BEUDAMED
    FDA Enforcement Class I Terminated

    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

    Recall: Z-0015-2013 · Reported October 17, 2012

    Enforcement

    Recall Number
    Z-0015-2013
    Event ID
    63059
    Classification
    Class I
    Status
    Terminated
    Product Type
    Devices
    Firm
    Baxter Healthcare Corp.
    Voluntary / Mandated
    Voluntary: Firm initiated
    Initial Notification
    Letter
    Report Date
    October 17, 2012
    Initiation Date
    September 7, 2012
    Classification Date
    October 9, 2012
    Termination Date
    December 29, 2017
    Address
    Rt. 120 & Wilson Rd, N/A, Round Lake, IL, 60073, United States

    Description

    Baxter Clearlink System Buretrol Solution Set, 115" (2.9 m) with 150 mL Clearlink Burette (Ball-Valve Drip Chamber) (Non-DEHP); a sterile Rx IV fluid pathway device Product Usage: The device is used for the administration of fluids from a container into the patient's vascular system through a vascular access device.

    Reason

    Baxter has determined that the ball-valve feature of the Buretrol Solution Sets may not function as expected, allowing air to flow past the valve and into the tubing at the completion of dose within the burette.

    Code Info

    product code 2H8819, all lots

    Distribution

    Worldwide Distribution - US Nationwide and Internationally to Canada, Costa Rica, Australia, New Zealand, Hong Kong, and the United Kingdom.

    Quantity

    488,504 units