Company:Baxter Healthcare Corporation,
Date of Enforcement Report:5/10/2006
Class:lI

PRODUCT
a) RenalSoft Observational Study v.2.0 – HD Module, PD Module and Medical
Record Module; clinical data management software, Recall # Z-0831-06;
b) RenalSoft v.1.1 – PD Module; clinical data management software,
Recall # Z-0832-06;
c) Renal Software Suite v.3.1 – HD Module; clinical data management software,
Recall # Z-0833-06

REASON
There are software anomalies present that may increase the possibility of a medication error if the dialysis clinic software is used to track, record, or coordinate the administration of medications.

CODE
a) Version 2.0 – HD Modules, PD Modules and Medical Record Modules only;
b) Version 1.1 – PD Module only;
c) Version 3.1 – HD Module only

RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Div., Mc Gaw Park, IL, by letters dated March 29, 2006.
Manufacturer: Baxter Healthcare Corporation, Largo, FL, firm initiated recall is ongoing.

VOLUME OF PRODUCT IN COMMERCE
25 — U.S., 157 – International

DISTRIBUTION
Nationwide and Internationally