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U.S. Department of Health and Human Services

Class 2 Device Recall ABACUS

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  Class 2 Device Recall ABACUS see related information
Date Initiated by Firm April 08, 2015
Date Posted May 18, 2015
Recall Status1 Terminated 3 on December 01, 2016
Recall Number Z-1628-2015
Recall Event ID 70946
Product Classification System/device, pharmacy compounding - Product Code NEP
Product ABACUS SE (Single-Workstation Edition) and ABACUS ME (Multi-Workstation Edition)

Product Usage:
The ABACUS Software is a Windows-based order entry software application for comprehensive total parenteral nutrition (TPN) calculations and label printing.
Code Information Product Codes: 8300-0168 ,8300-0169 ,8300-0157 ,8300-0158 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047 ,8300-0046 ,8300-0047,
Recalling Firm/
Manufacturer		 Baxter Corporation Englewood
014445 Grasslands Dr
Englewood CO 80112-7062
For Additional Information Contact Center for One Baxter
800-422-9837
Manufacturer Reason
for Recall		 Baxter Corporation is conducting a field action for the ABACUS SE and ME models due to the possibility that the compounder will load the incorrect formula upon scanning the bag label when two or more different formula files have been created with the same order number.
FDA Determined
Cause 2		 Software design
Action Baxter sent a Safety Alert letter dated April 8, 2015 to affected customers via USPS first class mail. The letter identified the affected product, problem and actions to be taken. Customers were asked to 1) contact Baxter Technical Services if you need to restore the ABACUS databse, 2) foword a copy of this Safety Alert letter to other facilities or departments within your institution to ensure that those locations are awae of this action, and 3) complete the customer reply form and return it to Baxter by faxing to 224-270-5457 or scanning and e-mailing it to fca@baxter.com. For questions contact the Center for One Baxter at 800-422-9837.
Quantity in Commerce 882
Distribution Worldwide Distribution - US Nationwide
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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