BEUDAMED
    FDA Recall Terminated

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    Recall: Z-0882-04 · Initiated April 13, 2004

    Recall

    Recall Number
    Z-0882-04
    Event Number
    28824
    Firm
    Baxter Healthcare Corp. Rt.
    FEI Number
    1416980
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    April 13, 2004
    Posted
    July 20, 2004
    Terminated
    February 2, 2011
    Address
    120 & Wilson Rd, Round Lake, IL, 60073

    Description

    Colleague 3 CX Triple Channel Volumetric Infusion Pumps, product code 2M8163; Baxter Healthcare Corporation, Deerfield, IL 60015 U.S.A., Made in Singapore; color display screen

    Reason

    Ink deterioration of the letters, numbers and symbols of the programming and pump channel keypads, which may impact the legibility of the keys over time.

    Action

    Baxter sent urgent device correction letters dated 4/13/04 to the direct accounts to the attention of the Director of Biomedical Engineering on the same date. The letters informed the accounts of the ink deterioration of the letters, numbers and symbols on the Colleague Volumetric Infusion Pump programming and pump channel keypads, and informed them that over time such ink deterioration may impact legibility of the keys. The letters provided a listing of model numbers and serial numbers of pumps at their facility which may have potentially affected keypads. The accounts were given a sample of the overlay to be applied over the programming keypad and installation instructions as an interim fix while replacement keypads are obtained and installed as the pumps are processed through their depot repair centers. The accounts were requested to complete the attached reply form and return it via fax to Baxter. The completed form acknowledges receipt of the recall letter, verifies the model numbers and serial numbers of the pumps at the facility and indicates the number of overlays needed. Any questions were directed to Baxter at 1-800-843-7867. On 6/9/05, Baxter sent Urgent Device Correction letters to the accounts, to the attention of the Director of Biomedical Engineering, advising them that the replacement pump programming and pump channel keypads were now available.

    Distribution

    Nationwide, and internationally to Australia, the Bahamas, Belgium, Brazil, Canada, Colombia, El Salvador, Guatemala, Honduras, Israel, Lebanon, Mexico, New Zealand, Panama, the Philippines, Saudi Arabia, South Africa, Taiwan, Turkey, United Arab Emirates and the United Kingdom.