BEUDAMED
    FDA Recall Terminated

    Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.

    Recall: Z-1420-2012 · Initiated May 8, 2009

    Recall

    Recall Number
    Z-1420-2012
    Event Number
    52120
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Labeling False and Misleading
    Initiated
    May 8, 2009
    Posted
    April 13, 2012
    Terminated
    April 13, 2012
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    Baxa EVA TPN bags for administering parenteral nutrition solutions. Sold under three brand names: Exacta Mix EVA Bags, Exacta Mix Dual-Chamber EVA Halobag, and Baxa Calibration Bags.

    Reason

    Spike port flor EVA TPN Bags contains low levels of DEHP which could leach out.

    Action

    Baxa sent a Customer Notice letter dated May 8, 2009, to all affected customers. The letter identified the product the problem and the action needed to be taken by the customer. Current Baxa product is mislabeled as non-DEHP but this does not present a risk to patients. Baxa is committed to providing products that are non-DEHP. We are working with our supplier to replace the spike port with a non-DEHP as soon as possible. In the meantime, product labeling will be updated to reflect this finding. For further questions please call (303) 690-4204.

    Distribution

    Worldwide Distribution -- USA (nationwide)

    Quantity

    347,494 cases/ 50 bags each