Events

Recall of Device Recall ExactaMix 1200 and 2400 Compounders

According to U.S. Food and Drug Administration, this recall involved a device in United States that was produced by Baxa Corporation.

What is this?

A correction or removal action taken by a manufacturer to address a problem with a medical device. Recalls occur when a medical device is defective, when it could be a risk to health, or when it is both defective and a risk to health.

Learn more about the data here
  • Type of Event
    Recall
  • Event ID
    65215
  • Event Risk Class
    Class 2
  • Event Number
    Z-1752-2013
  • Event Initiated Date
    2013-06-04
  • Event Date Posted
    2013-07-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2015-10-16
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=118289
  • Notes / Alerts
    U.S. data is current through June 2018. All of the data comes from the U.S. Food and Drug Administration, except for the category Manufacturer Parent Company.
    The Parent Company was added by ICIJ.
    The parent company information is based on 2017 public records.
  • Extra notes in the data
    Set, i.V. Fluid transfer - Product Code LHI
  • Reason
    Baxter healthcare is recalling certain exactamix automated compounding devices due to the complementary metal oxide semi-conductor battery failure resulting in resetting the internal clock of the device to midnight december 31, 2010.
  • Action
    On 6/04/13, customers were notified by 1st class mailing with mitigating instructions including reminding customers that the battery failure results in a failure of the ExactaMix system to alert the user to replace the disposable set after 24 hours of use. Users should not rely on the alert to trigger the daily replacement of disposable sets. Users should also confirm the correct time and date at the setup of each use. If the compounder displays an incorrect time and date, customers are to contact Baxter Technical Support.

Device

Device Recall ExactaMix 1200 and 2400 Compounders
  • Model / Serial
    ExactaMix 1200 serial numbers 45004-45481 (sequentially), and ExactaMix 2400 serial numbers 40005-40335.
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution-USA (nationwide) including Puerto Rico, and the countries of Canada, Latin America, Europe/Middle East/Africa, and Taiwan.
  • Product Description
    ExactaMix 1200 and 2400 Compounders. || Used as an automated pumping system that compounds multiple sterile ingredients into a finished solution.
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • Manufacturer Address
    Baxa Corporation, 9540 Maroon Cir Unit 400, Englewood CO 80112-5731
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA