Events

Recall of Device Recall Abacus TPN Calculating Software

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
    52013
  • Event Risk Class
    Class 1
  • Event Number
    Z-1436-2012
  • Event Initiated Date
    2009-01-19
  • Event Date Posted
    2012-05-25
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2012-09-12
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=81907
  • 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
    Medical computers and software - Product Code LNX
  • Reason
    Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
  • Action
    Baxa Corporation sent a "Safety Alert" letter dated January 19, 2009 via FedEx to all affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to ensure that users create either a salt-based template OR an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were provided a list of safe practices to follow on the enclosed ISMP Safety Alert. Customers were advised upon receipt of the Safety Alert that Baxa Technical Support will review and address any issues with the customer on their configuration setup for calcium and magnesium. For questions contact Baxa Technical Support at 1-800-678-2292.

Device

Device Recall Abacus TPN Calculating Software
  • Model / Serial
    Catalogue Numbers:  8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus ME)
  • Product Classification
    General Hospital and Personal Use Devices
  • Device Class
    Unclassified
  • Implanted device?
    No
  • Distribution
    Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.
  • Product Description
    Abacus TPN Calculating Software || Product Usage: || LIMS Windows-based program for order entry and TPN calculation.
  • Manufacturer
    Baxa Corporation

Manufacturer

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