—#99299

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.

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: catalog 2M8410, all software versions

Why it was recalled

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.

Root cause (FDA determination)

Software design

Action the firm took

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.

Recalling firm

Firm: Baxter Healthcare Corp. Rt.
Address: 120 & Wilson Rd, Round Lake, Illinois 60073

Distribution

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

Timeline

Recall initiated: 2011-03-29
Posted by FDA: 2011-05-25
Terminated: 2017-01-05
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #99299. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.