Company: Baxter Healthcare Corp
Date of Enforcement Report: 12/25/02
Class: II
PRODUCT
HomeChoice and HomeChoice PRO Automated Peritoneal Dialysis Systems; Made in U.S.A.; Recall # Z-0334-3/Z-0339-3.
The following models are affected:
a) Baxter HomeChoice Automated PD System, catalog 5C4471,
115 volt;
b) Baxter HomeChoice Automated PD System, catalog 5C4474,
220 volt;
c) Yume Automated PD System, catalog T5C4441, 100 volt;
d) Baxter HomeChoice PRO Automated PD System, catalog
5C8310, 115 volt;
e) Baxter HomeChoice PRO Automated PD System,
catalog 5C8320, 220 volt;
f) Yume Plus Automated PD System, catalog T5C8300,
100 volt.
REASON
Possible overfill.
CODE
All HomeChoice and HomeChoice PRO Systems with software versions 8.51 and 8.52.
RECALLING FIRM/MANUFACTURER
Recalling Firm: Baxter Healthcare Corp., Round Lake, IL, by letters dated September 19 and 20, 2002.
Manufacturer: Baxter Healthcare Corporation, Largo, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12,667 units.
DISTRIBUTION
Nationwide and Internationally.
