FDA Recall Terminated

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.

Recall: Z-2291-2011 · Initiated March 29, 2011

Recall

Recall Number: Z-2291-2011
Event Number: 58420
Firm: Baxter Healthcare Corp. Rt.
FEI Number: 1416980
Product Code: LHI
Status: Terminated
Root Cause: Software design
Initiated: March 29, 2011
Posted: May 25, 2011
Terminated: January 5, 2017
Address: 120 & Wilson Rd, Round Lake, IL, 60073

Description

Reason

The LOGIX OE automated backup does not retain the three most recent backup files and instead will only retain the last three backups of the previous year. The software stores backup files in numeric order rather than chronological date order.

Action

Baxter Healthcare Corp. sent an URGENT DEVICE CORRECTION letter dated March 29, 2011, via first class mail to all affected customers. The letter identified the product, the problem and the action to be taken by the customer. It was discovered there is an issue with the LOGIX OE automated backup not retaining the three most recent backup files and instead will only retain the last three backups of the previous year. The accounts were requested to turn off the automated backup function on the LOGIX OE Software, and perform manual backups following the instructions included in the Urgent Device Correction letter, and retain a copy of the letter at each computer on which LOGIX OE Server is installed. The customer 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.

Distribution

Worldwide Distribution -- USA including Puerto Rico, and the country Canada.

Quantity

84 units