Company: Baxter Healthcare Renal Division
Date of Enforcement Report 2/6/2008
Class:ll
PRODUCT
Baxter RenalSoft v.2.0 Patient Management Software Suite – HD Module;
clinical data management software, Recall # Z-0527-2008;
b) Baxter Renal Software Suite v.3.0 and v.3.1 – Renal Link HD Module; clinical data
management software; Recall # Z-0528-2008
REASON
Pre-Treatment/Post-Treatment Report errors: 1) The Heparin Bolus Value is displayed on Pre and Post Treatment Reports for patients with “No Heparin” orders (RenalSoft v2.0, Renal Software Suite v.3.0 and v.3.1), and 2) Withheld Medications are incorrectly displayed as Administered on the Pre-Treatment report (RenalSoft v.2.0 only).
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Renal Division, McGraw Park, IL, by letter, dated November 14, 2007.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing
VOLUME OF PRODUCT IN COMMERCE
73 units
DISTRIBUTION
Nationwide and Internationally
