BEUDAMED
    FDA Enforcement Class II Terminated

    Thin-Flex Venous Cannula, Model Number:TF292902A

    Recall: Z-0398-2016 · Reported December 16, 2015

    Enforcement

    Recall Number
    Z-0398-2016
    Event ID
    72667
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Edwards Lifesciences, LLC
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    December 16, 2015
    Initiation Date
    November 4, 2015
    Classification Date
    December 9, 2015
    Termination Date
    February 10, 2017
    Address
    12050 Lone Peak Pkwy, N/A, Draper, UT, 84020-9414, United States

    Description

    Thin-Flex Venous Cannula, Model Number:TF292902A

    Reason

    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.

    Code Info

    Lot No: 59384061 59677936 59985533 59430941 59723695 59999044 59456603 59746454 60010418 59498228 59779239 60106398 59545464 59846864 60113045 59580433 59883622 60121142 59608030 59931290 60172116 59649580 59963196 60181079

    Distribution

    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.

    Quantity

    8,915 units