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

FDA device recall Z-0394-05 · posted 2005-01-13 · Terminated

Recall details

Recalling firm

Baxter Healthcare Corp.

Reason for recall

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

Action taken

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

Status

Terminated

Product code

LHI

Quantity affected

5 units

Distribution

Arizona, Utah, North Carolina, Wisconsin and California.

Date initiated

2004-12-20

Date posted

2005-01-13

Date terminated

2005-05-19

Location

Round Lake, IL