BEUDAMED
    FDA Recall 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 · Initiated February 5, 2015

    Recall

    Recall Number
    Z-1233-2015
    Event Number
    70436
    Firm
    Arrow International Inc
    FEI Number
    3015859709
    Product Code
    DSP
    Status
    Terminated
    Root Cause
    Labeling mix-ups
    Initiated
    February 5, 2015
    Posted
    March 2, 2015
    Terminated
    October 26, 2016
    Address
    2400 Bernville Road, Reading, PA, 19605

    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

    Action

    Arrow International notified Users, Distributors, Risk Managers by letter dated February 5, 2015. The letter explains the labeling error and requests immediately discontinue use and quarantine product. Customers were instructed to complete the Recall Acknowledgement Form and return by fax to 1-855-419-8507 whether they have or do not have the affected product. Customers with questions were instructed to contact their local sales representataive or Customers Service at 1-866-246-6990. For questions regarding this recall call 610-378-0131.

    Distribution

    Worldwide Distribution - USA (nationwide) and Internationally to Belgium

    Quantity

    165 units