FDA Medical Device Recalls (openFDA)
Baxter Healthcare Corp.: LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; 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. Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders.
- Recall number
- Z-3276-2011
- Recalling firm
- Baxter Healthcare Corp.
- Product
- LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; 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. Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders.
- Status
- Terminated
- Initiated
- 2011-08-15
- Posted
- 2011-09-23
- Terminated
- 2017-01-05
- Reason
- There is the potential for an order entry error during use of the LOGIX Order Entry (OE) software. When adding ingredients to a TPN order, the user can accept the pre-populated "per units" of "Bag" or select other "per units". A dosing error may occur if the user does not select the prescribed "per units" for the added ingredient.
- Root cause
- Software design
- Action
- Baxter Healthcare Corp. sent an "Urgent Device Correction" letters dated August 15, 2011 which included LOGIX OE screen illustrations of a representative neonate and adult patient, via first class mail to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed to follow safe compounding practice, which includes verifying that the ingredient per units entered match the TPN prescription prior to preparation. Baxter requests that customers communicate this issue to all personnel responsible for LOGIX order entry and order authorization at their facility. Customers are instructed to retain a copy of the letter at each computer on which LOGIX OE software is installed. The customers were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Medical Information Services at 1-800-422-2751.
- Quantity
- 95 units
- Distribution
- Worldwide Distribution - USA (nationwide) including Puerto Rico and the country of Canada.
- Lot, serial or model codes
- catalog 2M8410, software versions 1.1.0, 1.1.1 and 1.1.2
- 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