BEUDAMED
    FDA Enforcement Class II Terminated

    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle

    Recall: Z-1233-2015 · Reported March 11, 2015

    Enforcement

    Recall Number
    Z-1233-2015
    Event ID
    70436
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 11, 2015
    Initiation Date
    February 5, 2015
    Classification Date
    March 2, 2015
    Termination Date
    October 26, 2016
    Address
    2400 Bernville Road, N/A, Reading, PA, 19605, United States

    Description

    ARROW FiberOptix Intra-Aortic Balloon Catheter Kit, 40 cc 7.5 Fr Product Code: IAB-05840-LWS The Arrow IAB is utilized for intra-aortic balloon counter-pulsation therapy in the aorta, whereby balloon inflation, during diastole and deflation, during systole increases blood supply to the heart muscle and decreases work of the left ventricle

    Reason

    Outer package product label incorrectly identifies the product as FiberOptix Flex IAB 7.5Fr rather than the correct FiberOptix IAB 8Fr

    Code Info

    Lot Number: 18F14M0001

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Belgium

    Quantity

    165 units