BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    Recall: Z-1064-2013 · Reported April 17, 2013

    Enforcement

    Recall Number
    Z-1064-2013
    Event ID
    64527
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    April 17, 2013
    Initiation Date
    November 27, 2012
    Classification Date
    April 5, 2013
    Termination Date
    June 2, 2015
    Address
    2400 Bernville Road, Reading, PA, 19605, United States

    Description

    Arrow International FiberOptix Intra-Aortic Balloon Catheter Kit (IAB) 8 Fr 30 cc; Product Number: IAB-05830-LWS. The IAB is utilized for intra-aortic balloon counter-pulsation therapy.

    Reason

    Potential to have an internal leak at the fill port of the stainless steel tip, which may necessitate removal and replacement of the catheter.

    Code Info

    Lot Numbers: KF2073734 KS2083999 KF2083869 KF2083921

    Distribution

    Worldwide Distribution -- USA, Belgium, Great Britain, Italy, Kazakhstan, Latvia, Russia, Slovenia, Turkey, and South Africa.

    Quantity

    188 units