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U.S. Department of Health and Human Services

Class 3 Device Recall Brochure titled "Nutrition Compounding Simplified"

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  Class 3 Device Recall Brochure titled "Nutrition Compounding Simplified" 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-0988-04
Recall Event ID 29017
Product Classification unknown device name - Product Code LHI--
Product Compounding Brochure titled ''Nutrition Compounding Simplified'', Lit #800415, print date January 2002; the brochure is applicable to the Automix Plus High Speed Compounder System, product 2M8075, the Automix High Speed Compounder System, product 2M8077, the Automix 3+3 Compounder System, product 2M8286, the Automix 3+3 Compounder with Accusource Monitoring System, product 2M8287, the Micromix Compounder System, 1.0 mL, product 2M8290, and the Micromix Compounder System, 0.3 mL, product 2M8290L; Baxter Healthcare Corporation, Clintec Nutrition, One Baxter Parkway, Deerfield, IL 60015
Code Information Lit #800415, print date January 2002  This brochure was distributed individually and as part of the Baxter Info Quick Card (on CD-Rom), versions Q4 2003 and Q2 2003
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 1,366 units
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.
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