BEUDAMED
    FDA Recall Terminated

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.

    Recall: Z-0134-2012 · Initiated August 26, 2011

    Recall

    Recall Number
    Z-0134-2012
    Event Number
    60168
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Employee error
    Initiated
    August 26, 2011
    Posted
    October 28, 2011
    Terminated
    October 31, 2011
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Flo-Gard 6301 Dual Channel Volumetric Infusion Pump; Baxter Healthcare Corporation, Deerfield, IL 60015; Product Code # 2M8064. The Flo-Gard Volumetric Infusion Pumps are an electromechanical pump used for intravenous infusion of fluids at user-selected rates.

    Reason

    The Flo-Gard infusion Pump was released to the customer with OOS values for the Air Sensor Calibrations with the Air in Tubing test.

    Action

    A Baxter Healthcare technician initially notified the sole customer on August 26, 2011 of the defective product and requested that the product be quarantined. On September 14, 2011 a technician visited the site to correct the problem observed on the Flo-Gard Infusion Pump. All required tests were performed and the results were found acceptable.

    Distribution

    Distributed only in Puerto Rico.

    Quantity

    1 unit