FDA-Device2015-12-16Class II
Thin-Flex Venous Cannula, Model Number:TF292902A
Edwards Lifesciences, LLC
Hazard
Edwards Lifesciences initiated a field action for the Thin-Flex Venous Cannula (Model TF292902A) because the connector size is incorrectly described in the Edwards product guide as 3/8 inch. The actual and correct connector size is 1/2 inch.
Sold states
Worldwide Distribution - USA (nationwide) Distribution and to the countries of : United Arab Emirates , Belgium, Czech Republic, Spain, France, United Kingdom, Italy, Kuwait, Netherlands, Romania, Saudi Arabia, Sweden, Singapore, Thailand and South Africa.
Affected count
8,915 units
Manufactured in
12050 Lone Peak Pkwy, N/A, Draper, UT, United States
Products
Thin-Flex Venous Cannula, Model Number:TF292902A
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=Z-0398-2016Don't want to check this manually?
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