BEUDAMED
    FDA Enforcement Class II Terminated

    ***Baxter***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-2614-2014 · Reported September 17, 2014

    Enforcement

    Recall Number
    Z-2614-2014
    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***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

    2C8864- Buretrol Solution Set with 150mL CLEARLINK Burette, lots: DR13E08015 DR13E08023 DR13E09013 DR13I26027 DR13I27017 DR13I27025 DR13I28015 DR13I28023 DR13J16027 DR13J17025 DR13J28022 DR13J29020 DR13K01019 DR13K20027 DR13K21025 DR13L19019 DR13L19027 DR14A11017 DR14A14011 DR14A24010 DR14A24036 DR14A31049 DR14B07054 DR14B22012 DR14B28050 DR14C01030 DR14C06013 DR14C06039

    Distribution

    Nationwide Distribution.

    Quantity

    107232