BEUDAMED
    FDA Recall Terminated

    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.

    Recall: Z-0598-2012 · Initiated May 8, 2009

    Recall

    Recall Number
    Z-0598-2012
    Event Number
    60521
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    May 8, 2009
    Posted
    January 11, 2012
    Terminated
    January 3, 2012
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Baxter Colleague CX Infusion Pump, Single Channel Volumetric Infusion Pumps. Product Code: 2M8161.

    Reason

    There was no documentation to show the required tests were performed following the replacement of the battery and battery harness.

    Action

    Baxter sent a service technician to the consignee location on 05/08/2009 to perform the battery check and discharge test. The pump was found to be within specification.

    Distribution

    Puerto Rico

    Quantity

    one pump