BEUDAMED
    FDA Recall Terminated

    ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    Recall: Z-1966-2011 · Initiated March 8, 2011

    Recall

    Recall Number
    Z-1966-2011
    Event Number
    58304
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    LHI
    Status
    Terminated
    Root Cause
    Nonconforming Material/Component
    Initiated
    March 8, 2011
    Posted
    April 12, 2011
    Terminated
    March 23, 2012
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    ExactaMix EVA Container, 2000mL, REF: 740, Sterile R, Baxa Corporation, Englewood, CO 80112. A plastic container used to hold large-volume sterile solutions to be administered to a patient through an intravascular administration set

    Reason

    TPN bags may leak during filling operation, due to bag manufacturing error.

    Action

    The firm, BAXA, sent a "ExactaMix Bag Product Notice" dated March 8, 2011 to its customers. The notice described the product, problem and actions to be taken. The customers were instructed to do the following: If they do not intend to use the manual addition port, verify that the cap is firmly seated onto the port by gently tugging on the cap. If they do intend to use the manual addition port, they should snap off the additive port cap prior to compounding the bag. If they encounter a faulty additive port, contact Baxa Technical Support to receive credit and/or replacement on defective product only. To return affected bags, follow the instructions provided in the notice if the bags were purchased directly from Baxa or purchased from wholesaler, distributor or other 3rd party vendor. Additional copies of the return form can be retrieved by going to www.baxa.com/ebug OR by calling Baxa Technical Support at 800-678-2292. If you have any questions or concerns, contact the Sr. Vice President, Quality and Regulatory at (303) 400-2838 or Baxa Technical Support at 800-678-2292.

    Distribution

    Worldwide distribution: USA (nationwide) and countries including: Argentina, Australia, Bermuda, Brazil, Canada, Chile, China, Colombia, Hong Kong, Ireland, Japan, Malaysia, Mexico, New Zealand, Panama, Puerto Rico, Singapore, South Korea, Taiwan, UK, Uruguay, Venezuela.

    Quantity

    2,791,150 bags