Company: Baxter Healthcare Renal DivisionDate of Enforcement Report: 2/9/05 Class: II PRODUCT HomeChoice PRO Automated Peritoneal Dialysis Systems. Recall # Z-0397-05. REASON A software anomaly may allow concentrated solution to be infused into the patient when the HomeChoice unit is used with Physioneal Clear-Flex PD products. CODE Units with software version 8.7 used with Physioneal...Read More

Company: Baxter HealthcareDate of Enforcement Report: 2/9/05 Class: II PRODUCT Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0394-05. REASON Logix-CM software version 3.0.4 has not completed its official release process. CODE Software version 3.0.4. RECALLING FIRM/MANUFACTURER Baxter Healthcare, Corp, Round Lake, IL, by letters dated December 20, 2004. Firm initiated recall is ongoing. VOLUME OF...Read More

Company: Baxter HealthcareDate of Enforcement Report: 2/9/05 Class: II PRODUCT Logix-CM Compounder Software, catalog 2M8400. Recall # Z-0392-05. REASON A software anomaly in the Logix CM software could result in a drug mixture being compounded without one of the ingredients if two drugs have the same indentifier in Logix and another order entry program being...Read More