Logix TPN Software Solution, catalog 2M8410, consists of the Logix Order Entry (OE) Installation CD, version 1.0.28 and

FDA device recall Z-1640-2008 · posted 2008-08-24 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

Software anomaly results in inaccurate information being printed out on the Delivery Report, even though the compounder performed the compounding correctly.

Action taken

Baxter sent the 3/28/08 Urgent Device Correction letter to affected customers, to the attention of the Director of Pharmacy, via first class mail to advise them of the potential inaccuracy of the Delivery Report due to a software anomaly. The accounts were instructed to review each delivery report for accuracy. If the report contains zero actual volumes the user must manually reprint the report. The letter outlined the process for reprinting the Delivery Report. Any questions were directed to the Baxter Nutritional Professional Services at 1-800-422-2751. The accounts were requested complete the enclosed reply form acknowledging receipt and understanding of the letter and dissemination of the information to their staff. A software upgrade will be provided. If you have questions about this letter or you did not receive this letter contact Baxter Nutrition Professional Services at 1-800-422-2751.

Root cause

Software design

Status

Terminated

Product code

LHI

Quantity affected

5 units

Distribution

Arizona, Minnesota, Wisconsin, Puerto Rico and Canada

Date initiated

2008-03-28

Date posted

2008-08-24

Date terminated

2008-08-25

Location

Round Lake, IL