Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
FDA device recall Z-1436-2012 · posted 2012-05-25 · Terminated
Recall details
- Recalling firm
- Baxa Corporation
- Reason for recall
- Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
- 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.
- Root cause
- Labeling design
- Status
- Terminated
- Product code
- LNX
- Quantity affected
- 667 units
- Distribution
- Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.
- Date initiated
- 2009-01-19
- Date posted
- 2012-05-25
- Date terminated
- 2012-09-12
- Location
- Englewood, CO
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