Recall Z-0394-05 ยท LHI Set, I.V. Fluid Transfer
Baxter Healthcare Corp.
Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073
| Date | Jan 13, 2005 (initiated Dec 20, 2004) |
| Status | Terminated |
| Reason | Logix-CM software version 3.0.4 has not completed its official release process. |
| Root cause | Other |
| Action | Urgent Product Recall letters dated 12/20/04 were sent to the end users via overnight mail. The accounts were informed that software version 3.0.4 has not been officially released and must be removed from their compounders. They were requested to complete and fax the customer reply form to Baxter at 847-270-5457, indicating if they are currently using Logix-CM software. Upon receipt of the reply form, Baxter will schedule a visit to the facility to remove Logix-CM software version 3.0.4 from their compounder and revert the software back to the configuration prior to Logix-CM 3.0.4 placement. |
| Quantity | 5 units |
| Distribution | Arizona, Utah, North Carolina, Wisconsin and California. |
| FDA record | Open on fda.gov |
510(k) clearances named in this recall
This recall record lists no 510(k) number.