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Terminated

Abacus TPN Calculating Software Product Usage: LIMS Windows-based program for order entry and TPN calculation.

FDA Recall Z-1436-2012 · Posted 2012-05-25

Recalling FirmBaxa Corporation
Recall StatusTerminated
Product CodeLNX
Date Initiated2009-01-19
Date Terminated2012-09-12
Product Quantity667 units

Reason for Recall

Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.

Firm 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.

Root Cause

Labeling design

Distribution Pattern

Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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