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U.S. Department of Health and Human Services

Class 2 Device Recall Logix TPN Software Solution

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 Class 2 Recall
Logix TPN Software Solution
see related information
Date Posted August 24, 2008
Recall Status1 Terminated on August 25, 2008
Recall Number Z-1640-2008
Recall Event ID 47441
Product Classification Set, I.V. Fluid Transfer - Product Code LHI
Product Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and Logix Compounder Manager (CM) Installation CD, version 3.1.8. The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.
Code Information Software version 1.0.2 (comprised of Logix OE version 1.0.28 and Logix CM version 3.1.8)
Recalling Firm/
Manufacturer
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake, Illinois 60073
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall
Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.
FDA Determined
Cause 2
DESIGN: Software Design
Action Baxter sent the 3/28/08 Urgent Device Correction letter to affected customers, to the attention of the Director of Pharmacy, via first class mail to advise them of the potential inaccuracy of the Delivery Report due to a software anomaly. The accounts were instructed to review each delivery report for accuracy. If the report contains zero actual volumes the user must manually reprint the report. The letter outlined the process for reprinting the Delivery Report. Any questions were directed to the Baxter Nutritional Professional Services at 1-800-422-2751. The accounts were requested complete the enclosed reply form acknowledging receipt and understanding of the letter and dissemination of the information to their staff. A software upgrade will be provided. If you have questions about this letter or you did not receive this letter contact Baxter Nutrition Professional Services at 1-800-422-2751.
Quantity in Commerce 5 units
Distribution Arizona, Minnesota, Wisconsin, Puerto Rico and Canada
Total Product Life Cycle TPLC Device Report

 
1 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
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