Company: Baxter Healthcare, Corp..
Date of Enforcement Report: 3/5/03
Class: III
PRODUCT
a) HomeChoice Automated Peritoneal Dialysis Systems;
Made in U.S.A.; catalog numbers 5C4471, 5C4471R, 5C4474,
5C4474R, T5C4441, T5C4441R. Recall # Z-0564-03;
b) HomeChoice PRO Automated Peritoneal Dialysis Systems;
Catalog numbers 5C8310, 5C8310R, R5C8320, R5C8320R,
T5C8300, T5C8300R. Recall # Z-0565-03.
REASON
Potential for low ultrafiltrate volumes when using the Low Fill Mode during continuous cycling peritoneal dialysis (CCPD) therapy.
CODE
a) All HomeChoice Systems with software versions 8.51 and
8.52;
b) All 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 December 23, 2002.
Manufacture: Baxter Healthcare, Corp., Largo, FL. Firm initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
12,667 units.
DISTRIBUTION
Nationwide and Internationally.
