Recall Z-2291-2011 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corp.
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.
| Date | May 25, 2011 (initiated Mar 29, 2011) |
| Status | Terminated |
| 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. |
| Root cause | Software design |
| 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 Dev |
| Quantity | 84 units |
| Distribution | Worldwide Distribution -- USA including Puerto Rico, and the country Canada. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.