Events

Recall of ABACUS

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

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
    70946
  • Event Risk Class
    Class 2
  • Event Number
    Z-1628-2015
  • Event Initiated Date
    2015-04-08
  • Event Date Posted
    2015-05-18
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-12-01
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=135694
  • 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
    System/device, pharmacy compounding - Product Code NEP
  • Reason
    Baxter corporation is conducting a field action for the abacus se and me models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.
  • Action
    Baxter sent a Safety Alert letter dated April 8, 2015 to affected customers via USPS first class mail. The letter identified the affected product, problem and actions to be taken. Customers were asked to 1) contact Baxter Technical Services if you need to restore the ABACUS databse, 2) foword a copy of this Safety Alert letter to other facilities or departments within your institution to ensure that those locations are awae of this action, and 3) complete the customer reply form and return it to Baxter by faxing to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. For questions contact the Center for One Baxter at 800-422-9837.

Device

ABACUS
  • Model / Serial
    Product Codes: 8300-0168 ,8300-0169 ,8300-0157 ,8300-0158 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047,
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US Nationwide
  • Product Description
    ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition) || Product Usage: || The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • Manufacturer Address
    Baxter Corporation Englewood, 014445 Grasslands Dr, Englewood CO 80112-7062
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA