Date Initiated by Firm | March 28, 2008 |
Date Posted | August 24, 2008 |
Recall Status1 |
Terminated 3 on August 25, 2008 |
Recall Number | Z-1640-2008 |
Recall Event ID |
47441 |
Product Classification |
Intravascular Administration Set - Product Code LHI
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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 IL 60073
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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 | 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 |
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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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