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U.S. Department of Health and Human Services

Class 2 Device Recall LogixCM Compounder Software

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  Class 2 Device Recall LogixCM Compounder Software see related information
Date Initiated by Firm December 08, 2004
Date Posted December 30, 2004
Recall Status1 Terminated 3 on November 01, 2005
Recall Number Z-0392-05
Recall Event ID 30609
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
Code Information Software version 2.0.9 for Clintec Compounders
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
A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being used with the Logix software.
FDA Determined
Cause 2
Other
Action Urgent Device Correction letters dated 12/8/04 were sent to the end users via overnight mail. The accounts were informed of the potential for omission of an ingredient if there are duplicate drug Id''s in the order, and were requested to complete and fax the customer reply form to Baxter at 847-270-5457, indicating if they are currently using Logix-CM software. Upon receipt of the reply form, Baxter will schedule a visit to the facility to examine the base and additive inventory information in their MOS database to confirm that there are no duplicate Drug ID numbers and that this issue has not occurred at the facility. They will also secure the MOS database to ensure that the situation will not be able to occur. Any questions were directed to Baxter Clintec Nutrition, option 1, at 1-800-422-2751.
Quantity in Commerce 12 units
Distribution Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada
Total Product Life Cycle TPLC Device Report

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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