Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
This recall has been terminated (originally issued May 25, 2012).
- Company
- Baxa Corporation
- Recall Initiated
- January 19, 2009
- Posted
- May 25, 2012
- Terminated
- September 12, 2012
- Recall Number
- Z-1436-2012
- Quantity
- 667 units
- Firm Location
- Englewood, CO
- Official Source
- View on FDA website ↗
Reason for Recall
Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
Distribution
Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.
Lot / Code Info
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)
Root Cause
Labeling design
Action Taken
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.