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Invuity, Inc. recalls BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterili
Recalled October 10, 2012 · FDA recall Z-0007-2013 · Invuity
Hazard
Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time. · FDA Class II
Units
197 devices
Sold at
Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.
Description
Invuity is notifying customers to return all obsolete BriteField Illuminated Suction Devices from the field. It has not been distributed since March 2011 as the next generation product was introduced at that time.
Product
BriteField illuminated Suction Device; Model numbers 8Fr, 10Fr and 12Fr, Kit (included 8Fr, 10Fr and 12Fr and a sterilization tray. The Invuity Brite Field Illuminated Suction Device is intended to aspirate from the surgical site and to provide illumination from a high intensity light source.
Manufacturer(s)
Invuity, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →