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Terminated

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

FDA Recall Z-0394-05 · Posted 2005-01-13

Recalling FirmBaxter Healthcare Corp.
Recall StatusTerminated
Product CodeLHI
Date Initiated2004-12-20
Date Terminated2005-05-19
Product Quantity5 units

Reason for Recall

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

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

Root Cause

Other

Distribution Pattern

Arizona, Utah, North Carolina, Wisconsin and California.

Official Source

View FDA Recall →

Source: FDA Enforcement Report / Recall database. Always confirm against the official FDA record.

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