Company: Baxter Healthcare Renal Div
Date of Enforcement Report: 6/16/04
Class: II
PRODUCT
a) HomeChoice and Yume Automated Peritoneal Dialysis
Systems; catalog numbers 5C4471, 5C4471R, 5C4474,
5C4474R, T5C4441, T5C4441R. Recall # Z-1012-04;
b) HomeChoice PRO and Yume PlusAutomated Peritoneal
Dialysis Systems; catalog numbers 5C8310, 5C8310R,
R5C8320, R5C8320R, T5C8300, T5C8300R. Recall # Z-1013-
04.
REASON
A software defect could result in a patient experiencing an overfill with software versions 8.5 and higher. The possibility of an overfill can occur when the Initial Drain Alarm Volume is set to OFF and a change to the volume is made at the Verify I-DRAIN:XXXXML prompt.
CODE
a) and b) All HomeChoice Systems with software versions 8.5 and higher.
RECALLING FIRM/MANUFACTURER
Baxter Healthcare Renal Div, Mc Gaw Park, IL, by letters dated May 24, 2004. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
17,026 units.
DISTRIBUTION
Nationwide and Internationally.
