Mar

2003

Corp. Class III Baxter Healthcare

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.

About the author

Amy Sellers

Amy enjoys researching and writing about developments in medical technology and how that intersects with US law. She received her J.D. from the University of Florida Levin College of Law in 2020 and now works as a Regulatory Associate for SoftwareCPR®, a general-purpose regulatory consulting firm that is recognized globally for their expertise with standards and national regulations pertaining to medical device, mobile medical app, and HealthIT software.

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Corp. Class III Baxter Healthcare

Amy Sellers

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