BEUDAMED
    FDA Enforcement Class II Terminated

    UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.

    Recall: Z-2698-2014 · Reported October 1, 2014

    Enforcement

    Recall Number
    Z-2698-2014
    Event ID
    68521
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Argon Medical Devices, Inc
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 1, 2014
    Initiation Date
    June 5, 2014
    Classification Date
    September 24, 2014
    Termination Date
    April 8, 2015
    Address
    1445 Flat Creek Rd, N/A, Athens, TX, 75751-5002, United States

    Description

    UltraStream Peel Away Kit; Model Numbers 32401524 (24 cm), 32401528 (28cm), 32401532 (32 cm), and 32401536 (36 cm) and 32402540 (40 cm) The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressure.

    Reason

    UltraStream Chronic Hemodialysis Catheter may develop cracks on the red (arterial) luer during attachment or manipulation.

    Code Info

    Lot Numbers: 11030816, 11031844, 11032797, 11033587, 11033816, 11034388, 11035767, 11038234, 11038335, 11039565, 11041289, 11041994, 11043179, 11044967, 11045825, 11048504, 11049437, 11049775, 11050202, 11051294, 11054323, 11055558, 11057594, 11059629, 11061076, 11063899, 11067036, 11025361, 11030817, 11031845, 11032798, 11033391, 11033945, 11034347, 11035769, 11036779, 11038235, 11038990, 11040156, 11041290, 11044061, 11045091, 11046609, 11047537, 11049868, 11050802, 11053027, 11053781, 11054547, 11054548, 11055303, 11056428, 11059470, 11062800, 11067037, 11030950, 11032799, 11033588, 11034388, 11035770, 11038236, 11039238, 11039865, 11041803, 11043180, 11046290, 11047538, 11049299, 11051665, 11055890, 11059471, 11035019, 11037137, 11041292, 11044061, 11056430, 11059473, 11031846, 11035968, 11038663, 11044540, 11046906, 11049669, 11054377, 11059472.

    Distribution

    Nationwide Distribution.

    Quantity

    3,783 units