Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Class 3 Device Recall Micromix Compounder Implementation Guide

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
  Class 3 Device Recall Micromix Compounder Implementation Guide see related information
Date Initiated by Firm April 30, 2004
Date Posted July 20, 2004
Recall Status1 Terminated 3 on April 21, 2006
Recall Number Z-0989-04
Recall Event ID 29017
Product Classification unknown device name - Product Code LHI--
Product 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
Code Information pages 60 and 61 of the guide
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 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.
FDA Determined
Cause 2		 Other
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.
Quantity in Commerce 500 devices
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.
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
-
-