BEUDAMED
    FDA Recall Terminated

    UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.

    Recall: Z-2697-2014 · Initiated June 5, 2014

    Recall

    Recall Number
    Z-2697-2014
    Event Number
    68521
    Firm
    Argon Medical Devices, Inc
    FEI Number
    1625425
    Product Code
    MSD
    Status
    Terminated
    Root Cause
    Component design/selection
    Initiated
    June 5, 2014
    Posted
    September 24, 2014
    Terminated
    April 8, 2015
    Address
    1445 Flat Creek Rd, Athens, TX, 75751-5002

    Description

    UltraStream Exchange Kit Model Numbers 32001524 (24 cm), 32001528 (28cm), 32001532 (32 cm), and 32001536 (36 cm) and 32002540 (40 cm). The Rex Medical UltraStream Chronic Hemodialysis Catheter is a chronic hemodialysis catheter that can achieve high flow rates at low arterial pressures.

    Reason

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

    Distribution

    Nationwide Distribution.

    Quantity

    3,783 units