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U.S. Department of Health and Human Services

Class 2 Device Recall Logix Order Entry (OE) Software

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  Class 2 Device Recall Logix Order Entry (OE) Software see related information
Date Initiated by Firm August 15, 2011
Date Posted September 23, 2011
Recall Status1 Terminated 3 on January 05, 2017
Recall Number Z-3276-2011
Recall Event ID 59734
Product Classification System/device, pharmacy compounding - Product Code LHI
Product LOGIX Order Entry (OE) Software, all versions, catalog 2M8410; Baxter Healthcare, Deerfield, IL 60015; The software is included in a number of Baxter's pharmacy compounders. The software assists the pharmacist in management of compounding, creating and authorizing nutritional solutions intended for IV administration.

Product Usage: The LOGIX OE application is an order entry system intended for use with Baxters LOGIX CM software. The software program aids the pharmacist in creating and authorizing nutritional solution orders.
Code Information catalog 2M8410, software versions 1.1.0, 1.1.1 and 1.1.2
Recalling Firm/
Baxter Healthcare Corp.
Rt. 120 & Wilson Rd
Round Lake IL 60073
For Additional Information Contact Center for One Baxter
Manufacturer Reason
for Recall
There is the potential for an order entry error during use of the LOGIX Order Entry (OE) software. When adding ingredients to a TPN order, the user can accept the pre-populated "per units" of "Bag" or select other "per units". A dosing error may occur if the user does not select the prescribed "per units" for the added ingredient.
FDA Determined
Cause 2
Software design
Action Baxter Healthcare Corp. sent an "Urgent Device Correction" letters dated August 15, 2011 which included LOGIX OE screen illustrations of a representative neonate and adult patient, via first class mail to all affected customers. The letter identified the product, problem and actions to be taken. The customers were instructed to follow safe compounding practice, which includes verifying that the ingredient per units entered match the TPN prescription prior to preparation. Baxter requests that customers communicate this issue to all personnel responsible for LOGIX order entry and order authorization at their facility. Customers are instructed to retain a copy of the letter at each computer on which LOGIX OE software is installed. The customers were also requested to complete the attached customer reply form and fax it to Baxter at the number provided on the form. Any questions regarding the communication were directed to Baxter's Medical Information Services at 1-800-422-2751.
Quantity in Commerce 95 units
Distribution Worldwide Distribution - USA (nationwide) including Puerto Rico and the country of Canada.
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.