Recall Z-1436-2012 ยท LNX
Baxa Corporation
Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.
| Date | May 25, 2012 (initiated Jan 19, 2009) |
| Status | Terminated |
| 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 |
| Quantity | 667 units |
| Distribution | Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.