. recalls CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Recalled June 15, 2016 · FDA recall Z-1940-2016 · Alcon Research
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. · FDA Class II
Units
156,712 units
Sold at
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
Description
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.
Product
CENTURION FMS (Fluidics Management System) Pack for the CENTURION Vision System and identified Custom Paks
Manufacturer(s)
Alcon Research, Ltd.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →