Events

Recall of Device Recall Abacus 3.1

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
    68256
  • Event Risk Class
    Class 2
  • Event Number
    Z-1847-2014
  • Event Initiated Date
    2014-05-28
  • Event Date Posted
    2014-06-22
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2016-08-08
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=127226
  • 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 initiating a field correction following an upgrade to abacus software v3.1, when clinimix 4.25110 is used in an order, the nutritional summary and any labels containing energy information may display 1,000 times less protein than is actually present in the solution.
  • Action
    Baxter sent an Urgent Device Correction letter dated May 27, 2014 via certified mail to affected customers. The letter identified the affected product, problem and actios to be taken. Customers were instructed to: 1. Review and distribute this communication to pharmacy staff and compounding staff that use ABACUS software. This notice is intended only for customers that have upgraded to version 3.1 of the software. 2. Please acknowledge receipt of this notification by completing the enclosed customer reply form and return it to Baxter by either faxing it to 1-224-270-5457 or scanning and e-mailing it to fca@baxter.com. 3. If you have distributed ABACUS to other facilities, please notify the end users in accordance with your customary procedures. For questions call Baxter Techenical Support line at 1-800-678-2292.

Device

Device Recall Abacus 3.1
  • Model / Serial
    Product Code: 8300-0167, 8300-0168, 8300-0169
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    2
  • Implanted device?
    No
  • Distribution
    US Nationwide Distribution and the state of VA.
  • Product Description
    Abacus 3.1, Pharmacy Calculator || Product Usage: || Provide pharmacy calculations for automated compounding.
  • Manufacturer
    Baxter Corporation Englewood

Manufacturer

Baxter Corporation Englewood
  • Manufacturer Address
    Baxter Corporation Englewood, 14445 Grasslands Dr, Englewood CO 80112-7062
  • Manufacturer Parent Company (2017)
    Baxter International
  • Source
    USFDA