Company: Baxter Healthcare Renal Div
Date of Enforcement Report: 5/19/04
Class: II
PRODUCT
a) Baxter Renal Software Suite (Renal Link and PD Link).
Recall # Z-0901-04;
b) Renalsoft software system. Recall # Z-0902-04.
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.
VOLUME OF PRODUCT IN COMMERCE
4,164 units.
CODE
a) Product codes 5M5590, 5M5591, 5M5592, 5M5593, 5M5594,
5M5595, 5M5596, 5M5603, 5M5604, R5C4532, R5C4534,
5M5597, 5M5541, 5M5541R, all software versions;
b) Product code RENLSFT, all software versions.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div., McGaw Park, IL, by letters dated April 12, 2004. Firm initiated recall is ongoing.
DISTRIBUTION
Nationwide.
