Events

Recall of Device Recall EXACTAMIX Compounder

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

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
    68506
  • Event Risk Class
    Class 2
  • Event Number
    Z-1963-2014
  • Event Initiated Date
    2014-06-10
  • Event Date Posted
    2014-07-01
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2017-02-22
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=128106
  • 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
    If the universal ingredient (ui) in an active configuration is changed using the configuration editor, a flush of the outlet pump tube will not be initiated by the software. it could result in the original ui remaining in the tube which could be delivered into the next bag.
  • Action
    An Urgent Device Correction communication via 1st class mail was mailed on July 14, 2014, informing customers of a potential issue if the universal ingredient in an active configuration is changed using the Configuration Editor rather than following the normally prescribed and supported methods as outlined in the Operator Manual.

Device

Device Recall EXACTAMIX Compounder
  • Model / Serial
    model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide
  • Product Description
    EXACTAMIX 1200 Compounder, model numbers 1200-DY, 1200-DX, 1200-DYR and 1200-DXR; EM1200 DY Display, Replacement EM 1200 DY Display. EXACTAMIX 2400 Compounder model numbers 2400-DY, 2400-DX, 2400-DYR and 2400-DYX. Baxa Corporation. An automated pumping system that compounds multiple sterile ingredients into a finished solution in a single patient IV administration bag.
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., 1 Baxter Pkwy, Deerfield IL 60015-4625
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA