BEUDAMED
    FDA Recall Terminated

    Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.

    Recall: Z-2142-2010 · Initiated May 26, 2010

    Recall

    Recall Number
    Z-2142-2010
    Event Number
    55931
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    KPE
    Status
    Terminated
    Root Cause
    Process design
    Initiated
    May 26, 2010
    Posted
    August 2, 2010
    Terminated
    August 4, 2011
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    Exacta-Mix EVA Container, Sterile R, 4000 mL, Order No. REF: 142, Baxa Corporation.

    Reason

    Fill port cap on TPN bags may become detached prior to use, thus compromising the sterility of the fluid pathway.

    Action

    Consignees were notified by e-mail and Baxa Bag Product Notice letter on 05/26/2010 with instructions to not use any bags if the fill port cap is detached. Photos of a detached cap and properly attached cap were included. Defective bags could be returned to Baxa for credit. Information available at 800-678-2292.

    Distribution

    Worldwide distribution, including USA, Argentina, Australia, Bermuda, Brazil, Canada, China, Colombia, Hong Kong, Malaysia, Mexico, New Zealand, Pakistan, Panama, South Korea, Taiwan, United Kingdom, and Uruguay.

    Quantity

    263,150 bags