BEUDAMED
    FDA Recall Terminated

    Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.

    Recall: Z-1122-2014 · Initiated February 17, 2014

    Recall

    Recall Number
    Z-1122-2014
    Event Number
    67545
    Firm
    WalkMed Infusion, LLC
    FEI Number
    3000204189
    Product Code
    FRN
    Status
    Terminated
    Root Cause
    Labeling design
    Initiated
    February 17, 2014
    Posted
    March 3, 2014
    Terminated
    October 6, 2014
    Address
    96 Inverness Drive East, Suite J, Englewood, CO, 80112-5311

    Description

    Triton FP Infusion Pump, Part Number 400000, packaged in boxes. The Triton Volumetric Infusion Pump is indicated for delivering infusions of medications, as well as providing TPN (Total Parenteral Nutrition) and PCA (Patient Control Analgesia). It is intended for use in hospitals, ambulatory & nursing home (extended care) settings, and home care environments.

    Reason

    WalkMed Infusion is initiaing a recall on their Triton FP Infusion Pump, Part Number 400000 due to the label on the right side of the pump containing an incorrect instruction.

    Action

    WalkMed Infusion sent an Important Medical Device Recall letter dated February 14, 2014, to all affected customers. The letter identified the product the problem and the action customers need to take. Our records Indicate that you have purchased product affected by this recall (see the attached list).Our sales representative will contact you to determine a plan for label replacement for your units. Replacement of the label will include a simple process of removing the old label (PN 300063), replacing it with a corrected label(PN 400033) and documenting completion of the replacement. This action can be completed by you,your customers,our sales representative, or by returning the infusion pump to WalkMed Infusion. For further questions please call (720) 351-4934 or (720) 351-4965. Product will be corrected in the field when possible and supported by the customer. Otherwise, WalkMed Infusion employees with travel to the customer and complete the correction activities.

    Distribution

    US Distribution including the states of IL, MA, KS, and, NJ.

    Quantity

    797