BEUDAMED
    FDA Recall Terminated

    Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation

    Recall: Z-1031-2010 · Initiated November 12, 2009

    Recall

    Recall Number
    Z-1031-2010
    Event Number
    53893
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Process control
    Initiated
    November 12, 2009
    Posted
    March 9, 2010
    Terminated
    February 24, 2011
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    Exacta Mix TPN (total parenteral nutrition) Bag, Model 739, 1000mL, Baxa Corporation

    Reason

    TPN bags may leak fluid due to inadequate sealing.

    Action

    Consignees were notified by Baxa Urgent Exactamix Bag Recall letter on 11/12/2009 and then again on 11/17/2009 when more lots were found to be affected. Instructions were to stop use and return all affected product to Baxa. More information is available at 800-678-2292.

    Distribution

    Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Japan, Malaysia, Mexico, New Zealand, Panama, Peru, Singapore, South Korea, Taiwan, and Uruguay.

    Quantity

    2110/50 bag cases