Company: Baxter Healthcare Renal Division
Date 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 Clear-Flex PD products.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Division, Mc Gaw Park, IL, by notice on December 23, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
165 units.
DISTRIBUTION
Denmark and Sweden.
