BEUDAMED
    FDA Recall Terminated

    The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intravascular administration.

    Recall: Z-1371-2012 · Initiated June 3, 2008

    Recall

    Recall Number
    Z-1371-2012
    Event Number
    52174
    Firm
    Baxa Corporation
    FEI Number
    1419106
    Product Code
    NEP
    Status
    Terminated
    Root Cause
    Device Design
    Initiated
    June 3, 2008
    Posted
    April 5, 2012
    Terminated
    April 10, 2012
    Address
    14445 Grasslands Dr, Englewood, CO, 80112

    Description

    The EM 2400 is a Pharmacy Compounding System consisting of three sub-systems for compounding solutions for intravascular administration. Pharmacy compounding system for mixing ingredients for intravascular administration.

    Reason

    Remote possibility of an unintended ingredient delivery as a result of a damaged valve actuator on the EM 2400.

    Action

    The firm, Baxa, sent a "Exacta-Mix 2400 Compounder Safety Alert" dated June 3, 2008 to all customers. The alert describes the product, problem and actions to be taken. The customers were instructed to not use the main module if any of the 24 valve actuators are damaged; do not infuse any bags if damage is noticed after they have been pumped; do not try to repair or adjust a damaged or bent valve actuator; immediately alert all compounder users of this issue to ensure that when the device is used, the valve actuators are always inspected for damage;" inspect all valve acutators before setup and after tear-down to ensure they are not damaged or bent. Do not use the compounder if the valve actuators are damaged or bent."; and if a damaged or bent valve is noticed after using the EM2400, immediately hold all pumped bags and contact Baxa Technical Support. If you need additional assistance, please contact Baxa Technical Support (800-678-2292). Technical Support is available 24 hours a day, 7 days a week.

    Distribution

    Worldwide distribution: USA (nationwide) and countries including: Australia, Canada, China, New Zealand, and United Kingdom.

    Quantity

    1000 units (approximately)