—#36445

Product

Logix-CM Compounder Software, catalog 2M8400; Baxter Healthcare Corporation, Medication Delivery System, Round Lake, IL 60073

FDA product code: LHI — Set, I.V. Fluid Transfer
Device class: Class 2
Medical specialty: General Hospital
Affected lot / code info: Software version 3.0.4

Why it was recalled

Logix-CM software version 3.0.4 has not completed its official release process.

Root cause (FDA determination)

Other

Action the firm took

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. Any questions were directed to Baxter Clintec Nutrition, option 1, at 1-800-422-2751.

Recalling firm

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

Distribution

Distribution pattern: Arizona, Utah, North Carolina, Wisconsin and California.

Timeline

Recall initiated: 2004-12-20
Posted by FDA: 2005-01-13
Terminated: 2005-05-19
Status: —

Source: openFDA Device Recall endpoint. Recall record ID #36445. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.