Events

Recall of Micromix Compounder Implementation Guide

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
    29017
  • Event Risk Class
    Class 3
  • Event Number
    Z-0989-04
  • Event Initiated Date
    2004-04-30
  • Event Date Posted
    2004-07-20
  • Event Status
    Terminated
  • Event Country
    United States
  • Event Terminated Date
    2006-04-21
  • Event Source
    USFDA
  • Event Source URL
    https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfres/res.cfm?id=32981
  • 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
    unknown device name - Product Code LHI--
  • Reason
    The promotional material for the automix/accusource and micromix compounders and micromix compounder implementation guide contain an incomplete accuracy statement regarding the delivery of each ingredient by the compounders.
  • Action
    Baxter sent Important Product Information letters dated 4/30/04 to all of the compounder customers, informing them of the inaccurate information and requesting that the Nutrition Compounding Simplified brochure, Baxter Info Quick Cards on CD-Rom, versions Q4 2003 and Q2 2003, and pages 60 and 61 of the Micromix Compounder Implementation Guide be destroyed. Replacement pages 60 and 61 of the implementation guide were enclosed with the letter. The letters also listed the accuracy information for each compounder based on Baxter''s supporting data, as well as the specific information regarding the overdelivery alarm limits referenced in the Operator''s Manuals.

Device

Micromix Compounder Implementation Guide
  • Model / Serial
    pages 60 and 61 of the guide
  • Distribution
    Nationwide, United Kingdom, Germany, Chile, Canada, Brazil, El Salvador, Taiwan, Korea, Italy, Saudi Arabia, Israel, China, Indonesia, Hong Kong, Colombia, Argentina, Mexico, Guatemala, Costa Rica, Panama and Honduras.
  • Product Description
    Micromix Compounder Implementation Guide; this guide is distributed by Professional Services as part of the training classes for new Micromix Compounder customers; Baxter Healthcare Corporation, Clintec Nutrition, One Baxter Parkway, Deerfield, IL 60015
  • Manufacturer
    Baxter Healthcare Corp.

Manufacturer

Baxter Healthcare Corp.
  • Manufacturer Address
    Baxter Healthcare Corp., Rt. 120 & Wilson Rd, Round Lake IL 60073
  • Source
    USFDA