FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
- Recall number
- Z-0392-05
- Recalling firm
- Baxter Healthcare Corp.
- Product
- Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
- Status
- Terminated
- Initiated
- 2004-12-08
- Posted
- 2004-12-30
- Terminated
- 2005-11-01
- Reason
- 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.
- Root cause
- Other
- Action
- 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.
- Quantity
- 12 units
- Distribution
- Maryland, Arizona, Indiana, Ohio, Minnesota, Pennsylvania and internationally to Canada
- Lot, serial or model codes
- Software version 2.0.9 for Clintec Compounders
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LHI
- Firm FEI
- 1416980
- Firm city
- Round Lake
- Firm state
- IL
- Firm country
- not on file
Where this comes from
- Register
- FDA Medical Device Recalls (openFDA)
- Publisher
- U.S. Food and Drug Administration (openFDA)
- File
- device-recall-0001-of-0001.json.zip
- sha256
- b87518bfe2e8
- Size
- 288210821 bytes
- Published
- 2026-09-28
- Read
- 2026-09-29T08:25:23.626Z
- Source file
- Source file retained · verify
- Refresh due
- 2026-10-06
Unless otherwise noted, the content, data, documentation, code, and related materials on openFDA is public domain and made available with a Creative Commons CC0 1.0 Universal dedication.
Cite as
FDA Medical Device Recalls (openFDA) (U.S. Food and Drug Administration (openFDA)), device-recall-0001-of-0001.json.zip, sha256 b87518bfe2e8, published 2026-09-28