BEUDAMED
    FDA Enforcement Class II Terminated

    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

    Recall: Z-0486-2018 · Reported February 21, 2018

    Enforcement

    Recall Number
    Z-0486-2018
    Event ID
    78681
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Arrow International Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    February 21, 2018
    Initiation Date
    July 10, 2017
    Classification Date
    February 13, 2018
    Termination Date
    September 14, 2018
    Address
    2400 Bernville Rd, Reading, PA, 19605-9607, United States

    Description

    Radial Artery Catheterization Set, 1) NA-04550-1A & 2) NA-04550-X1A, device permits access to the peripheral arterial circulation or to other small vessels.

    Reason

    Needle supplier indicated the presence of loose polypropylene foreign matter above release specification.

    Code Info

    Lot Numbers: 1) 23F16H0859 & 2) 23F16J0547

    Distribution

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