FDA-Device2012-10-10Class II
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.
Invuity, Inc.
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.
Sold states
Nationwide Distribution including AR, GA, SC, CA, OR, UT, and WA.
Affected count
197 devices
Manufactured in
39 Stillman St, N/A, San Francisco, CA, United States
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0007-2013Don't want to check this manually?
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