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-0394-05
- 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
- 2004-12-20
- Posted
- 2005-01-13
- Terminated
- 2005-05-19
- Reason
- Logix-CM software version 3.0.4 has not completed its official release process.
- Root cause
- 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
- 5 units
- Distribution
- Arizona, Utah, North Carolina, Wisconsin and California.
- Lot, serial or model codes
- Software version 3.0.4
- 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