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Class 2 Device Recall LogixCM Compounder Software |
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Date Initiated by Firm |
December 20, 2004 |
Date Posted |
January 13, 2005 |
Recall Status1 |
Terminated 3 on May 19, 2005 |
Recall Number |
Z-0394-05 |
Recall Event ID |
30714 |
Product Classification |
Set, I.V. Fluid Transfer - Product Code LHI
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Product |
Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073 |
Code Information |
Software version 3.0.4 |
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
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Manufacturer Reason for Recall |
Logix-CM software version 3.0.4 has not completed its official release process.
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FDA Determined Cause 2 |
Other |
Action |
Urgent 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 Commerce |
5 units |
Distribution |
Arizona, Utah, North Carolina, Wisconsin and California. |
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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