FDA Medical Device Recalls (openFDA)
Baxa Corporation: Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
- Recall number
- Z-1436-2012
- Recalling firm
- Baxa Corporation
- Product
- Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
- Status
- Terminated
- Initiated
- 2009-01-19
- Posted
- 2012-05-25
- Terminated
- 2012-09-12
- Reason
- Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
- Root cause
- Labeling design
- Action
- Baxa Corporation sent a "Safety Alert" letter dated January 19, 2009 via FedEx to all affected customers. The letter described the affected product, problem, and actions to be taken. Customers were instructed to ensure that users create either a salt-based template OR an ion-based template for ordering, and that both methods of ordering are not used in one template. Customers were provided a list of safe practices to follow on the enclosed ISMP Safety Alert. Customers were advised upon receipt of the Safety Alert that Baxa Technical Support will review and address any issues with the customer on their configuration setup for calcium and magnesium. For questions contact Baxa Technical Support at 1-800-678-2292.
- Quantity
- 667 units
- Distribution
- Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.
- Lot, serial or model codes
- Catalogue Numbers: 8300-0045: Abacus Calculator Only (Abacus CE) 8300-0046: Abacus Single Work Station (Abacus SE) 8300-0047: Abacus Multi-Work Station (Abacus ME)
- 510(k) numbers
- not on file
- PMA numbers
- not on file
- Product code
- LNX
- Firm FEI
- 1419106
- Firm city
- Englewood
- Firm state
- CO
- 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