Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
This recall has been terminated (originally issued December 30, 2004).
- Company
- Baxter Healthcare Corp. Rt
- Recall Initiated
- December 8, 2004
- Posted
- December 30, 2004
- Terminated
- November 1, 2005
- Recall Number
- Z-0392-05
- Quantity
- 12 units
- Firm Location
- Round Lake, IL
- Official Source
- View on FDA website ↗
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.
Distribution
Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada
Lot / Code Info
Software version 2.0.9 for Clintec Compounders
Root Cause
Other
Action Taken
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.