BEUDAMED
    FDA Enforcement Class II Terminated

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    Recall: Z-1259-2015 · Reported March 18, 2015

    Enforcement

    Recall Number
    Z-1259-2015
    Event ID
    70603
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    March 18, 2015
    Initiation Date
    November 8, 2013
    Classification Date
    March 10, 2015
    Termination Date
    March 16, 2015
    Address
    2400 Bernville Rd, N/A, Reading, PA, 19605-9607, United States

    Description

    Arrow Intra-Aortic Balloon Catheter Kit Fiberoptix (IAB), 8 Fr 40 cc Model: IAB-05840-LWS

    Reason

    Potential for a leak between the catheter and the bifurcate which would allow helium to escape to the atmosphere.

    Code Info

    Lot Number: KF1111796 Exp. Date: 11/30/2013

    Distribution

    Distribution US nationwide (including AZ, NJ, ME, TX, WA), and Germany.

    Quantity

    166 units