BEUDAMED
    FDA Enforcement Class II Terminated

    ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***

    Recall: Z-2615-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2615-2014
    Event ID
    68843
    Classification
    Class II
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    September 17, 2014
    Initiation Date
    July 14, 2014
    Classification Date
    September 9, 2014
    Termination Date
    March 15, 2016
    Address
    1 Baxter Pkwy, N/A, Deerfield, IL, 60015-4625, United States

    Description

    ***Baxter***Non-DEHP***BURETROL Solution Set 105" (2.7 m), 150 mL Burette***Drip Chamber Filter Valve 3 Luer Activated Valves***Male Luer Lock Adapter***with Retractable Collar***Fluid path is Sterile, Nonpyrogenic.***Indications for Use: For the administration of fluids from a container into the patient's vascular system through a vascular access device.***

    Reason

    Baxter Healthcare Corporation is voluntarily issuing a recall for specific lots of Buretrol Solution set product codes due to complaints for separation between the burette chamber and the drip chamber. Affected product codes are: 2C7564, 2C8864 and 2H8864.

    Code Info

    2H8864- Non-DEHP Buretrol Solution Set, 150 mL CLEARLINK Burette, lots: DR13E10011 DR13E10029 DR13E11019 DR14A13013 DR14C08043

    Distribution

    Nationwide Distribution.

    Quantity

    11184