Edwards Lifesciences, LLC recalls Thin-Flex Venous Cannula, Model Number:TF292902A

Recall date

November 4, 2015

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

Z-0398-2016

FDA classification

Class II

Brand / firm

Edwards Lifesciences, LLC

Sold / distributed

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.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Thin-Flex Venous Cannula, Model Number:TF292902A