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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 Softwaresee related information
Date Initiated by FirmDecember 20, 2004
Date PostedJanuary 13, 2005
Recall Status1 Terminated 3 on May 19, 2005
Recall NumberZ-0394-05
Recall Event ID 30714
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
ProductLogix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
Code Information Software version 3.0.4
FEI Number 1416980
Recalling Firm/
Manufacturer		 Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information ContactCenter for One Baxter
800-422-9837
Manufacturer Reason
for Recall		Logix-CM software version 3.0.4 has not completed its official release process.
FDA Determined
Cause 2		Other
ActionUrgent Product Recall letters dated 12/20/04 were sent to the end users via overnight mail. The accounts were informed that software version 3.0.4 has not been officially released and must be removed from their compounders. They 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 remove Logix-CM software version 3.0.4 from their compounder and revert the software back to the configuration prior to Logix-CM 3.0.4 placement. Any questions were directed to Baxter Clintec Nutrition, option 1, at 1-800-422-2751.
Quantity in Commerce5 units
DistributionArizona, Utah, North Carolina, Wisconsin and California.
Total Product Life CycleTPLC 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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