Events

Recall of Device Recall ExactaMix 2400

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
    38372
  • Event Risk Class
    Class 1
  • Event Number
    Z-1238-2007
  • Event Initiated Date
    2007-06-27
  • Event Date Posted
    2007-09-27
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2007-12-07
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=53501
  • 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
    Pharmacy compounding system - Product Code NEP
  • Reason
    A software defect could allow up to 50ml of extra volume being added to a tpn solution.
  • Action
    All customers were notified via telephone on 06/27/2007 with follow-up of a faxed/emailed Urgent Product Recall letter dated 27 June 2007, detailing the software defect. End users were given a work around procedure to use until conversion back to version 1.06 could be scheduled. An additional copy of the recall letter was sent by FedEx.

Device

Device Recall ExactaMix 2400
  • Model / Serial
    Version 1.07 of the EM2400 Operating Software. (Serial Numbers: 36805,36806,36356,36399,36804,36799,36797,36398,32438,36798,36460,36794,32346,36800,36801,36802,36803,(37767-36773), (36788-36793),36795 and 36796 (foreign)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Class I Recall-Worldwide Distribution: USA including states of CA, CO, FL, KY, MI, NY, OH, OR, and TX and the UK
  • Product Description
    Exacta-Mix 2400, OS v1.07, Model No. 8300-0073, Pharmacy Compounding System, Baxa Corporation, Englewood, CO 80112.
  • Manufacturer
    Baxa Corporation

Manufacturer

Baxa Corporation
  • Manufacturer Address
    Baxa Corporation, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Source
    USFDA