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U.S. Department of Health and Human Services

Class 1 Device Recall Abacus TPN Calculating Software

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  Class 1 Device Recall Abacus TPN Calculating Software see related information
Date Initiated by Firm January 19, 2009
Date Posted May 25, 2012
Recall Status1 Terminated 3 on September 12, 2012
Recall Number Z-1436-2012
Recall Event ID 52013
Product Classification Medical computers and software - Product Code LNX
Product Abacus TPN Calculating Software

Product Usage:
LIMS Windows-based program for order entry and TPN calculation.
Code Information 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) 
Recalling Firm/
Manufacturer		 Baxa Corporation
14445 Grasslands Dr
Englewood CO 80112
For Additional Information Contact Anne Szilagyi
800-678-2292
Manufacturer Reason
for Recall		 Ordering salt-based ingredients on an ion-based template resulted in medication errors when calculating amounts of ingredients required.
FDA Determined
Cause 2		 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 in Commerce 667 units
Distribution Worldwide Distribution - US (Nationwide) and the countries of: Canada, China, Australia, Panama and Columbia.
Total Product Life Cycle TPLC Device Report
1 A record in this database is created when a firm initiates a correction or removal action. The record is updated if the FDA identifies a violation and classifies the action as a recall, and it is updated for a final time when the recall is terminated. Learn more about medical device recalls.
2 Per FDA policy, recall cause determinations are subject to modification up to the point of termination of the recall.
3 For details about termination of a recall see Code of Federal Regulations (CFR) Title 21 §7.55.
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